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D013313: Stress Disorders, Post-Traumatic

Developed by Shray Alag, The Harker School
Sections: Correlations, Clinical Trials, and HPO

Correlations computed by analyzing all clinical trials.

Navigate: Clinical Trials and HPO


Correlated Drug Terms (45)


Name (Synonyms) Correlation
drug3278 Survey to assess Post traumatic stress and anxiety at inclusion and 6 months later Wiki 0.19
drug410 Basic Body Awareness Therapy Wiki 0.19
drug3331 Tele-delivered psychological intervention Wiki 0.19
Name (Synonyms) Correlation
drug1980 Medical Music Wiki 0.19
drug4040 questionnaire filling Wiki 0.19
drug376 BIO101 Wiki 0.19
drug1964 Maslach Burnout Inventory (MBI) Wiki 0.19
drug2057 MinnRAP Peer Support Program Wiki 0.19
drug540 Burnout Wiki 0.19
drug3671 Withings ScanWatch Wiki 0.19
drug1612 IgG antibodies immunoassay Wiki 0.19
drug2656 Prolonged Exposure Therapy Wiki 0.19
drug2398 PTSD Wiki 0.19
drug438 Bioarginina® Wiki 0.19
drug647 COVID-HIGIV Wiki 0.19
drug2748 Questionnary Wiki 0.19
drug697 Cannabis, Medical Wiki 0.19
drug405 Baricitinib or Anakinra Wiki 0.19
drug3725 airway management during sedation or general anesthesia Wiki 0.19
drug2095 Muscle Relaxation Therapy Wiki 0.19
drug416 Behaviour Change Technique Intervention to Improve Quality of Life Wiki 0.19
drug3275 Survey Group Wiki 0.19
drug3147 Spartan COVID-19 v2 System Wiki 0.19
drug2055 Mindfulness-Based Cognitive Therapy Wiki 0.19
drug2466 Phone call Wiki 0.19
drug1303 Feeling Good Digital App Wiki 0.19
drug3809 cries 13 questionnaire Wiki 0.19
drug1123 EMDR Wiki 0.19
drug1265 Eye Movement Desensitisation and Reprocessing Recent traumatic Event Protocol Wiki 0.19
drug2502 Placebo (saline) Wiki 0.19
drug1698 Intervention App Wiki 0.19
drug1696 Interpersonal Psychotherapy Wiki 0.19
drug444 Biological collection with nasopharyngeal samples, saliva, blood, stool and urine Wiki 0.19
drug3675 Written Summary of Rounds Wiki 0.19
drug3839 faecal sample collector Wiki 0.19
drug2140 Narrative Writing Wiki 0.19
drug2688 Psychological treatment Wiki 0.19
drug3100 Simple cognitive task intervention Wiki 0.13
drug3393 Therapeutic plasma exchange Wiki 0.13
drug318 Attention Placebo Wiki 0.13
drug695 Cannabidiol Wiki 0.13
drug1755 Ivermectin and Doxycycline Wiki 0.13
drug2892 Ruxolitinib Wiki 0.06
drug2730 Questionnaire Wiki 0.03
drug2490 Placebo Wiki 0.03

Correlated MeSH Terms (39)


Name (Synonyms) Correlation
D040921 Stress Disorders, Traumatic NIH 0.82
D004194 Disease NIH 0.25
D000070627 Chronic Traumatic Encephalopathy NIH 0.19
Name (Synonyms) Correlation
D005879 Tourette Syndrome NIH 0.19
D003424 Crohn Disease NIH 0.19
D000070642 Brain Injuries, Traumatic NIH 0.13
D015775 Fractures, Stress NIH 0.13
D000690 Amyotrophic Lateral Sclerosis NIH 0.13
D012640 Seizures NIH 0.13
D016472 Motor Neuron Disease NIH 0.13
D000068376 Compassion Fatigue NIH 0.13
D000067073 Psychological Trauma NIH 0.13
D006526 Hepatitis C NIH 0.13
D001008 Anxiety Disorders NIH 0.12
D001714 Bipolar Disorder NIH 0.11
D005356 Fibromyalgia NIH 0.09
D000755 Anemia, Sickle Cell NIH 0.09
D001930 Brain Injuries, NIH 0.08
D001927 Brain Diseases NIH 0.08
D001523 Mental Disorders NIH 0.08
D010300 Parkinsonian NIH 0.08
D003866 Depressive Disorder NIH 0.07
D016638 Critical Illness NIH 0.07
D015212 Inflammatory Bowel Diseases NIH 0.07
D003863 Depression, NIH 0.07
D012598 Scoliosi NIH 0.07
D009103 Multiple Sclerosis NIH 0.07
D000066553 Problem Behavior NIH 0.06
D059350 Chronic Pain NIH 0.06
D002055 Burnout, Professional NIH 0.06
D000077062 Burnout, Psychological NIH 0.04
D014947 Wounds and Injuries NIH 0.03
D013315 Stress, Psychological NIH 0.03
D045169 Severe Acute Respiratory Syndrome NIH 0.03
D018352 Coronavirus Infections NIH 0.03
D011014 Pneumonia NIH 0.02
D013577 Syndrome NIH 0.02
D003141 Communicable Diseases NIH 0.01
D007239 Infection NIH 0.01

Correlated HPO Terms (11)


Name (Synonyms) Correlation
HP:0100280 Crohn's disease HPO 0.19
HP:0006802 Abnormal anterior horn cell morphology HPO 0.13
HP:0100754 Mania HPO 0.13
Name (Synonyms) Correlation
HP:0007354 Amyotrophic lateral sclerosis HPO 0.13
HP:0001250 Seizure HPO 0.11
HP:0001298 Encephalopathy HPO 0.08
HP:0000716 Depressivity HPO 0.08
HP:0002037 Inflammation of the large intestine HPO 0.07
HP:0012532 Chronic pain HPO 0.06
HP:0000708 Behavioral abnormality HPO 0.06
HP:0002090 Pneumonia HPO 0.02

Clinical Trials

Navigate: Correlations   HPO

There are 29 clinical trials


1 Outcomes Mandate National Integration With Cannabis as Medicine for Prevention and Treatment of COVID-19

This will be a multistate, multicenter clinical study to determine the efficacy and safety of medical cannabis for a wide variety of chronic medical conditions.

NCT03944447
Conditions
  1. Chronic Pain
  2. Chronic Pain Syndrome
  3. Chronic Pain Due to Injury
  4. Chronic Pain Due to Trauma
  5. Fibromyalgia
  6. Seizures
  7. Hepatitis C
  8. Cancer
  9. Crohn Disease
  10. HIV/AIDS
  11. Multiple Sclerosis
  12. Traumatic Brain Injury
  13. Sickle Cell Disease
  14. Post Traumatic Stress Disorder
  15. Tourette Syndrome
  16. Ulcerative Colitis
  17. Glaucoma
  18. Epilepsy
  19. Inflammatory Bowel Diseases
  20. Parkinson Disease
  21. Amyotrophic Lateral Sclerosis
  22. Chronic Traumatic Encephalopathy
  23. Anxiety
  24. Depression
  25. Insomnia
  26. Autism
  27. Opioid-use Disorder
  28. Bipolar Disorder
  29. Covid19
  30. SARS-CoV Infection
  31. COVID-19
  32. Corona Virus Infection
  33. Coronavirus
Interventions
  1. Drug: Cannabis, Medical
MeSH:Infection Communicable Diseases Hepatitis C Coronavirus Infections Severe Acute Respiratory Syndrome Fibromyalgia Crohn Disease Inflammatory Bowel Diseases Parkin Parkinson Disease Multiple Sclerosis Brain Injuries Brain Injuries, Traumatic Seizures Motor Neuron Disease Amyotrophic Lateral Sclerosis Brain Diseases Tourette Syndrome Chronic Traumatic Encephalopathy Anemia, Sickle Cell Disease Syndrome Sclerosis Chronic Pain Wounds and Injuries Stress Disorders, Traumatic Bipolar Disorder Stress Disorders, Post-Traumatic
HPO:Abnormal anterior horn cell morphology Amyotrophic lateral sclerosis Bilateral tonic-clonic seizure Bipolar affective disorder Chronic pain Crohn's disease Encephalopathy Focal-onset seizure Generalized-onset seizure Inflammation of the large intestine Mania Seizure

Primary Outcomes

Description: Covid-19 infection rates in cannabis users will be compared to rates in the general population. Our online questionnaire responses will compare infection rates of cannabis users in this study against the Johns Hopkins University Coronavirus Research Center data (https://coronavirus.jhu.edu).

Measure: Prevention of COVID-19

Time: Five years

Description: Severity of persistent symptoms in cannabis users testing positive for active infection and/or antibodies will also be compared to the general population. Patients will answer the widely used FLU-PRO questionnaire, which asks about flu symptoms and severity, to capture diagnoses, symptoms, and medical interventions related to COVID-19. The data from cannabis user patients will be compared with national and international data surveys, such as the Covid Symptom Study (https://covid.joinzoe.com/us-2).

Measure: Treatment of COVID-19

Time: Five years

Description: The primary objective is to assess the efficacy and safety of medical cannabis as medicine for treatment of chronic pain and other chronic debilitating diseases. Pain will be measured by Brief Pain Inventory (BPI) numeric scale. Change from baseline in BPI will be assessed at 3-month intervals. For prospective associations between cannabis use and outcomes, use of a lagged mixed-effects models will examine temporal associations between cannabis use and pain severity, opioid sparing, and patient satisfaction. Data will be analyzed from baseline and the annual follow-up waves.

Measure: Treatment of Symptoms

Time: Five years

Secondary Outcomes

Description: Secondary objectives include evaluating increases or decreases in quality of life, and increases or decreases in concomitant opioid use. Satisfaction with treatment will be measured by a Visual Analog Score (VAS). Change From baseline in Satisfaction with treatment measured by (VAS) be assessed at 3-month intervals.

Measure: Cannabis Impact on Quality of Life

Time: Five years

Description: Tertiary objectives will examine preferences for routes of administration, and preferences for THC / CBD ratios. Categorical factors will be summarized using frequencies and percentages, while continuous measure distributions will be described using means, standard deviations, and quartiles of interest.

Measure: Cannabis Route and Dosing

Time: Five years

Description: Incidence of Treatment-Related Adverse Events will be measured by Physician Global Assessment (PGA) numeric scale. Number of participants with Treatment-Related Adverse Events will be assessed by CTCAE v4.0.

Measure: Monitoring Adverse Events

Time: Five years
2 "Psychological Burden in ICU Survivors of Severe COVID-19 Pneumonia, Their Relatives and Their Healthcare Providers" "Impact Psychologique de l'épidémie COVID-19 Chez Les Patients, Familles et Soignants de Reanimation" "BURDENCOV"

Coronavirus disease 2019 (COVID-19) is an infectious disease responsible for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The infection is highly contagious requiring restrictive and stressful measures for patients, family members and ICU healthcare providers. To avoid contagion, patient isolation has become the rule. For patients, these measures add stress to the ICU environment and deprive them of unrestricted family visits. Family members are not only left with fear but also many unanswered questions. In end-of-life situations, many family members are unable to say good-bye and unable to provide support to their loved-one throughout the process. The impact of exclusion or limited inclusion certainly needs to be explored. Moreover, ICU caregivers are having to face new challenges and to work in a unknown situation, juggling with both professional issues such as increased workload, working longer hours and safety issues, and personal issues such as child care and transport as well as family transmission of the virus. The main objective of this study is to demonstrate that the COVID-19 pandemic, as compared to seasonal flu and community acquired pneumonia, significantly increases post-traumatic stress disorder (PTSD) in family members of critically ill patients. PTSD-related symptoms will be assessed in family members using the IES-R (impact of event scale revised) during a telephone interview 90 days after ICU discharge. The IES-R is a 22-item self-report measure that assesses subjective distress caused by traumatic events. It will be compared across the three groups (COVID-19, FLU and CAP).

NCT04341519
Conditions
  1. Corona Virus Infection
  2. Post-traumatic Stress Disorder
Interventions
  1. Behavioral: PTSD
  2. Behavioral: Burnout
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia Stress Disorders, Traumatic Stress Disorders, Post-Traumatic
HPO:Pneumonia

Primary Outcomes

Description: Proportion of Family members with IES-R> 22 PTSD-related symptoms will be assessed in family members using the IES-R (impact of event scale revised) during a telephone interview 90 days after ICU discharge of corresponding patient. It si a scale ranging from 0 to 88. Weiss, DS.; Marmar, CR. The impact of event scale - revised. In: Wilson, JP.; Keane, TM., editors.Assessing psychological trauma and PTSD. New York: Guilford Press; 1997. p. 399-411

Measure: PTSD Family members sup 22

Time: 90 days

Secondary Outcomes

Description: Among Family members PTSD-related symptoms will be assessed in family members using the IES-R (impact of event scale revised)

Measure: PTSD Family members

Time: 90 days

Description: Among Patients PTSD-related symptoms will be assessed in family members using the IES-R (impact of event scale revised)

Measure: PTSD Patients

Time: 90 days

Description: Among healthcare providers PTSD-related symptoms will be assessed in family members using the IES-R (impact of event scale revised)

Measure: PTSD healthcare providers

Time: 2 months after official end of the Covid-19 peak

Description: Among Family members Symptoms of anxiety and depression using the HADS scale

Measure: HADS Family members

Time: 90 days

Description: Among Patients Symptoms of anxiety and depression using the HADS scale

Measure: HADS Patients

Time: 90 days

Description: Among Patients Mental and physical health-related quality of life as assessed by the SF36

Measure: SF36 Patients

Time: 90 days

Description: Among Family members Questionnaire describing their experience of the patient's ICU hospitalization

Measure: Questionnaire Family members

Time: 90 days

Description: Among Patients Questionnaire describing their experience of the patient's ICU hospitalization

Measure: Questionnaire Patients

Time: 90 days

Description: Among healthcare providers Questionnaire describing their experience of the patient's ICU hospitalization

Measure: Questionnaire healthcare providers

Time: 2 months after official end of the Covid-19 peak

Description: Among healthSymptoms of burnout on MBI scale as assessed by the Maslash Burnout Inventorycare providers

Measure: MBI healthcare providers

Time: 2 months after official end of the Covid-19 peak

Description: Job Strain as assessed by the Karasec instrument

Measure: Karasec instrument healthcare providers

Time: 2 months after official end of the Covid-19 peak
3 Anxiety and Work Resilience Among Tertiary University Hospital Workers During the COVID-19 Outbreak: An Online Survey

For limiting COVID-19 spreading, the World Health Organisation (WHO) recommended worldwide confinement on 2010. In France, unessential institutions were closed on March 14th and population confinement was decided on March 17th. Quarantine and/or confinement could lead to psychological effects such as confusion, suicide ideation, post-traumatic stress symptoms or anger COVID-19 outbreak highlighted a considerable proportion of health care workers (HCW) with depression, insomnia, anxiety and distress symptoms. In front line, facing the virus with the fear of contracting it and contaminate their closest. During previous outbreaks (H1N1, SARS), HCWs have been shown to experience such negative psychological effects of confinement as well as work avoidance behaviour and physical interaction reduction with infected patients (4-7). In France, Covid 19 outbeak led to increase ICU bed capacity with a full reorganization of the human resources. Some caregivers were reassigned to newly setup units admitting or not Covid-19 patients. In the same time, non-caregivers were also encouraged to work at home whenever possible. Thus, every hospital staff member's private and professional life could be altered by the Covid-19 outbreak. As all these changes in the daily life could induce psychological disturbances, the present study was aimed at assessing the acute anxiety level (main objective) of the staff in our Tertiary University Hospital, (6300 employees). Secondarily, the self-reported insomnia, pain, catastrophism and work avoidance behaviour levels were assessed

NCT04358640
Conditions
  1. Critical Illness
  2. Sars-CoV2
  3. SARS Pneumonia
  4. Coronavirus Infection
  5. Stress Disorders, Post-Traumatic
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia Critical Illness Stress Disorders, Post-Traumatic
HPO:Pneumonia

Primary Outcomes

Description: Mesured by STAY Scale

Measure: Anxiety

Time: 15 to 45 days after the beginning of the outbreak

Secondary Outcomes

Description: Participant suffering of Insomnia

Measure: Insomnia

Time: 15 to 45 days after the beginning of the outbreak

Description: Participant suffering of catastrophism

Measure: Catastrophism

Time: 15 to 45 days after the beginning of the outbreak
4 Level and Predictors of Trauma-symptoms Among Health Workers and Public Service Providers During the COVID-19 Outbreak

The aim of this study is to investigate the levels of trauma and mental symptoms (i.e., depression and anxiety) among health workers and public service providers during the strict social distancing government-initiated non-pharmacological interventions (NPI's) related to the COVID-19 pandemic. The study also aims to investigate predictors of trauma-symptoms.

NCT04374097
Conditions
  1. Post Traumatic Stress Disorder
  2. Anxiety
  3. Depression
MeSH:Depression Stress Disorders, Traumatic Stress Disorders, Post-Traumatic

Primary Outcomes

Description: PCL-5 is 20-item self-administered questionnaire which assesses the full domain of the DSM-5 PTSD diagnosis. The self-report rating scale is 0-4 for each symptom. Rating scale descriptors are: "Not at all," "A little bit," Moderately," "Quite a bit," and "Extremely."The PCL-5 has four subscales, corresponding to each of the symptom clusters in the DSM-5.

Measure: PTSD Checklist for DSM-5 (PCL-5)

Time: All data was collected between March 31st 2020 and April 7th 2020, a period where the NPIs (nonpharmacological interventions) against the COVID-19 pandemic were identical and constant in Norway

Secondary Outcomes

Description: The Patient Health Questionnaire 9 (PHQ-9; Kroenke, Spitzer & Williams, 2001) is used to measure symptoms of depression in accordance with the diagnostic criteria for major depressive disorder. The questionnaire consists of nine items where each is scored on a four-point Likert scale (0-3), with the range of scores from 0 to 27.

Measure: Patient Health Questionnaire 9 (PHQ-9)

Time: All data was collected between March 31st 2020 and April 7th 2020, a period where the NPIs (nonpharmacological interventions) against the COVID-19 pandemic were identical and constant in Norway

Description: The Generalized Anxiety Disorder 7 (GAD-7; Spitzer, Kroenke, Williams & Löwe, 2006) is a questionnaire consisting of seven items measuring symptoms of anxiety and worry. The items are scored on a four-point Likert scale (0-3), with the scores ranging from 0 to 21.

Measure: The Generalized Anxiety Disorder 7 (GAD-7)

Time: All data was collected between March 31st 2020 and April 7th 2020, a period where the NPIs (nonpharmacological interventions) against the COVID-19 pandemic were identical and constant in Norway]

Description: Symptoms of health anxiety was measured with two items from the validated Health Anxiety Inventory (HAI), one item measuring specific fear of being infected by coronavirus, and an item measuring fear of dying by the coronavirus. All items used a Likert scale from 0-3, and the new total score of health anxiety had a range from 0-12.

Measure: Health anxiety

Time: All data was collected between March 31st 2020 and April 7th 2020, a period where the NPIs (nonpharmacological interventions) against the COVID-19 pandemic were identical and constant in Norway
5 Psychological Impact of the Hospitalization of a Family Member in Intensive Care for Covid-19 Infection

The hospitalization of a patient in intensive care is a traumatic experience for his family members. With the current COVID-19 epidemic, in view of the high risk of contamination, drastic measures to limit the transmission are necessary, with the creation of spaces dedicated to the care of Covid+ patients, and family are not allowed to visit. At the Strasbourg University Hospital, visits were prohibited from the start of the epidemic. Information concerning the patient's state of health is therefore delivered to families by telephone, on call by the healthcare team only, every day before 6 p.m. or in the event of a serious event at any time. The primary purpose of this project is to assess the psychological impact of the hospitalization of a loved one in intensive care for Covid-19 infection at 3 months post-hospitalization, in a context of pandemic with ban on visits.

NCT04385121
Conditions
  1. Covid-19
  2. Stress Disorders, Post-Traumatic
  3. Anxiety
  4. Depression
Interventions
  1. Other: Questionnary
MeSH:Stress Disorders, Post-Traumatic

Primary Outcomes

Description: An overall score of 19 or more indicates a major depressive episode (HAD) and a total score of 22 as in favor of significant symptoms of acute stress (IES-R)

Measure: Existence of a post-intensive care syndrome-family ((combined score of the HAD ( Hospital Anxiety and Dépression scale) and IES-R ( Impact of Event Scale-Revised) questionnaires))

Time: 3 months
6 A Double-blinded Randomized Controlled Trial to Examine the Effectiveness of a Mobile-based Intervention to Reduce Mental Health Problems in Healthcare Workers at the Frontline Against COVID-19 in Spain: the PsyCovidApp Trial

This study aims at evaluating the effectiveness of a mobile phone based intervention to prevent and manage mental health problems in healthcare workers at the frontline against COVID-19 in Spain. The intervention will consist in psychoeducation, delivered via a mobile App. Participants will be followed up during two weeks. The primary outcome will be symptomatology of depression, anxiety or stress.

NCT04393818
Conditions
  1. Mental Health Disorder
  2. Depression
  3. Posttraumatic Stress Disorder
  4. Burnout
  5. Anxiety Disorders
Interventions
  1. Behavioral: Intervention App
MeSH:Disease Anxiety Disorders Stress Disorders, Post-Traumatic Mental Disorders

Primary Outcomes

Description: Depression, anxiety and stress scales (DASS21). Score range: 0 (worst outcome) to 21 (best outcome)

Measure: Depression, anxiety and stress

Time: 2 weeks

Secondary Outcomes

Description: Davidson Trauma Scale (DTS). The DTS is a 17-item, Likert-scale, self-report instrument that assesses the 17 DSM-IV symptoms of PTSD. Both a frequency and a severity score can be determined. The DTS yields a frequency score (ranging from 0 to 68), severity score (ranging from 0 to 68), and total score (ranging from 0 to 136). Higher scores are indicative a worse outcome.

Measure: Post-traumatic stress syndrome

Time: 2 weeks

Description: Insomnia Severity Index. Score range: 0 (best outcome) to 28 (worst outcome)

Measure: Insomnia

Time: 2 weeks

Description: General Self-Efficacy Scale. Score range: 10 (worst outcome) to 40 (best outcome)

Measure: Self Efficacy

Time: 2 weeks
7 Effectiveness of Basic Body Awareness Therapy in Survivors of Covid-19, Health Workers and Women Suffering From Gender-based Violence Regarding Post-traumatic Stress Disorders: A Randomized Clinical Trial

The aim of this randomized controlled clinical trial is to assess the effectiveness of Basic Body Awareness Therapy online in patients' survivors of Covid-19, health workers and women suffering from gender based violence regarding post-traumatic stress disorder in comparison with treatment as usual. The study will be multicentric in base Hospital Igualada and University of Lleida. The participants will be survivors of Covid-19 that had been inpatient in intensive care and health workers in first line with pandemia as doctors, nurse, physiotherapist, etc. More else, a new context emerge regarding gender based violence during the lockdown time. Outcomes variables will be measured regarding post-traumatic stress disorder, anxiety, depression, pain, quality of life and sleep. Fifty-four patients will be randomly assigned to a control group that will follow treatment as usual. The intervention group that will be received the same treatment adding Basic Body Awareness Therapy. The intervention will last 3 months twice a week at online format. At first month the intervention consisted of 12 movements and 15 min for sharing reflections about experiences. During the subsequent sessions, the treatment will be in group of 8 participants using the same methodology online. If the conditions of pandemia allow, the group will be presential in the health center at last month. Data analysis will performed using ANOVA of variables intragroup with repeated measurements. The analyses of the effects between groups will be performed throught ANOVA intergroup.

NCT04396314
Conditions
  1. PostTraumatic Stress Disorder
Interventions
  1. Behavioral: Basic Body Awareness Therapy
  2. Behavioral: Psychological treatment
MeSH:Stress Disorders, Traumatic Stress Disorders, Post-Traumatic

Primary Outcomes

Description: The DTS is a 17-item self-report measure that assesses the 17 DSM-IV symptoms of PTSD. Items are rated on 5-point frequency (0 = "not at all" to 4 = "every day") and severity scales (0 = "not at all distressing" to 4 = "extremely distressing"). Respondents are asked to identify the trauma that is most disturbing to them and to rate, in the past week, how much trouble they have had with each symptom. The DTS yields a frequency score (ranging from 0 to 68), severity score (ranging from 0 to 68), and total score (ranging from 0 to 136). It can be used to make a preliminary determination about whether the symptoms meet DSM criteria for PTSD. Scores can also be calculated for each of the 3 PTSD symptom clusters

Measure: Change in Davidson Trauma Scale (DTS)

Time: Baseline, 1 month , 3 months and 6 months follow up

Secondary Outcomes

Description: BDI consisting of 21 items with a score range from 0 to 63, with a higher score indicating a greater degree of depression.

Measure: Change in Beck Depression Inventory (BDI)

Time: Baseline, 1 month , 3 months and 6 months follow up

Description: Stai with statements scoring from 1 to 4; the whole score is from 0 to 60, with higher scores indicating a greater degree of anxiety

Measure: Change in State-Trait Anxiety Inventory (STAI)

Time: Baseline, 1 month , 3 months and 6 months follow up

Description: It measured quality of life, a generic tool whose scores range from 0 to 100; higher scores denote better quality of life. It contains 36 items grouped into eight subscales: physical functioning, physical role, bodily pain, general health, vitality, social functioning, emotional role, and mental health.

Measure: Change in Short Form 36 (SF36)

Time: Baseline, 1 month , 3 months and 6 months follow up

Description: VAS measures subjective characteristics that cannot be directly measured. The pain is measured from 0 to 10, with 0 representing "no pain" and 10 "unbearable pain".

Measure: Change in Visual Analogue Scale (VAS)

Time: Baseline, 1 month , 3 months and 6 months follow up

Description: Is an instrument used to measure the quality and patterns of sleep in the older adult. It differentiates "poor" from "good" sleep by measuring seven domains: subjective sleep, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction over the last month.The client self rates each of these seven areas of sleep. Scoring of the answers is based on a 0 to 3 scale, whereby 3 reflects the negative extreme on the Likert Scale. A global sum of "5" or greater indicates a "poor" sleeper. Although there are several questions that request the evaluation of the client's bedmate or roommate, these are not scored, nor reflected in the attached instrument.

Measure: Change in Pittsburgh Sleep Quality Index (PSQI)

Time: Baseline, 1 month , 3 months and 6 months follow up
8 The Professional Peer Resilience Initiative: Leveraging a Data-Driven Model to Maximize the Resilience of Healthcare Workers During the COVID-19 Pandemic

The Professional Peer Resilience Initiative (PPRI) study is an observational study aimed at understanding how symptoms of traumatic stress and resilience evolve over time in the University of Minnesota (UMN) healthcare workforce during the coronavirus disease 2019 (COVID-19) pandemic. The study is being conducted concurrently with a UMN peer support program called the MinnRAP program and will remotely administer quality of life and mental health surveys to healthcare workers before they start the MinnRAP program and throughout their participation in the program.

NCT04396600
Conditions
  1. Stress
  2. Stress Disorder
  3. Stress, Psychological
  4. Trauma, Psychological
  5. Anxiety
  6. Anxiety State
  7. Post Traumatic Stress Disorder
  8. Secondary Traumatic Stress
  9. Professional Quality of Life
  10. Stress Related Disorder
  11. Stress Reaction
  12. Stress Risk
  13. Mental Resilience
  14. Emotional Resilience
Interventions
  1. Behavioral: MinnRAP Peer Support Program
MeSH:Disease Compassion Fatigue Fractures, Stress Anxiety Disorders Stress Disorders, Traumatic Stress Disorders, Post-Traumatic Stress, Psychological Psychological Trauma

Primary Outcomes

Description: Professional Quality of Life Questionnaire (proQOL): min score of 10; max score of 50; higher scores mean worse outcome

Measure: Change in professional quality of life

Time: Before peer support program, through study completion (an average of 7 months)

Secondary Outcomes

Description: Stress Risk & Resilience Self-Index: min score 0; max score of 12; higher scores mean worse outcome

Measure: Change in mental health symptoms and resilience markers

Time: Before peer support program, through study completion (an average of 7 months)
9 COVID-19 EPIDEMIC Reorganisation of Cancer Patient Care: Self- Evaluation of Potential Post-traumatic Stress Disorder

The COVID-19 pandemic is a traumatic event which could lead to a greater risk of developing post-traumatic stress disorder, especially in cancer patients who feel more at risk of contracting the virus, and fear developing serious symptoms. The study's primary objective is to measure the presence of a potential post-traumatic stress disorder in cancer patients, and to assess the associated factors. The secondary objectives are to measure patients' anxiety, as well as their perception of both the management of their cancer care, and their fear of a cancer recurrence. It is a prospective, multi-centric study using self-assessing survey offered to cancer patients currently under ongoing care or treatment. The surveys will be sent by post at the beginning of the study, and again 6 months later. Expecting a participation rate of 40%, 4000 patients will be contacted, over a period of 3 months, in order to receive 1600 responses, and 640 responses 6 months later. Researching the factors associated with the appearance of post-traumatic stress could lead to better screening of patient disorders in highly anxiety-provoking crisis situations. As a result, it would lead to an improvement of their care, healthcare organization, and their follow-up in the case of a new epidemic or any other stressful event of this magnitude. Furthermore, promoting the patient's expression capabilities favors their implication in their care, and facilitates the development of health democracy.

NCT04401046
Conditions
  1. Cancer
Interventions
  1. Other: Survey to assess Post traumatic stress and anxiety at inclusion and 6 months later
MeSH:Stress Disorders, Traumatic Stress Disorders, Post-Traumatic

Primary Outcomes

Measure: Score of the Impact of Event Scale Revisited scale

Time: at inclusion and 6 months later

Secondary Outcomes

Description: The factors associated with post traumatic stress, measured by the Impact of Event Scale Revisited scale

Measure: Factors associated with post-traumatic stress disorder

Time: at inclusion and 6 months later

Description: The measure of anxiety, measured by the State-Trait Anxiety Questionnaire

Measure: Measure of the patient's anxiety

Time: at inclusion and 6 months later

Measure: proportion of patients perceiving poorer management of their cancer care since the start of the COVID-19 epidemic.

Time: at inclusion and 6 months later

Measure: proportion of patients perceiving the implementation of all necessary measures to reduce the risk of exposure to COVID-19

Time: at inclusion and 6 months later

Measure: proportion of patients stating that remote consultation is as useful as a face-to-face consultation

Time: at inclusion and 6 months later

Measure: proportion of patients with access to a clinical psychology consultation (at the hospital or on the phone)

Time: at inclusion and 6 months later

Measure: Score on the cancer recurrence scale

Time: at inclusion and 6 months later
10 Psychological Impact of the Covid-19 Pandemic on Student Nurses :Prevalence and Risk Factors of Acute Post-traumatic Stress Symptoms 1 Month After the Epidemic Peak

The World Health Organization (WHO) declared in early 2020 the emergence of a new highly contagious SARS-CoV-2 coronavirus responsible for a global public health emergency. In France, the first cases of contamination have been reported since the end of January 2020, and the first death in mid-February 2020. Then, data published by Public Healh France reported an increasing and rapidly exponential number of contaminations. First cases have been identified on a cluster mode, then rapidly spreading in some French departments and regions, indicating rapid kinetics of virus spread. Given the magnitude of the situation both French territory and neighboring European territories (mainly Italy), the government mobilized the entire health system to critically manage this epidemic. This exceptional and unprecedented pandemic deeply impacted the health structures, disrupting healthcare organizations. All caregivers, including all student nurses, actively participated in the mobilization and strengthening of care teams. The health crisis exposed the population of caregivers to potentially traumatic events which can have major repercussions on their health state. The description and identification of the risk factors of the occurrence of post traumatic stress disorders in student nurses during the health crisis would allow to provide avenues for improving training devices and to facilitate health workers access to specific psychological care particularly dedicated to the student nurses population needs.

NCT04402229
Conditions
  1. Nurse
  2. Student
  3. Post Traumatic Stress Disorder
  4. COVID-19
MeSH:Stress Disorders, Traumatic Stress Disorders, Post-Traumatic

Primary Outcomes

Description: Proportion of students with IES-R> 22 PTSD-related symptoms. Impact of Event Scale - Revised (IES-R) is a 22-item self-report measure that assesses subjective distress caused by traumatic events. ... The IES-R yields a total score (ranging from 0 to 88) and subscale scores can also be calculated for the Intrusion, Avoidance, and Hyperarousal subscales.

Measure: Prevalence of PTSD-related symptoms assessed by the IES-R

Time: 1 month after the end of the French epidemic Covid-19 peak

Secondary Outcomes

Description: IES-R> 22 PTSD-related symptoms in the total population of students nurses( 3 years training)

Measure: PTSD-related symptoms assessed by the IES-R in the total population of students nurses

Time: 1 month after the end of the French epidemic Covid-19 peak

Description: IES-R> 22 PTSD-related symptoms in each population of students nurses of first-, second-, and third-year.

Measure: PTSD-related symptoms assessed by the IES-R according to student's years of school

Time: 1 month after the end of the French epidemic Covid-19 peak
11 COVID-19 Caregiver Emotional Support

The experience of a loved one's stay in a COVID-19 intensive care unit (ICU), either intubated or on respiratory support, forces family caregivers (hereafter 'caregivers') to face core existential fears, such as uncertainty and death. It also poses a serious threat to basic human needs for autonomy, competence, and relatedness, as family caregivers have no control over the illness, and limited prior competence in dealing with critical illness. COVID-19 likely aggravates this experience, as social distancing cuts caregivers off from visiting patients in the ICU, from using their usual social supportive network and the threat of infection extends to caregivers themselves, their children and family. Combined, these extreme circumstances put caregivers in emotional turmoil and in need of psychological support and assistance in managing difficult emotions. ICU caregivers are at risk of developing clinically relevant symptoms of anxiety or posttraumatic stress. During the patient's ICU stay, caregivers experience peri-traumatic distress, such as helplessness, grief, frustration and anger, that may predict later posttraumatic stress disorder (PTSD). Symptoms of anxiety and PTSD may last for months to years after the patient's discharge. Further, caregivers of patients who die in an ICU may be at greater risk of prolonged grief disorder. Supportive interventions may reduce psychological late effects in ICU caregivers, but the primary focus of the majority of interventions has been on communication or surrogate decision making. The CO-CarES study aims to develop and test the feasibility of a tele-delivered psychological intervention to enable caregivers of ICU patients with COVID-19 to better endure the overwhelming uncertainty and emotional strain and reduce the risk of posttraumatic stress and prolonged grief. The study hypothesizes that providing psychological intervention during and after the patients' hospitalization, can decrease peri-traumatic distress during ICU hospitalization and decrease risk of post-traumatic stress, anxiety, depression and perceived stress following discharge, as well as prolonged grief in bereavement. A secondary hypothesis is that changes in emotion regulation mediate effects of the intervention on long-term psychological outcomes.

NCT04409821
Conditions
  1. Posttraumatic Stress Disorder
  2. Prolonged Grief Disorder
  3. COVID
Interventions
  1. Behavioral: Tele-delivered psychological intervention
MeSH:Disease Stress Disorders, Post-Traumatic

Primary Outcomes

Description: Rate of consent among informed eligible participants

Measure: Recruitment rate

Time: At inclusion

Description: Rates of completion of intervention sessions among participants

Measure: Completion rate

Time: During and post-intervention (1 month)

Description: Symptoms of peri-traumatic distress, min. score 0, max score 24, higher score corresponds to worse distress

Measure: Peri-traumatic distress inventory (negative emotions)

Time: Pre-post intervention (1 month after discharge/death)

Description: Posttraumatic stress, min. score 6, max score 24, higher score corresponds to worse distress

Measure: Impact of Events Scale (6 item)

Time: 1 month post intervention

Description: Posttraumatic stress, min. score 6, max score 24, higher score corresponds to worse distress

Measure: Impact of Events Scale (6 item)

Time: 6 months post intervention

Description: Posttraumatic stress, min. score 6, max score 24, higher score corresponds to worse distress

Measure: Impact of Events Scale (6 item)

Time: 12/13 months post intervention

Secondary Outcomes

Description: Prolonged Grief, scored according to diagnostic criteria for prolonged grief disorder

Measure: Prolonged Grief-13-scale

Time: 6 and 13 months

Description: Symptoms of depression, min. score 8, max score 40, higher score corresponds to worse symptoms

Measure: PROMIS Depression (8 item scale)

Time: Baseline to 1, 6, and 12/13 months

Description: Symptoms of anxiety, min. score 8, max score 40, higher score corresponds to worse symptoms

Measure: PROMIS Anxiety (8 item scale)

Time: Baseline to 1, 6, and 12/13 months

Description: Perceived stress, min. score 0, max score 16, higher score corresponds to worse stress

Measure: Perceived Stress Scale (4 item)

Time: Baseline to 1, 6, and 12/13 months

Other Outcomes

Description: Worry, min. score 3, max score 15, higher score corresponds to greater worry

Measure: Short Penn State Worry Questionnaire (3 items)

Time: Baseline to 1, 6, and 12/13 months

Description: Brooding, min. score 5, max score 20, higher score corresponds to greater brooding/rumination

Measure: Brooding subscale of Ruminative Responses Scale

Time: Baseline to 1, 6, and 12/13 months

Description: Intolerance of uncertainty, min score 2, max score 8, greater score indicates greater uncertainty intolerance

Measure: Intolerance of uncertainty Scale (2 item)

Time: Baseline to 1, 6, and 12/13 months
12 PTSD in Health Workers During COVID-19 Pandemia

The purpose of the questionnaire is to find risk factors for the development of post-traumatic stress disease (PTSD) in health workers during COVID-19 pandemy.

NCT04424771
Conditions
  1. COVID
  2. Post Traumatic Stress Disorder
Interventions
  1. Behavioral: Maslach Burnout Inventory (MBI)
MeSH:Stress Disorders, Traumatic Stress Disorders, Post-Traumatic

Primary Outcomes

Description: PTSD consists in job burnout, including emotional exhaustion, depersonalization, and personal accomplishment.

Measure: Number of patients with diagnosis of PTSD.

Time: Through study completion, an average of 1 months
13 PTSD Symptoms Among Health Workers and Public Service Providers After the COVID-19 Outbreak: A 3 Month Follow up

The aim of this study is to investigate the levels of trauma and mental symptoms (i.e., depression and anxiety) among health workers and public service providers 3 months after (T2) the strict social distancing government initiated non-pharmacological interventions (NPIs) related to the COVID-19 pandemic (T1), in a period of lifted distancing protocols. The study also aims to investigate predictors of trauma-symptoms, by analyzing how predictors measured during the COVID-19 pandemic are associated with change in PTSD symptoms from T1 to T2.

NCT04442243
Conditions
  1. Post Traumatic Stress Disorder
  2. Anxie
  3. Anxiety
  4. Depression
MeSH:Stress Disorders, Traumatic Stress Disorders, Post-Traumatic

Primary Outcomes

Description: PCL-5 is a 20-item self-administered questionnaire which assesses the full domain of the DSM-5 PTSD diagnosis. The self-report rating scale is 0-4 for each symptom. Rating scale descriptors are: "Not at all," "A little bit," Moderately," "Quite a bit," and "Extremely."The PCL-5 has four subscales, corresponding to each of the symptom clusters in the DSM-5.

Measure: PTSD Checklist for DSM-5 (PCL-5)

Time: Data is set to be collected starting from 22th of June. The data collection period will last no longer than three weeks depending on the response to the questionnaire

Secondary Outcomes

Description: The Patient Health Questionnaire 9 (PHQ-9; Kroenke, Spitzer & Williams, 2001) is used to measure symptoms of depression in accordance with the diagnostic criteria for major depressive disorder. The questionnaire consists of nine items where each is scored on a four-point Likert scale (0-3), with the range of scores from 0 to 27.

Measure: Patient Health Questionnaire 9 (PHQ-9)

Time: Data is set to be collected starting from 22th of June. The data collection period will last no longer than three weeks depending on the response to the questionnaire

Description: The Generalized Anxiety Disorder 7 (GAD-7; Spitzer, Kroenke, Williams & Löwe, 2006) is a questionnaire consisting of seven items measuring symptoms of anxiety and worry. The items are scored on a four-point Likert scale (0-3), with the scores ranging from 0 to 21.

Measure: Generalized Anxiety Disorder 7 (GAD-7)

Time: Data is set to be collected starting from 22th of June. The data collection period will last no longer than three weeks depending on the response to the questionnaire

Description: WEMWBS short version consist of 7 items

Measure: The Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS)

Time: Data is set to be collected starting from 22th of June. The data collection period will last no longer than three weeks depending on the response to the questionnaire
14 Alterations of Gut Microbiome in the Frontline Medical Staff Under the Stress of Fighting Against 2019-nCoV

With the outbreak of 2019 novel coronavirus (2019-nCoV), the frontline medical workers faced enormous stress, including a high risk of infection and inadequate protection from contamination, isolation, patients with negative emotions, a lack of contact with their families, and exhaustion, which may cause mental health problems. The investigators plan to collect the faecal samples and clinical assessments from a part of frontline medical workers in three time points to analyse the changing profile of gut microbiome according to outcomes of 16s rRNA sequencing. The samples from the matched health controls will also be sequenced to compare with the exposed group in gut microbiome community.

NCT04443075
Conditions
  1. Stress Disorders, Post-Traumatic
Interventions
  1. Device: faecal sample collector
MeSH:Stress Disorders, Post-Traumatic

Primary Outcomes

Description: Gut microbiome composition will be anaylysed using 16S rRNA sequencing.

Measure: Gut microbiome composition of exposed group

Time: immediately after the frontline workers come back to Xi'an

Description: Gut microbiome composition will be anaylysed using 16S rRNA sequencing.

Measure: Gut microbiome composition of exposed group

Time: immediately after the frontline workers isolated for two weeks

Description: Gut microbiome composition will be anaylysed using 16S rRNA sequencing.

Measure: Gut microbiome composition of exposed group

Time: immediately after the frontline workers going back to normal work for one month

Description: Gut microbiome composition will be anaylysed using 16S rRNA sequencing.

Measure: Gut microbiome composition of non-exposed group

Time: During the procedure of collecting faecal samples from exposed group

Description: It's a self-report measure assessing subjective distress resulting from a traumatic life event, with a total score of 0-88. Higher score means a worse outcome

Measure: The Impact of Event Scale-Revised (IES-R) of exposed group

Time: immediately after the frontline workers come back to Xi'an

Description: It's a self-report measure assessing subjective distress resulting from a traumatic life event, with a total score of 0-88. Higher score means a worse outcome

Measure: The Impact of Event Scale-Revised (IES-R) of exposed group

Time: immediately after the frontline workers isolated for two weeks

Description: It's a self-report measure assessing subjective distress resulting from a traumatic life event, with a total score of 0-88. Higher score means a worse outcome

Measure: The Impact of Event Scale-Revised (IES-R) of exposed group

Time: immediately after the frontline workers going back to normal work for one month

Description: It's a self-report measure assessing subjective distress resulting from a traumatic life event, with a total score of 0-88. Higher score means a worse outcome

Measure: The Impact of Event Scale-Revised (IES-R) of non-exposed group

Time: During the procedure of collecting faecal samples from non-exposed group

Secondary Outcomes

Description: It's a self-administered measure assessing subjective common mental health with a total score of 0-30. Higher score means a worse outcome.

Measure: The 15-item Patient Health Questionnaire (PHQ-15) of exposed group

Time: immediately after the frontline workers come back to Xi'an

Description: It's a self-administered measure assessing subjective common mental health with a total score of 0-30. Higher score means a worse outcome.

Measure: The 15-item Patient Health Questionnaire (PHQ-15) of exposed group

Time: immediately after the frontline workers isolated for two weeks

Description: It's a self-administered measure assessing subjective common mental health with a total score of 0-30. Higher score means a worse outcome.

Measure: The 15-item Patient Health Questionnaire (PHQ-15) of exposed group

Time: immediately after the frontline workers going back to normal work for one month

Description: It's a self-administered measure assessing subjective common mental health with a total score of 0-30. Higher score means a worse outcome.

Measure: The 15-item Patient Health Questionnaire-15 (PHQ-15) of non-exposed group

Time: During the procedure of collecting faecal samples from non-exposed group

Description: It's a self-report measure widely used for major depression screening with a total score of 0-27. Higher score means a worse outcome.

Measure: The 9-item Patient Health Questionnaire (PHQ-9) of exposed group

Time: immediately after the frontline workers come back to Xi'an

Description: It's a self-report measure widely used for major depression screening with a total score of 0-27. Higher score means a worse outcome.

Measure: The 9-item Patient Health Questionnaire (PHQ-9) of exposed group

Time: immediately after the frontline workers isolated for two weeks

Description: It's a self-report measure widely used for major depression screening with a total score of 0-27. Higher score means a worse outcome.

Measure: The 9-item Patient Health Questionnaire (PHQ-9) of exposed group

Time: immediately after the frontline workers going back to normal work for one month

Description: It's a self-report measure widely used for major depression screening with a total score of 0-27. Higher score means a worse outcome.

Measure: The 9-item Patient Health Questionnaire (PHQ-9) of non-exposed group

Time: During the procedure of collecting faecal samples from non-exposed group

Description: It is a practical self-report anxiety questionnaire with a total score of 0-21. Higher score means a worse outcome.

Measure: The 7-item Generalized Anxiety Disorder Scale (GAD-7) of exposed group

Time: immediately after the frontline workers come back to Xi'an

Description: It is a practical self-report anxiety questionnaire with a total score of 0-21. Higher score means a worse outcome.

Measure: The 7-item Generalized Anxiety Disorder Scale (GAD-7) of exposed group

Time: immediately after the frontline workers isolated for two weeks

Description: It is a practical self-report anxiety questionnaire with a total score of 0-21. Higher score means a worse outcome.

Measure: The 7-item Generalized Anxiety Disorder Scale (GAD-7) of exposed group

Time: immediately after the frontline workers going back to normal work for one month

Description: It is a practical self-report anxiety questionnaire with a total score of 0-21. Higher score means a worse outcome.

Measure: The 7-item Generalized Anxiety Disorder Scale (GAD-7) of non-exposed group

Time: During the procedure of collecting faecal samples from non-exposed group

Description: It is a self-report questionnaire that is widely used to assess several dimensions of sleep with a total score of 0-21. Higher score means a worse outcome

Measure: The Pittsburgh Sleep Quality Index (PSQI) of exposed group

Time: immediately after the frontline workers come back to Xi'an

Description: It is a self-report questionnaire that is widely used to assess several dimensions of sleep with a total score of 0-21. Higher score means a worse outcome

Measure: The Pittsburgh Sleep Quality Index (PSQI) of exposed group

Time: immediately after the frontline workers isolated for two weeks

Description: It is a self-report questionnaire that is widely used to assess several dimensions of sleep with a total score of 0-21. Higher score means a worse outcome

Measure: The Pittsburgh Sleep Quality Index (PSQI) of exposed group

Time: immediately after the frontline workers going back to normal work for one month

Description: It is a self-report questionnaire that is widely used to assess several dimensions of sleep with a total score of 0-21. Higher score means a worse outcome

Measure: The Pittsburgh Sleep Quality Index (PSQI) of non-exposed group

Time: During the procedure of collecting faecal samples from non-exposed group

Description: It is a self-report instrument widely used to measure clinical psychiatric symptoms and mental health status, with a total score of 0-360. Higher means a worse outcome.

Measure: The Symptom Check List 90 (SCL-90) of exposed group

Time: immediately after the frontline workers come back to Xi'an

Description: It is a self-report instrument widely used to measure clinical psychiatric symptoms and mental health status, with a total score of 0-360. Higher means a worse outcome.

Measure: The Symptom Check List 90 (SCL-90) of exposed group

Time: immediately after the frontline workers isolated for two weeks

Description: It is a self-report instrument widely used to measure clinical psychiatric symptoms and mental health status, with a total score of 0-360. Higher means a worse outcome.

Measure: The Symptom Check List 90 (SCL-90) of exposed group

Time: immediately after the frontline workers going back to normal work for one month

Description: It is a self-report instrument widely used to measure clinical psychiatric symptoms and mental health status, with a total score of 0-360. Higher means a worse outcome.

Measure: The Symptom Check List 90 (SCL-90) of non-exposed group

Time: During the procedure of collecting faecal samples from non-exposed group
15 Psychological Impact of Admission With Covid-19 During the SARS-CoV-2 Pandemic: Naturalistic Cohort Study With a Digital Intervention

Studies have shown that admission to hospital during a coronavirus epidemic is associated with increased levels of anxiety, depression and panic disorder. During the SARS-CoV-2 pandemic in North London the Royal Free Hospital admitted over 500 patients with Covid-19. As part of the standard of care, these patients are screened at 8 weeks post discharge for signs of anxiety and depression. The Feeling Good app is a NHS approved digital application which utilises applied relaxation, mindfulness based cognitive therapy and positive visualisation through audio tracks for the treatment of anxiety and depression. This is a naturalistic cohort study aimed to track the post illness psychological symptoms of those who have been admitted with Covid-19 to the Royal Free hospital up to 5-7 months after discharge. The study population is those who are exhibiting anxiety or depressive symptoms as measure by the PHQ-2 or TSQ questionnaires. All those with symptoms will be offered free access to a NHS approved app for anxiety and depression, and followed up for 3 months after recruitment to track changes to their symptoms.

NCT04449627
Conditions
  1. Anxiety Disorders
  2. Post Traumatic Stress Disorder
  3. Depressive Disorder
  4. Covid19
Interventions
  1. Other: Feeling Good Digital App
MeSH:Disease Depressive Disorder Stress Disorders, Traumatic Anxiety Disorders Stress Disorders, Post-Traumatic
HPO:Depressivity

Primary Outcomes

Description: Generalised anxiety disorder score (GAD-7) scale. Score 0-21, with a higher score associated with greater anxiety symptoms. Scores of 5, 10, and 15 represent cut-points for mild, moderate, and severe anxiety, respectively. GAD-7 score at baseline will be controlled for.

Measure: Anxiety as measured by generalised anxiety disorder score (GAD-7) scale

Time: Day 14

Secondary Outcomes

Description: The Patient Health Questionnaire (PHQ-9) is a screening tool for the identification of depressive disorders, which has been validated for use in primary care. Each of the nine items in the questionnaire is based on the DSM diagnostic criteria for clinical depression. The PHQ-9 is scored out of 27 according to severity, where score of 5-9 indicates mild depression, 10-14 moderate, 15-19 moderately severe, and 20 or above severe depression.

Measure: Depression as measured by the patient health questionnaire 9 (PHQ-9)

Time: 14 days and week 12

Description: The Trauma screening questionnaire (TSQ) is a 10 point scale used to identify symptoms of post traumatic stress disorder (PTSD), with a score between 0 and 10, with a score of 6 or higher scored as positive.

Measure: Trauma as measured by Trauma screening questionnaire (TSQ)

Time: 12 weeks

Description: Generalised anxiety disorder score (GAD-7) scale. Score 0-21, with a higher score associated with greater anxiety symptoms. Scores of 5, 10, and 15 represent cut-points for mild, moderate, and severe anxiety, respectively. GAD-7 score at baseline will be controlled for.

Measure: Anxiety as measured by generalised anxiety disorder score (GAD-7) scale

Time: Week 12

Other Outcomes

Description: Risk factors for psychological distress from admission with Covid-19 will be collected, these will include, age, gender, ethnicity, length of hospital stay, oxygen requirement, co-morbidites, years of education, smoking status, occupation.

Measure: Risk associated with distress

Time: Baseline analysis

Description: Framework analysis. Qualitative feedback of patient experience. Semi structured interviews of a subset of patients will be performed to gain further insight into the patient experience. These will be analysed using a framework thematic analysis, to identify themes which will then be used to code the text.

Measure: Qualitative analysis

Time: Baseline
16 EMERALD: Can a Virtual Eye Movement Desensitisation and Reprocessing Intervention Improve Psychological Outcome Following Covid-19 Related Critical Illness: A Feasibility Trial

Primary objective is to evaluate the feasibility of delivering an online early Eye Movement Desensitisation Reprocessing (EMDR) Recent Traumatic Events Protocol (R-TEP) to patients who have survived Covid-19 related critical illness, within the context of a randomised controlled trial (RCT). This will inform the design of a future RCT investigating the effectiveness of EMDR R-TEP in reducing psychological symptoms, for adult survivors of intensive care.

NCT04455360
Conditions
  1. Post Traumatic Stress Disorder
  2. Intensive Care Psychiatric Disorder
  3. Anxiety Disorders
  4. Depression
  5. Critical Care
  6. COVID
Interventions
  1. Other: Eye Movement Desensitisation and Reprocessing Recent traumatic Event Protocol
MeSH:Disease Critical Illness Stress Disorders, Traumatic Anxiety Disorders Stress Disorders, Post-Traumatic Mental Disorders Problem Behavior
HPO:Behavioral abnormality

Primary Outcomes

Description: Feasibility will be determined by the following measures: Able to recruit >30% of eligible patients approached Complete early EMDR intervention programme in 75% or more of trial participants randomised to intervention. Protocol adherence Assignment of causality of serious events will be assessed by the chief investigator. Events attributable to trial procedures will be reviewed by trial management board, study sponsor and the research ethics committee, in order to determine ongoing feasibility. Outcome measures completed in 75% or more of trial participants

Measure: Feasibility of recruitment, intervention adherence, incidence of treatment related adverse events and trial completion to final assessment timepoints

Time: 12 months

Secondary Outcomes

Description: The PTSD Checklist-Civilian Version (PCL-C) is a validated, standardised self-reporting questionnaire for PTSD comprising of 17 items that correspond to key PTSD symptoms

Measure: Post-Traumatic stress disorder

Time: 6 months post-hospital discharge

Description: Hospital Anxiety and Depression Scale (HADS) is a 14-item, self-reported measure with 7-items relating to symptoms of anxiety and 7-items relating to depression

Measure: Anxiety and depression

Time: 6 months

Description: Montreal Cognitive Assessment (MoCA) is a validated tool, used to detect cogntive impairment

Measure: Cognitive function

Time: 6 months post-hospital discharge

Description: EQ5D -5L comprises five quality-of-life dimensions; mobility, self-care, usual activities, pain/discomfort andanxiety/depression.

Measure: Health Related Quality of Life

Time: 6 months post-hospital discharge

Description: WHODAS 2.0 is a generic assessment tool that produces standarised disability levels and profiles

Measure: Health and disability

Time: 6 months post-hospital discharge

Description: Wrist worn physical activity monitoring

Measure: Physical activity

Time: 6 months post-hospital discharge

Description: Patient generated subjective global assessment

Measure: Nutritional status

Time: 6 months post-hospital discharge
17 Reducing Intrusive Memories After Trauma Via a Simple Cognitive Intervention During COVID-19 in Hospital Staff: "EKUT-P" (Enkel Kognitiv Uppgift Efter Trauma Under COVID-19 - sjukvårdspersonal) - A Randomized Controlled Trial (RCT)

This research study is designed to investigate the effects of a remotely delivered simple cognitive task (a memory cue followed by playing the computer game "Tetris" with mental rotation instructions) on intrusive memories ("flashbacks") and other symptoms after a traumatic event(s). Hospital staff who experienced a work-related traumatic event(s) during the COVID-19 pandemic will be randomly allocated to either the simple cognitive task intervention or control. Randomization to assigned intervention occurs on Day 1, after completion of baseline measures (note: baseline measures are not used in randomization process). Baseline measures include questionnaires on Day 1 and an intrusive memory diary during the previous week (Week -1). Participants will be followed up at one week and one month, and where possible 3 and 6 months. It is predicted that participants given the simple cognitive task intervention will develop fewer intrusive memories, less severe related clinical symptoms, and will show higher functioning (e.g. at work) than those who are not. This will inform the future development of a simple technique to prevent distressing psychological symptoms after a traumatic event(s). Implementation and training aspects regarding remote recruitment and intervention delivery in a hospital context will also be explored. Participants use e.g. their smartphone for part of the intervention in the study.

NCT04460014
Conditions
  1. Intrusive Memories of Traumatic Event(s)
  2. Post Traumatic Stress Disorder
Interventions
  1. Behavioral: Simple cognitive task intervention
  2. Behavioral: Attention Placebo
MeSH:Stress Disorders, Traumatic Stress Disorders, Post-Traumatic

Primary Outcomes

Description: Number of intrusive memories of traumatic event(s) recorded by participants in a brief diary daily (morning, afternoon, evening and night) for 7 days.

Measure: Number of intrusive memories of traumatic event(s)

Time: Week 5

Secondary Outcomes

Description: Number of intrusive memories of traumatic event(s) recorded by participants in a brief diary daily (morning, afternoon, evening and night) for 7 days.

Measure: Number of intrusive memories of traumatic event(s)

Time: Week -1 and Week 1

Description: A single item measuring the frequency of intrusive/unwanted memories of the traumatic event(s) in the previous week on a 7-point scale (from "never" to "many times a day", with a follow-up question to specify the number if necessary) that will be used as a convergent measure for medical hospital staff who may face time constraints completing the diary.

Measure: Intrusion questionnaire - frequency item

Time: Baseline (Day 1), Week 1 and 5 and 1, 3, and 6 month follow-up

Description: 5 self-rated items measuring the characteristics of intrusive/unwanted memories in the previous week. The level of distress, nowness, reliving, disconnectedness and whether different triggers are associated with the intrusive/unwanted memories of the traumatic event(s) are measured on a 101-point scale (from 0 to 100). Higher scores indicate more intrusive/unwanted memories, higher levels of distress/nowness/reliving/disconnectedness and a greater number of different triggers.

Measure: Intrusion questionnaire - characteristics

Time: Baseline (Day 1), One week and 1, 3, and 6 month follow-up

Description: Self-report measure that assesses subjective distress after a traumatic event (with reference to study event[s]) in the last week. Here we include the intrusion subscale (8 items) and the avoidance subscale (8 items). Items are rated on a 5-point scale ranging from 0 ("not at all") to 4 ("extremely"). Subscale scores are calculated for the Intrusion or Avoidance items summed (ranging from 0 to 32 each). Higher scores indicate worse outcome.

Measure: Impact of Event Scale - Revised (IES-R): Degree of subjective distress of post-trauma intrusion and avoidance symptoms

Time: Baseline (Day 1), One week and 1, 3, and 6 month follow-up

Description: The PCL-5 short version is an 8-item self-report measure that assesses current symptoms of post-traumatic stress disorder in the last month [Baseline (Day 1), 1, 3, and 6 month follow-up] and in the last week (One week). Items are rated on a 5-point scale ranging from 0 ("not at all") to 4 ("extremely"). The PCL-5 short version yields a total symptom severity score which ranges from 0 to 32. Subscale symptom severity scores for DSM-5 symptom cluster B - intrusion symptoms (items 1-2), cluster C - avoidance (items 3-4), cluster D - negative alterations in cognitions and mood (items 5-6), and cluster E - alterations in arousal and reactivity (items 7-8). Higher scores indicate worse severity.

Measure: Posttraumatic Stress Disorder Checklist 5 (PCL-5) short version

Time: Baseline (Day 1), One week and 1, 3, and 6 month follow-up

Description: 2 self-rated items measuring the level of distress and vividness associated with the intrusions (11 point scales from 0 to 10) rated within the diary at baseline (Day 1), week 1 and week 5. High scores indicate higher level of distress/vividness.

Measure: Characteristics of intrusive trauma memories

Time: Baseline (Day 1), Week 1 and week 5

Other Outcomes

Description: Two items measuring the level of concentration disruption associated with the intrusions (11 point scale from 0 to 10) and the duration of disruption (< 1 min, 1-5 min, 5-10 min, 10-30 min, 30-60 min, > 60 min). High scores indicate higher level of concentration disruption and longer duration of disruption.

Measure: Self-rated concentration disruption associated with intrusive memories

Time: Baseline (Day 1), Week 1 and Week 5, 1, 3, and 6 months follow-up

Description: 3 bespoke items including a question on impact on work-related functioning, and one on daily functioning in other areas associated with the intrusions and a question on perceived social support after the traumatic event. All items are rated on an 11-point scale (from 0 "none"; 5 "some"; 10 "extreme/much"). Higher scores indicate higher level of functional impairment/perceived social support.

Measure: Self-rated functioning and social support ratings

Time: Baseline (Day 1), One week, 1, 3, and 6 month follow up

Description: 6 self-report items (11-point scale from 0 to 100) measuring appraisals of intrusions on two subscales: psychological problems (items 1-3) and negative self-evaluations (items 4-6). Items for each subscale will be summed. Possible subscale scores range from 0 - 300, with higher values indicative of worse appraisals.

Measure: Appraisals of intrusive memories

Time: Baseline (Day 1), One week, 1, 3, and 6 month follow-up

Description: Two self rated items: Item 1 measures the extent of being troubled by poor sleep (with reference to study event) on a 5 point scale (from not at all to very much), and item 2 measures the number of nights in the week with sleep problems on a 5 point scale (from 0-1 to 5-7 nights). Each 5-point scale is reverse scored (4 - 0) then summed. Possible total scores range from 0 - 8, with higher values indicative of better sleep.

Measure: Self-rated sleep ratings

Time: Baseline (Day 1), one week and 1, 3, and 6 month follow-up

Description: A single item measuring perceived health status on a seven-point scale (from very good to very bad). The scale is reverse scored. High scores indicate good outcomes.

Measure: Self Rated Health (SRH) rating

Time: Baseline (Day 1), one week, and 1, 3, and 6 month follow-up

Description: 3 free text response field questions (e.g. which type of health care do you work with right now?) at Day 1 and two free text response field questions on whether the work situation changed and if yes, how, at one week, 1, 3, and 6 month follow-up.

Measure: Questions related to work situation

Time: Baseline (Day 1), One week, 1, 3, and 6 month follow-up

Description: 2 bespoke items measuring the total number and the number of full work days on sick leave because of reason for seeking health care. Higher numbers indicate more sick leave.

Measure: Sick leave

Time: Baseline (Day 1), One week, 1, 3, and 6 month follow-up

Description: 3 items measuring the frequency of feeling stressed, pressured, tensed at work during the previous week on a 5-point scale (from "never" to "several times per day"). Item scores are summed. Higher scores indicate higher levels of stress. Further, a single item measuring difficulties to let go of work-related thoughts during leisure time (from "very rarely or never" to "very often or always") and a single question about whether the above mentioned difficulties are because of intrusive memories with a yes/no response.

Measure: Stress and Energy Questionnaire (SEQ) - Stress subscale

Time: Baseline (Day 1), One week, 1, 3, and 6 month follow-up

Description: 9 self-report items (4-point scale from 1 "not at all" to 4 "all the time") measuring symptoms of burnout on three subscales: Exhaustion (items 1-3), disengagement (items 4-6) and inattentiveness (items 7-9). Subscale scores will be the mean of all items per subscale, the total burnout score will be the mean of all items (ranging from 1-4) with higher scores indicative of higher levels of exhaustion/disengagement/inattentiveness/burnout.

Measure: Scale of Work Engagement and Burnout (SWEBO) - Burnout subscale

Time: Baseline (Day 1) and 6 month follow-up

Description: 5 self-report items measuring moral stress at work on a 4-point scale ranging from 1 ("Strongly agree") to 4 ("Strongly disagree"). All items are summed. Potential scores range from 5-20, with higher scores indicative of lower levels of moral stress.

Measure: Moral stress at work

Time: Baseline (Day 1), One week, 1, 3, and 6 month follow-up

Description: A free text response field measuring the occurrence of any health problems since the last contact.

Measure: Adverse events

Time: One week and 1, 3, and 6 month follow-up

Description: A free text response field asking to imagine a future self identity. Then a free text response field to describe a mental image of this identity, 2 items measuring vividness (from 1 "not vivid at all" to 10 "very vivid") and positivity (from 1 "very negative" to 10 "very positive") of that image on a 10-point scale and 1 item measuring the perspective of viewing that mental image ("through own eyes" or "as if seeing oneself") before and after the traumatic event(s). Higher scores on rating scales indicate higher levels of vividness/positivity.

Measure: Future self questionnaire - shortened version

Time: 3 month follow-up

Description: 8 self-report items (5-point scale from 1 to 5) measuring time perspective on three subscales: past perspective (items 3, 5, 7), present perspective (items 1, 8) and future perspective (items 2, 4, 6). Item scores for each subscale will be summed. Higher values indicate higher levels of past/present/future time perspective.

Measure: Time perspective questionnaire

Time: Baseline (Day 1), One week, 1, 3, and 6 month follow-up

Description: 2 free text response field questions (e.g. Are there any specific factors you think have made it easier for you to handle the COVID-19 situation and its consequences?) at Day 1.

Measure: Coping mechanisms

Time: Baseline (Day 1)

Description: 5 item questionnaire (11-point scale from 0 to 10) that rates to what degree the participant finds the intervention credible. High scores indicate greater credibility.

Measure: Credibility/expectancy questionnaire

Time: Day 1

Description: A bespoke manipulation check item measuring self-rated distress during the intervention/control procedure (11-point scale from 0 to 10) at 3 times during the intervention process. Higher scores indicate higher level of distress.

Measure: Subjective Units of Distress (SUDS)

Time: Day 1

Description: 8 bespoke items including questions about study participation e.g. how acceptable was it to do the task? Rated on 11-point scale from 0 (not at all) to 10 (extremely), higher scores indicate higher acceptability; and questions about what has happened since the study with a yes/no response e.g. have you had any psychological or medical treatment since you did the task; and items with a free text response field e.g. do you have any other comments.

Measure: Feedback questionnaire about participation

Time: 1 month follow-up
18 Impact of the Psychiatric Intervention OLAF on the Post Traumatic Disorder in the Relatives of Patients Hospitalized in Intensive Care Unit During the SARS-Cov-2 Pandemic Confinement in France.

The investigators thought that the confinement measure took in France could induce an increase in the post traumatic syndrome in the relative of patient hospitalized in ICU during this period indeed the restricted visit and the limited interaction with ICU team are documented risk factors for PTSD in this population. The investigators designed an intervention in order to prevent the effect of the confinement measures on PTSD in relatives named OLAF. In this research the investigators aimed to study the impact on this intervention on PTSD.

NCT04470869
Conditions
  1. Post Traumatic Stress Disorder
Interventions
  1. Other: Phone call
MeSH:Disease Stress Disorders, Traumatic Stress Disorders, Post-Traumatic

Primary Outcomes

Description: To demonstrate the benefits of a comprehensive family approach (OLAF) on the incidence of PTSD observed in 2 close referents of a patient, 6 months after leaving the intensive care unit, in the context of confinement linked to the SARS pandemic- CoV2.

Measure: incidence of PTSD observed 6 months after patient's discharge from the intensive care unit

Time: Month 6

Secondary Outcomes

Description: The incidence of PTSD 6 months after patient's death in the intensive care unit

Measure: incidence of PTSD observed 6 months after patient's death in the intensive care unit

Time: Month 6

Description: The incidence of PTSD 3 months after the death or discharge from the intensive care unit

Measure: PTSD incidence at month 3

Time: Month 3

Description: The incidence of PTSD 12 months after the death or discharge from the intensive care unit

Measure: PTSD incidence at month 12

Time: Month 12

Description: The incidence of symptoms of anxiety and / or depression 3 months after death or discharge from the intensive care unit

Measure: Symptoms incidence at month 3

Time: Month 3

Description: The incidence of symptoms of anxiety and / or depression 6 months after death or discharge from the intensive care unit

Measure: Symptoms incidence at month 6

Time: Month 6

Description: The incidence of symptoms of anxiety and / or depression 12 months after death or discharge from the intensive care unit

Measure: Symptoms incidence at month 12

Time: Month 12

Description: The incidence of persistent complicated grief 3 months after death in intensive care

Measure: incidence of persistent complicated grief at month 3

Time: Month 3

Description: The incidence of persistent complicated grief 6 months after death in intensive care

Measure: incidence of persistent complicated grief at month 6

Time: Month 6

Description: The incidence of persistent complicated grief 12 months after death in intensive care

Measure: incidence of persistent complicated grief at month 12

Time: Month 12
19 Psychological Distress Symptoms in Family Members of Patients With COVID-19 Respiratory Failure in Intensive Care Units

Coronavirus disease 2019 (COVID-19) is a novel infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). This syndrome has been associated with high mortality, estimated to be about 1.7% of all infected in the US, though in those who develop acute respiratory distress syndrome (ARDS) in the context of the infection, mortality rates appear to be much higher, perhaps up to 70%. To avoid transmission of the virus, patient isolation has become the standard of care, with many hospitals eliminating visitors of any type, and particularly eliminating visitation to patients infected with COVID-19. These necessary, but restrictive, measures add stress to the ICU and particularly to the family members who are not only left with fear, but also many unanswered questions. In contrast to the Society of Critical Care Guidelines (SCCM) which recommend family engagement in the ICU and recent data from this study team which suggests engaging families in end-of-life situations reduces symptoms of Post-Traumatic Stress Disorder (PTSD) in family members, family members are now unable to say good-bye and unable to provide support to their loved-one throughout the process of the patients' ICU stay. The study hypothesizes is that these restrictive visiting regulations will increase rates of Post-intensive care syndrome- family (PICS-F) which includes symptoms of PTSD, depression, and anxiety and aim to evaluate for factors that either exacerbate these symptoms or protect from them.

NCT04476914
Conditions
  1. Respiratory Failure
  2. SARS-CoV 2
  3. Corona Virus Infection
  4. Post Intensive Care Unit Syndrome
  5. Family Members
  6. Post Traumatic Stress Disorder
  7. Anxiety
  8. Depression
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Respiratory Insufficiency Stress Disorders, Traumatic Stress Disorders, Post-Traumatic

Primary Outcomes

Description: Using Impact of Events Scale-Revised-6 , family members will be screened for symptoms of PTSD. Scale returns scores of 0-24, with higher scores indicating more likely to have symptoms of PTSD

Measure: Symptoms of Post-Traumatic Stress Disorder (PTSD)

Time: 90-120 days after admission of patient to the ICU

Secondary Outcomes

Description: Using the Hospital Anxiety and Depression Score, family members will be screened for symptoms of anxiety. The HADS anxiety scale is scored between 0 and 21, with higher scores indicating more likely to have symptoms of anxiety

Measure: Symptoms of Anxiety

Time: 90-120 days after admission of patient to the ICU

Description: Using the Hospital Anxiety and Depression Score, family members will be screened for symptoms of Depression. The HADS depression scale is scored between 0 and 21, with higher scores indicating more likely to have symptoms of depression

Measure: Symptoms of Depression

Time: 90-120 days after admission of patient to the ICU

Description: Using preselected questions from the Family Satisfaction in the ICU-27 questionnaire, we will survey families to evaluate their satisfaction with communication and decision making. Higher scores will indicate more satisfication

Measure: Family Satisfaction with Communication and Decision Making

Time: 90-120 days after admission of patient to the ICU
20 Relieving the Burden of Psychological Symptoms Among Families of Critically Ill Patients With COVID-19

Families of patients in Intensive Care Units (ICUs) are at increased risk for developing psychological symptoms that can last for months after the patient is discharged. These symptoms can have significant impact on both the patient and family member's quality of life. The investigators have found that families of patients admitted to the Rush University Medical Center ICU during to the COVID-19 pandemic were more likely to develop clinically significant psychological symptoms than families of patients admitted prior to the COVID-19 pandemic. The investigators suspect that this finding is due in part to the hospital-wide no visitation policy that altered our standard communication practices and may have prevented families from being active participants in the patient's medical care. The goals of this project are 1) to determine the prevalence of psychological disorders among families of COVID-19 patients after ICU discharge 2) to determine the characteristics of ICU care that were associated with the development of psychological disorders among family members and 3) to pilot a program in which families with psychological disorders after ICU discharge receive therapy from mental health professionals.

NCT04501445
Conditions
  1. Family Members
  2. Post Intensive Care Unit Syndrome
  3. Post Traumatic Stress Disorder
Interventions
  1. Behavioral: Written Summary of Rounds
MeSH:Stress Disorders, Traumatic Stress Disorders, Post-Traumatic

Primary Outcomes

Description: Score on Impact of Events Scale Revised (IES-R) questionnaire. 22 questions. Score 0-88 with higher scores indicating more stress.

Measure: Symptoms of Post-Traumatic Stress Disorder (PTSD) initial

Time: Measured once upon enrollment

Description: Score on Hospital Anxiety and Depression Scale (HADS). Total score 0-21 for anxiety (7 questions) and 0-21 for depression (7 questions). Higher scores indicate greater symptom burden.

Measure: Symptoms of Anxiety and Depression initial

Time: Measured once upon enrollment

Secondary Outcomes

Description: Score on the Critical Care Family Needs Inventory (CCFNI) questionnaire. 14 questions. Total score range 14-56 with lower scores indicating better satisfaction.

Measure: Surrogate Satisfaction with the Patient's ICU Care:

Time: Measured once upon enrollment

Description: Score on Hospital Anxiety and Depression Scale (HADS). Total score 0-21 for anxiety (7 questions) and 0-21 for depression (7 questions). Higher scores indicate greater symptom burden.

Measure: Symptoms of Post-Traumatic Stress Disorder (PTSD) final

Time: Measured after behavioral intervention (6-12 weeks after enrollment)

Description: Score on Hospital Anxiety and Depression Scale (HADS). Total score 0-21 for anxiety (7 questions) and 0-21 for depression (7 questions). Higher scores indicate greater symptom burden.

Measure: Symptoms of Anxiety and Depression final

Time: Measured after behavioral intervention (6-12 weeks after enrollment)

Description: Qualitative analysis of phone interview to determine the presence and reason(s) for psychological symptoms

Measure: Interview initial

Time: Measured once upon enrollment

Description: Qualitative analysis of phone interview to determine the presence and reason(s) for psychological symptoms

Measure: Interview final

Time: Measured after behavioral intervention (6-12 weeks after enrollment)
21 Burnout and Distress preventiOn With caNnabidiol in Front-line Health Care workerS deAling (Bonsai Study) wIth COVID-19: a Randomised Controlled Trial

The objective of this work is to monitor the level of stress and overload of a group of front-line health workers (physicians, nurses and physiotherapists) who will participate in the care of patients with COVID-19 at Hospital das Clínicas in Ribeirão Preto and its Emergency Unit (HCRP), for four weeks, and evaluate the cannabidiol - CBD's effectiveness in reducing stress for those who wish to use it.

NCT04504877
Conditions
  1. Covid19
  2. Burn Out
  3. Post Traumatic Stress Disorder
Interventions
  1. Drug: Cannabidiol
MeSH:Stress Disorders, Traumatic Stress Disorders, Post-Traumatic

Primary Outcomes

Description: To assess the emotional exhaustion dimension of the burnout syndrome, based on nine items, scored from 0 ("never") to 6 ("every day")

Measure: aMBI-HSS: Abbreviated Maslach Burnout Inventory - Human Services Survey

Time: Through study completion, over time during the study period (day 0-28)

Secondary Outcomes

Description: brief measure for assessing generalized anxiety disorder

Measure: Brief measure for assessing generalized anxiety disorder: The GAD-7

Time: Through study completion, over time during the study period (day 0-28)

Description: Evaluate depressive symptoms o

Measure: PHQ-9: Patient´s Health Questionnaire-9

Time: Through study completion, over time during the study period (day 0-28)

Description: Laboratory parameters, including the change in proinflammatory cytokine concentrations

Measure: Change in proinflammatory cytokine concentration

Time: Through study completion, over time during the study period (day 0-28)

Description: Occurrence of side effects

Measure: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

Time: Through study completion, over time during the study period (day 0-28)

Description: It is a self-report measure widely used to assess PTSD symptoms, according to the DSM-5 criteria. The reduced version of this instrument will be used (8 items)

Measure: Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)

Time: Through study completion, over time during the study period (day 0-28)
22 Psychological Impact of COVID-19 Outbreak on Caregivers Involved in Intensive Care Unit Patient Management: Impact on the Occurrence of Post-traumatic Stress Disorder, Anxiety, Depression and Burn Out Syndrome

Based on the experience of previous pandemics, countries reacted by applying different upgrade strategies to prevent or delay the widespread of the disease. Therefore, measures such as border closure, school closure, restrict social gathering (even shutdown of workplaces), limit population movements, and confinement meaning quarantines at the scale of cities or regions. In public hospitals, several measures have been decided to concentrate the power of care on potential wave of admissions of patients with severe forms of Covid-19. In this purpose, the number of available beds in Intensive Care Units (ICU) has been increased by two-fold and scheduled non-emergency surgical procedure have been cancelled. That means: 1. For the most severe patients, new personals (physician such as anesthesiologists, nurses of other units) have been transferred in ICUs. 2. For the less severe patients, personals of non-busy units have been transferred in busier ones. All these measures lead to major daily-life change sets that could be stressful. In the general population, it has been well documented that quarantine or confinement or isolation could lead to the occurrence of Post-Traumatic Stress Disorder (PTSD) syndrome in about 30% overall population. Importantly, high depressive symptoms have been reported in 9% of hospital staff. Numerous symptoms have been reported after quarantine or isolation such as emotional disturbance, depression, stress, low mood, irritability, insomnia, and post-traumatic stress symptoms. In hospital setting, few studies have been performed for assessing the psychological impact of quarantine and isolation. However, two studies reported a high prevalence of burn-out syndrome (BOS) in ICU physician and PTSD syndrome and depression in ICU nurses. As the consequences of all the measures decided and applied during Covid-19 pandemic could be important on caregivers, the present study primarily aims at assessing the prevalence of PTSD syndrome in a large population of caregivers implied or not in Intensive Care Units. The secondary objective were 1) to assess the prevalence of severe depression and anxiety and BOS 2) to isolate potential factors associated with PTSD, severe depression, anxiety or BOS.

NCT04511780
Conditions
  1. Critical Illness
  2. Covid19
  3. Stress Disorders, Post-Traumatic
Interventions
  1. Other: questionnaire filling
MeSH:Critical Illness Stress Disorders, Traumatic Stress Disorders, Post-Traumatic

Primary Outcomes

Description: PCL - 5 (Post-Traumatic Stress Disorder Checklist Scale, version DSM-5)

Measure: Post-Traumatic Stress Disorder

Time: 3-6 month after the Covid-19 outbreak

Secondary Outcomes

Description: HADS scale (Hospital Anxiety and Depression Scale)

Measure: anxiety and depression

Time: 3-6 month after the Covid-19 outbreak

Description: Score MBI (Burn out syndrome)

Measure: Burn out

Time: 3-6 month after the Covid-19 outbreak
23 Neural Mechanisms of Mindfulness-based Cognitive Therapy (MBCT) for Posttraumatic Stress Disorder (PTSD) - COVID Related Substudy

This clinical trial is a sub-study to treat participants that were not eligible in the main study (HUM00152509/NCT03874793) to receive MBCT or MRT in hard hit COVID-19 areas with trauma history and current COVID-related distress. The purpose of this treatment-only sub-study is to see how eligible participants with life history of any trauma and are currently experiencing elevated COVID-related stress are affected by two different PTSD therapies involving Mind-Body practices; Mindfulness based Cognitive Therapy (MBCT) and Muscle Relaxation Therapy. The targeted individuals will reside in areas (Washtenaw, Wayne, and Oakland counties in Michigan, etc.) that have been affected by COVID-19. Participants will have assessments before and after 8 weeks of therapy (remote MBCT or MRT).

NCT04540939
Conditions
  1. Trauma
Interventions
  1. Behavioral: Mindfulness-Based Cognitive Therapy
  2. Behavioral: Muscle Relaxation Therapy
MeSH:Stress Disorders, Post-Traumatic

Primary Outcomes

Description: This Anxiety-Adult measure 7-item PROMIS Anxiety Short Form assesses the pure domain of anxiety in individuals age 18 and older. The participants will select how often they have been bothered by symptoms during the past 7 days from 1=never to 5=always (the higher the score the more anxiety).

Measure: Patient-Reported Outcomes Measurement Information System (PROMIS-adult short form level 2) Anxiety survey

Time: up to 8 weeks

Description: The PSWQ is a well-validated self-administered, 16-item, Likert-type scale designed to measure worry. Possible range of scores is 16-80 with the algorithm of Total scores: 16-34 Low Worry, 35-59 Moderate, and 60-80 High Worry.

Measure: Penn State Worry Questionnaire (PSWQ-16) Worry survey

Time: up to 8 weeks

Description: This is an 8 question survey where participants will select answers of 1= Never to 5= always. The higher the score the greater severity of depression.

Measure: PROMIS (adult short form) Emotional Depression survey

Time: up to 8 weeks

Description: This is a 12-item measure that assesses therapy clients' perception of working alliance with their therapists, developed by Adam Horvath with 3 factors of shared goals, tasks, and personal bond / regard. The participants select from Seldom= 1, Sometimes=2, Fairly often =3, Very often = 4, and Always = 5. The higher the score the higher working alliance.

Measure: Working Alliance Inventory- short revised (WAI-SR)

Time: up to 8 weeks

Secondary Outcomes

Description: This Anxiety-Adult measure 7-item PROMIS Anxiety Short Form assesses the pure domain of anxiety in individuals age 18 and older. The participants will select how often they have been bothered by symptoms during the past 7 days from 1=never to 5=always (the higher the score the more anxiety). This will look at the group differences between MBCT and PMR.

Measure: Patient-Reported Outcomes Measurement Information System (PROMIS-adult short form level 2) Anxiety survey group differences (MBCT and PMR)

Time: up to 8 weeks

Description: The PSWQ is a well-validated self-administered, 16-item, Likert-type scale designed to measure worry. Possible range of scores is 16-80 with the algorithm of Total scores: 16-34 Low Worry, 35-59 Moderate, and 60-80 High Worry. This will look at the group differences between MBCT and PMR.

Measure: Penn State Worry Questionnaire (PSWQ-16) Worry survey group differences (MBCT and PMR)

Time: up to 8 weeks

Description: This is an 8 question survey where participants will select answers of 1= Never to 5= always. The higher the score the greater severity of depression. This will look at the group differences between MBCT and PMR.

Measure: PROMIS (adult short form) Emotional Depression survey group differences (MBCT and PMR)

Time: up to 8 weeks

Description: This is a 12-item measure that assesses therapy clients' perception of working alliance with their therapists, developed by Adam Horvath with 3 factors of shared goals, tasks, and personal bond / regard. The participants select from Seldom= 1, Sometimes=2, Fairly often =3, Very often = 4, and Always = 5. The higher the score the higher working alliance.This will look at the group differences between MBCT and PMR.

Measure: Working Alliance Inventory- short revised (WAI-SR) group differences (MBCT and PMR)

Time: up to 8 weeks
24 Prevalence and Development of Post-traumatic Stress Disorder and Anxiety and Depressive Symptoms Among AP-HP Staff During the Covid-19 Epidemic

The epidemic of coronavirus induces a major influx of patients implying a rapid modification of the organizations, a work overload and a significant stress for the care teams and supports of the hospitals of the Assistance Publique - Hôpitaux de Paris (AP-HP) . To this is added the impact on each professional of the large number of very severe patients to be treated, of death and the anxiety of contamination, reinforced by the actual cases of staff themselves sick. Emergency phone numbers for professionals in the event of psychological suffering were quickly put in place at the AP-HP and Hospitals level. The objective of this study is to assess the psychopathological and psycho-traumatic consequences of this exceptional situation on the staff, during the epidemic and at a distance from it, in order to be able to target the solutions to be implemented. Hypothesis is that some personnel may develop one or more of the following disorders: adjustment disorder or other anxiety disorder, acute stress disorder, post-traumatic stress disorder (PTSD), and depressive episodes as defined in the DSM-5. This study also aimes to assess effect of support measures put in place, by comparing the evolution of those who benefited from those who did not use them, as well as the risk factors specific. The results will make it possible to have an estimate of the percentage of people who may require specific support, and to identify the staff most at risk, and thus predict the importance of the circuits and structures for support of staff which will be necessary in the short and long term. The main anticipated risk factors are: being a nurse, having a low number of years of professional experience, and being on the front line of care for affected patients.

NCT04558437
Conditions
  1. Post Traumatic Stress Disorder (PTSD)
  2. Anxiety
  3. Depression
  4. Epidemic Disease
  5. COVID19
Interventions
  1. Other: Questionnaire
MeSH:Stress Disorders, Traumatic Stress Disorders, Post-Traumatic

Primary Outcomes

Description: Rate of respondents with a PTSD defined as score higher or equal to 32 for PCL-5 (Post-Traumatic Stress Disorder Checklist Scale, version DSM-5) at, at least, one of the three measures (inclusion, M3 or M6)

Measure: Prevalence of PTSD among APHP staff during the COVID-19 epidemic and at a distance (inclusion, 3 months or 6 months).

Time: 6 months

Secondary Outcomes

Description: Rate of respondents with an Anxiety Disorder defined as score higher or equal to 8 for the HAD-A subscale (Hospital Anxiety and Depression - Anxiety subscale) independently at each measure (inclusion, M3 and M6)

Measure: Prevalence of Anxiety Disorder among APHP staff during the COVID-19 epidemic and at a distance (inclusion, 3 months and 6 months).

Time: baseline, 3 months and 6 months

Description: Rate of respondents with a Depressive Disorder defined as score higher or equal to 8 for the HAD-D subscale (Hospital Anxiety and Depression - Depression subscale) independently at each measure (inclusion, M3 and M6)

Measure: Prevalence of Depressive Disorder among APHP staff during the COVID-19 epidemic and at a distance (inclusion, M3 and M6).

Time: baseline, 3 months and 6 months
25 Symptoms of Depression, Stress and Burnout, and Long-term Psychological Impact in Health Care Professionals Exposed to the Novel Coronavirus Disease 2019 Outbreak (HARD-COVID-19 - Health cAre woRkers exposeD to covID-19)

Hospital health workers involved in the coronavirus epidemic are facing several challenges such as direct exposure and involvement in the resolution of major public health emergencies, exposure to potentially fatal contamination, physical exhaustion , unadjusted work organizations, the unusual number of deaths among patients, colleagues and close relatives, and significant ethical challenges in decision-making. Preliminary data suggests that frontline and lay professionals suffer from different types of psychological distress. These data highlight the importance of screening for psychological distress in response to the scale of the pandemic and the provision of targeted psychological interventions, such as Eye Movement Desensitization and Reprocessing (EMDR, desensitization and neuro-emotional integration by eye movements), to improve the psychological well-being of healthcare workers exposed to COVID-19. This project is both a cohort study with the proposal of a randomized trial to evaluate an intervention adapted to the exceptional circumstances of the crisis. As such, it is designed as Trial(s) Within Cohort design (TWIC).

NCT04570202
Conditions
  1. Depression
  2. Burnout, Professional
  3. Post Traumatic Stress Disorder
Interventions
  1. Behavioral: EMDR
MeSH:Burnout, Professional Depression Depressive Disorder Stress Disorders, Traumatic Stress Disorders, Post-Traumatic Burnout, Psychological
HPO:Depressivity

Primary Outcomes

Description: This study is investigating three different conditions (PTSD, Depression and Burnout) each assessed with its own primary endpoint. Thus, the trial will have three primary endpoints. Change over a 6 months period in symptoms of PTSD measured by the Post-Traumatic Stress Disorder Checklist Scale for Diagnostic and Statistical Manual of mental disorders fifth edition ((DSM-5), PCL-5). The PCL-5 score is on a scale from 0 to 80. The higher the score, the higher the level of PTSD symptoms are.

Measure: Efficacy on symptoms of Post-Traumatic Stress Disorder

Time: From inclusion to 6 months after inclusion

Description: Change over a 6 months period in symptoms of Burnout measured by the Professional Quality Of Life questionnaire (ProQOL). The ProQOL score is on a scale from 30 to 150. The higher the score, the higher the level of Burnout symptoms are.

Measure: Efficacy on symptoms of Burnout

Time: From inclusion to 6 months after inclusion

Description: Change over a 6 months period in symptoms of depression measured by the Patient Health Questionnaire (PHQ-9). The PHQ-9 score is on a scale from 0 to 27. The higher the score, the higher the level of depression symptoms are.

Measure: Efficacy on symptoms of Depression

Time: From inclusion to 6 months after inclusion

Secondary Outcomes

Description: Change over a 3 months period in symptoms of PTSD measured by the Post-Traumatic Stress Disorder Checklist Scale for Diagnostic and Statistical Manual of mental disorders fifth edition ((DSM-5), PCL-5). The PCL-5 score is on a scale from 0 to 80. The higher the score, the higher the level of PTSD symptoms are.

Measure: Short-term efficacy on symptoms of PTSD

Time: From inclusion to 3 months after inclusion

Description: Change over a 3 months period in symptoms of Burnout measured by the Professional Quality Of Life questionnaire (ProQOL). The ProQOL score is on a scale from 30 to 150. The higher the score, the higher the level of Burnout symptoms are.

Measure: Short-term efficacy on symptoms of Burnout

Time: From inclusion to 3 months after inclusion

Description: Change over a 3 months period in symptoms of depression measured by the Patient Health Questionnaire (PHQ-9). The PHQ-9 score is on a scale from 0 to 27. The higher the score, the higher the level of depression symptoms are.

Measure: Short-term efficacy on symptoms of Depression

Time: From inclusion to 3 months after inclusion

Description: Change over a 12 months period in symptoms of PTSD measured by the Post-Traumatic Stress Disorder Checklist Scale for Diagnostic and Statistical Manual of mental disorders fifth edition ((DSM-5), PCL-5) for the participants who will be enrolled in the trial at M0 of the cohort. The PCL-5 score is on a scale from 0 to 80. The higher the score, the higher the level of PTSD symptoms are.

Measure: Long-term efficacy on symptoms of PTSD

Time: From inclusion to 12 months after inclusion

Description: Change over a 12 months period in symptoms of Burnout measured by the Professional Quality Of Life questionnaire (ProQOL) for the participants who will be enrolled in the trial at M0 of the cohort. The ProQOL score is on a scale from 30 to 150. The higher the score, the higher the level of Burnout symptoms are.

Measure: Long-term efficacy on symptoms of Burnout

Time: From inclusion to 12 months after inclusion

Description: Change over a 12 months period in symptoms of depression measured by the Patient Health Questionnaire (PHQ-9) for the participants who will be enrolled in the trial at M0 of the cohort. The PHQ-9 score is on a scale from 0 to 27. The higher the score, the higher the level of depression symptoms are.

Measure: Long-term efficacy on symptoms of Depression

Time: From inclusion to 12 months after inclusion

Description: Change over a 6 months period in anxiety measured by the Generalized Anxiety Disorder-7 questionnaire (GAD-7). The GAD-7 score is on a scale from 0 to 21. The higher the score, the higher the level of anxiety symptoms are.

Measure: Efficacy on symptoms of Anxiety

Time: From inclusion to 6 months after inclusion

Description: Change over a 12 months period in anxiety measured by the Generalized Anxiety Disorder-7 questionnaire (GAD-7) for the participants who will be enrolled in the trial at M0 of the cohort. The GAD-7 score is on a scale from 0 to 21. The higher the score, the higher the level of anxiety symptoms are.

Measure: Long-term efficacy on symptoms of Anxiety

Time: From inclusion to 12 months after inclusion

Description: Number of suicide attempts over a 6-month period from baseline

Measure: Efficacy on suicide attempts

Time: From inclusion to 6 months after inclusion

Other Outcomes

Description: Changes in the level of suicidal ideation over a 6 months period from baseline measured by Visual Analog Scale (VAS). The VAS is on a scale from 0 to 10. The higher the VAS score, the higher suicidal ideation level is.

Measure: Efficacy on suicidal ideation

Time: From inclusion to 6 months after inclusion

Description: Changes in the level of suicidal ideation over a 12 months period from baseline measured by Visual Analog Scale (VAS) for the participants who are enrolled in the trial at M0 of the cohort. The VAS is on a scale from 0 to 10. The higher the VAS score, the higher suicidal ideation level is.

Measure: Long-term efficacy on suicidal ideation

Time: From inclusion to 12 months after inclusion

Description: Change in the impact of health on functioning (Role Emotional (RE) subdomain of the MOS Short Form-36 health survey v1.3 (SF-36)) over a 6 months period from baseline. The RE score is on a scale from 0 to 100. The higher the score, the better Role Emotional is.

Measure: Efficacy on the impact of health on functioning: Role Emotional

Time: From inclusion to 6 months after inclusion

Description: Change in the impact of health on functioning (Role Emotional (RE) subdomain of the MOS Short Form-36 health survey v1.3 (SF-36)) over a 12 months period from baseline for the participants who are enrolled in the trial at M0 of the cohort. The RE score is on a scale from 0 to 100. The higher the score, the better Role Emotional is.

Measure: Long-term efficacy on the impact of health on functioning: Role Emotional

Time: From inclusion to 12 months after inclusion

Description: Change in the impact of health on functioning (Role Physical (RP) subdomain of the MOS Short Form-36 health survey v1.3 (SF-36)) over a 6 months period from baseline. The RP score is on a scale from 0 to 100. The higher the score, the better Role Physical is.

Measure: Efficacy on the impact of health on functioning: Role Physical

Time: From inclusion to 6 months after inclusion

Description: Change in the impact of health on functioning (Role Physical (RP) subdomain of the MOS Short Form-36 health survey v1.3 (SF-36)) over a 12 months period from baseline for the participants who are enrolled in the trial at M0 of the cohort. The RP score is on a scale from 0 to 100. The higher the score, the better Role Physical is.

Measure: Long-term efficacy on the impact of health on functioning: Role Physical

Time: From inclusion to 12 months after inclusion

Description: Evolution of substance use over 6 months

Measure: Substance use

Time: From inclusion to 6 months after inclusion

Description: Evolution of substance use over 12 months for the participants who are enrolled in the trial at M0 of the cohort

Measure: Long-term substance use

Time: From inclusion to 12 months after inclusion

Description: Evolution of medication use over 6 months

Measure: Medication use

Time: From inclusion to 6 months after inclusion

Description: Evolution of medication use over 12 months for the participants who are enrolled in the trial at M0 of the cohort

Measure: Long-term medication use

Time: From inclusion to 12 months after inclusion

Description: Number of consultations of health professionals within the period of follow-up (general practitioner, psychiatrist, psychotherapist, psychologist, professionals who are practicing alternative medicines); Occurrence of EMDR therapy within the control group; Number of visits at the emergency unit of a hospital; Number of nights spent in hospital as a patient (short-term); Number of nights spent in rehabilitation facilities as a patient.

Measure: Health care utilization

Time: From inclusion to 6 months after inclusion

Description: Number of consultations of health professionals within the period of follow-up (general practitioner, psychiatrist, psychotherapist, psychologist, professionals who are practicing alternative medicines); Occurrence of EMDR therapy within the control group; Number of visits at the emergency unit of a hospital; Number of nights spent in hospital as a patient (short-term); Number of nights spent in rehabilitation facilities as a patient. For the participants who are enrolled in the trial at M0 of the cohort

Measure: Long-term health care utilization

Time: From inclusion to 12 months after inclusion

Description: Proportion of those who will be offered EMDR and will actually receive EMDR

Measure: Acceptability of EMDR in the EMDR group

Time: From inclusion to 12 months after inclusion

Description: Number of sessions attended over the total planned number

Measure: Compliance in the EMDR group

Time: From inclusion to 12 months after inclusion
26 Impact of COVID-19 Pandemic in Perinatal Mental Health

Introduction: Coronavirus disease 2019 (COVID-19) is a new pathology, declared a public health emergency by the World Health Organization, which can have negative consequences for pregnant women and their newborns. It is estimated that 1 in 5 women will develop a mental illness in the perinatal period. COVID-19 pandemic has been associated with anxiety and depression in the population. The current pandemic is a unique stressor with potentially wide-ranging consequences in the perinatal period, but little is known about the impact of COVID-19 on perinatal mental health. Thus, the objective of this study is to explore the experiences of pregnant and new mothers during the current pandemic, particularly its impact on perinatal mental health (including depression, anxiety, PTSD and psychological distress). Methods: The study design is a prospective observational study, with a baseline assessment and three follow-ups: one month; three months; and six months post baseline. This international study will be carried out in 11 European countries (Albania, Bulgaria, Cyprus, France, Greece, Israel, Malta, Portugal, Spain, Turkey, United Kingdom) Chile and Brazil. The study population will comprise pregnant women and new mothers with an infant under six months of age, covering a broad range of women across the perinatal period. Ethics and dissemination: The study and handling of the data will follow all national required data protection standards. Each researcher (or team of researchers) involved will submit the project to their local ethical committee before starting the project. Results from the project will be disseminated in peer reviewed journals and international conferences.

NCT04595123
Conditions
  1. Post Traumatic Stress Disorder
  2. Depression
  3. Anxiety
  4. Psychological Distress
MeSH:Depression Stress Disorders, Traumatic Stress Disorders, Post-Traumatic

Primary Outcomes

Description: Number of depressive symptoms evaluated by Edinburgh Postnatal Depression Scale (EPDS). Scores range from 0 to 30. Higher scores mean worse outcome

Measure: Depressive symptoms

Time: June 2020- June 2021

Description: Number of Post-Traumatic Stress Disorders (PTSD) symptoms evaluated by check list of DSM-5. HIgher number of symptoms mean worse outcomes

Measure: Posttraumatic Stress Disorder

Time: June 2020- June 2021

Description: Number of anxiety symptoms evaluated by General Anxiety Disorder questionnaire (GAD 7). Scores range from 0 to 21. Higher scores mean worse outcomes.

Measure: Anxiety symptoms

Time: June 2020- June 2021
27 Effect of COVID19-related COntainment in ChildreN

The current pandemic situation (SRAS COV2) is an unprecedented event and a source of stress potentially aggravated by containment. The Child Revised Impact Event Scale (CRIES-13) was evaluated in children 8 years or older in survivors of traumatic events, flood, stay in intensive care, or war (Bosnia). In this study CRIES-13 will be used to determine the prevalence of precursor signs of post-traumatic stress in children aged 8 to 15 confined between March 17, 2020 and May 2020

NCT04615195
Conditions
  1. Post Traumatic Stress Disorder
Interventions
  1. Other: cries 13 questionnaire
MeSH:Stress Disorders, Traumatic Stress Disorders, Post-Traumatic

Primary Outcomes

Description: Using a simple score (Child Revised Impact of Event Scale (CRIES-13)), determine the prevalence of precursor signs of post-traumatic stress in children aged 8 to 15 confined between March 17, 2020 and May 2020

Measure: Signs of post traumatic stress disorder

Time: 1 month
28 A Brief Phased Two-Step Intervention for Treating General Psychological Distress, PTSD and Co-Morbidities in Healthcare Workers Consequent to the COVID-19 Pandemic

It is expected that large numbers of healthcare workers will experience a broad range of psychological reactions and symptoms including anxiety, depression, moral distress, and trauma symptoms that will cause both significant suffering as well as occupational and social impairment. The purpose of this study is to find interventions which are helpful in treating psychological distress in healthcare workers caring for COVID-19 patients. There are two phases of the study. All participants will take part in Phase I, which consists of 4 sessions over a two-week period of either a narrative writing intervention or a medical music intervention. Participants will be randomly assigned to the narrative writing intervention or medical music intervention. After Phase I, participants will be re-assessed. Healthcare workers who meet criteria for PTSD will be given the option to participate in Phase II of the study, in which they will be offered a choice between one of two evidence-based treatments for PTSD: Interpersonal Therapy (IPT) or Exposure Therapy (ET). Both treatments are comprised of ten 75-minute sessions scheduled twice weekly. Participants will be allowed to choose a preferred treatment in Phase II. After Phase II participants will complete a final assessment concluding the study. All interventions will be offered using distance technology.

NCT04626050
Conditions
  1. Post-traumatic Stress Disorder
  2. Moral Injury
Interventions
  1. Behavioral: Medical Music
  2. Behavioral: Narrative Writing
  3. Behavioral: Prolonged Exposure Therapy
  4. Behavioral: Interpersonal Psychotherapy
MeSH:Stress Disorders, Traumatic Stress Disorders, Post-Traumatic

Primary Outcomes

Description: Feasibility assessment will include recruitment defined as number of individuals interested in the intervention.

Measure: Feasibility Indicator: Recruitment (Phase I)

Time: Baseline

Description: Feasibility assessment will include: recruitment defined as number of individuals interested in the intervention.

Measure: Feasibility Indicator: Recruitment (Phase II)

Time: Post-Phase I Assessment at week 2

Description: Feasibility assessment will include enrollment defined as number of participants signing the informed consent form.

Measure: Feasibility Indicator: Enrollment (Phase I)

Time: Baseline

Description: Feasibility assessment will include enrollment defined as number of individuals beginning phase II.

Measure: Feasibility Indicator: Enrollment (Phase II)

Time: Post-Phase I Assessment at approximately week 2

Description: Feasibility assessment will include retention defined as the number of participants completing the full course of Phase I interventions.

Measure: Feasibility Indicator: Retention (Phase I)

Time: Post-Phase I Assessment at approximately week 2

Description: Feasibility assessment will include retention defined as the number of participants completing the full couse of Phase II interventions.

Measure: Feasibility Indicator: Retention (Phase II)

Time: Post-Phase II Assessment at approximately week 7

Description: Acceptability and treatment satisfaction will be rated with a Likert scale.

Measure: Acceptability Indicator: Satisfaction (Phase I)

Time: Post-Phase I Assessment at approximately week 2

Description: Acceptability and treatment satisfaction will be rated with a Likert scale.

Measure: Acceptability Indicator: Satisfaction (Phase II)

Time: Post-Phase II Assessment at approximately week 7

Description: Change in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Score. Total Scores range from 0-80. Higher scores indicate greater symptom severity.

Measure: Preliminary Efficacy as Measured by Change in Clinician-Administered PTSD Scale Score (Phase I)

Time: Start of Phase I to approximately 2 weeks

Description: Change in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Score. Total Scores range from 0-80. Higher scores indicate greater symptom severity.

Measure: Preliminary Efficacy as Measured by Change in Clinician-Administered PTSD Scale Score (Phase II)

Time: Start of Phase II to approximately 5 weeks

Secondary Outcomes

Description: Scored between 0-21: Cut offs: 0-4 = None 5-9 = Mild anxiety 10-14 = Moderate anxiety 15-21 = Severe anxiety Higher scores indicate greater symptom severity.

Measure: Change in Anxiety Symptoms measured by the Generalized Anxiety Disorder 7-Item Scale (Phase I)

Time: Start of Phase I to approximately 2 weeks

Description: Scored between 0-21: Cut offs: 0-4 = None 5-9 = Mild anxiety 10-14 = Moderate anxiety 15-21 = Severe anxiety Higher scores indicate greater symptom severity.

Measure: Change in Anxiety Symptoms measured by the Generalized Anxiety Disorder 7-Item Scale (Phase II)

Time: Start of Phase II to approximately 5 weeks

Description: 21-item self-report measure. Scored between 0-63. Higher scores indicate greater symptom severity.

Measure: Change in Depressive Symptoms measured by the Beck Depression Inventory-II (Phase I)

Time: Start of Phase I to approximately 2 weeks

Description: 21-item self-report measure. Scored between 0-63. Higher scores indicate greater symptom severity.

Measure: Change in Depressive Symptoms measured by the Beck Depression Inventory-II (Phase II)

Time: Start of Phase II to approximately 5 weeks

Description: 24 item self-report measure. 19 questions are evaluated. Each item in the scale is rated between 0 (no distress) and 3 (serious distress). The total PSQI score ranges from 0-21. Sleep quality of the patients with a total score of 5 and below is considered "good". A score of greater than 5 refers to poor sleep quality.

Measure: Change in score on the Pittsburgh Sleep Quality Index (PSQI) (Phase I)

Time: Start of Phase I to approximately 2 weeks

Description: 24 item self-report measure. 19 questions are evaluated. Each item in the scale is rated between 0 (no distress) and 3 (serious distress). The total PSQI score ranges from 0-21. Sleep quality of the patients with a total score of 5 and below is considered "good". A score of greater than 5 refers to poor sleep quality.

Measure: Change in score on the Pittsburgh Sleep Quality Index (PSQI) (Phase II)

Time: Start of Phase II to approximately 5 weeks

Description: 21 item self-report measure measuring moral distress (the emotional state that arises from a situation when an individual feels that the ethically correct action to take is different from what he/she is tasked with doing). Score range is 0-336. Higher scores indicate greater moral distress.

Measure: Change in score on the Moral Distress Scale (Phase I)

Time: Start of Phase I to approximately 2 weeks

Description: 21 item self-report measure measuring moral distress (the emotional state that arises from a situation when an individual feels that the ethically correct action to take is different from what he/she is tasked with doing). Score range is 0-336. Higher scores indicate greater moral distress.

Measure: Change in score on the Moral Distress Scale (Phase II)

Time: Start of Phase II to approximately 5 weeks

Description: 11 item self-report measure that measures moral injury. Statements related to distress or feelings of betrayal related to potentially morally injurious events are rated on a 6 point scale ranging from 1 (strongly agree) to 6 (strongly disagree). Score range is 11-66, with higher scores reflecting greater moral injury.

Measure: Change in score on the Modified Moral Injury Events Scale (Phase I)

Time: Start of Phase I to approximately 2 weeks

Description: 11 item self-report measure that measures moral injury. Statements related to distress or feelings of betrayal related to potentially morally injurious events are rated on a 6 point scale ranging from 1 (strongly agree) to 6 (strongly disagree). Score range is 11-66, with higher scores reflecting greater moral injury.

Measure: Change in score on the Modified Moral Injury Events Scale (Phase II)

Time: Start of Phase II to approximately 5 weeks

Description: The well-validated PCL-5 will assess self-reported PTSD symptom severity. Scores range from 0-80. Higher scores indicate greater symptom severity.

Measure: Change in score on the PTSD Checklist for DSM-5 (PCL-5) (Phase I)

Time: Start of Phase I to approximately 2 weeks

Description: The well-validated PCL-5 will assess self-reported PTSD symptom severity. Scores range from 0-80. Higher scores indicate greater symptom severity.

Measure: Change in score on the PTSD Checklist for DSM-5 (PCL-5) (Phase II)

Time: Start of Phase II to approximately 5 weeks

Description: 10 point visual analog scale to rate the extent to which work/school, social life and home life or family responsibilities are impaired by his or her symptoms. The 3 items can be summed into a single dimensional measure of global functional impairment that ranges from 0 (unimpaired) to 30 (highly impaired).

Measure: Change in score on the Sheehan Disability Scale (SDS) (Phase I)

Time: Start of Phase I to approximately 2 weeks

Description: 10 point visual analog scale to rate the extent to which work/school, social life and home life or family responsibilities are impaired by his or her symptoms. The 3 items can be summed into a single dimensional measure of global functional impairment that ranges from 0 (unimpaired) to 30 (highly impaired).

Measure: Change in score on the Sheehan Disability Scale (SDS) (Phase II)

Time: Start of Phase II to approximately 5 weeks

Description: The minimum score is 0 and the maximum score is 100. High score shows better result.

Measure: Change in score on the World Health Organization Quality of Life Scale - Brief (Phase I)

Time: Start of Phase I to approximately 2 weeks

Description: The minimum score is 0 and the maximum score is 100. High score shows better result.

Measure: Change in score on the World Health Organization Quality of Life Scale - Brief (Phase II)

Time: Start of Phase II to approximately 5 weeks

Description: Subjects rate their own social functioning over times on a 5-point scale on items covering work for pay, housework, extended family, parenting, marital status, social activity and leisure, family unit and student status (sub-scales). Mean values of all the sub-scales are used, with a range from 0-5. Higher score = worse outcome.

Measure: Change in score on the Social Adjustment Scale (SAS) (Phase I)

Time: Start of Phase I to approximately 2 weeks

Description: Subjects rate their own social functioning over times on a 5-point scale on items covering work for pay, housework, extended family, parenting, marital status, social activity and leisure, family unit and student status (sub-scales). Mean values of all the sub-scales are used, with a range from 0-5. Higher score = worse outcome.

Measure: Change in score on the Social Adjustment Scale (SAS) (Phase II)

Time: Start of Phase II to approximately 5 weeks

Description: The scale is comprised of 140 items total. The measure is comprised of 14 different scales and respondents indicate on a 5-point scale the frequency of a stress-related event.

Measure: Change in Score on the Occupational Stress Inventory Revised (OSI-R) (Phase I)

Time: Start of Phase I to approximately 2 weeks

Description: The scale is comprised of 140 items total. The measure is comprised of 14 different scales and respondents indicate on a 5-point scale the frequency of a stress-related event.

Measure: Change in Score on the Occupational Stress Inventory Revised (OSI-R) (Phase II)

Time: Start of Phase II to approximately 5 weeks

Description: 12-item scale with a seven-point scale (from 1=strongly disagree to 7=strongly agree), resulting in a total score in the range of 12-84. Higher scores indicate higher perceived social support by Friends and Family/Significant Others.

Measure: Change in Score on the Multidimensional Scale of Perceived Social Support (MSPSS) (Phase I)

Time: Start of Phase I to approximately 2 weeks

Description: 12-item scale with a seven-point scale (from 1=strongly disagree to 7=strongly agree), resulting in a total score in the range of 12-84. Higher scores indicate higher perceived social support by Friends and Family/Significant Others.

Measure: Change in Score on the Multidimensional Scale of Perceived Social Support (MSPSS) (Phase II)

Time: Start of Phase II to approximately 5 weeks

Description: 33-item self-report measure is designed to assess the degree to which a participant agrees with thoughts and beliefs that have been found to be common for individuals who suffer from PTSD. The measure is rated between 1 (Totally disagree) to 7 (Totally agree). The score range is 33-231. Higher scores indicate greater symptom severity.

Measure: Change in score on the Posttraumatic Cognitions Inventory (Phase I)

Time: Start of Phase I to approximately 2 weeks

Description: 33-item self-report measure is designed to assess the degree to which a participant agrees with thoughts and beliefs that have been found to be common for individuals who suffer from PTSD. The measure is rated between 1 (Totally disagree) to 7 (Totally agree). The score range is 33-231. Higher scores indicate greater symptom severity.

Measure: Change in score on the Posttraumatic Cognitions Inventory (Phase II)

Time: Start of Phase II to approximately 5 weeks

Description: The Difficulties in Emotion Regulation Scale (DERS) is a 36-item self-report measure of six facets of emotion regulation. Items are rated on a scale of 1 ("almost never [0-10%]") to 5 ("almost always [91-100%]"). Higher scores indicate more difficulty in emotion regulation.

Measure: Change in score on the Difficulties in Emotion Regulation Scale (DERS) (Phase I)

Time: Start of Phase I to approximately 2 weeks

Description: The Difficulties in Emotion Regulation Scale (DERS) is a 36-item self-report measure of six facets of emotion regulation. Items are rated on a scale of 1 ("almost never [0-10%]") to 5 ("almost always [91-100%]"). Higher scores indicate more difficulty in emotion regulation.

Measure: Change in score on the Difficulties in Emotion Regulation Scale (Phase II)

Time: Start of Phase II to approximately 5 weeks
29 Hospital Interns Psychological State During the COVID-19 Pandemic

The mental health of the French population in response to covid-19 pandemic is of concern. Health professionals are prone to more mental disorders due to their direct exposure to the pandemic consequences. Indeed, compared to general population, health care workers face enormous in the current health situation, especially those who may be in contact with suspected or confirmed cases (risk of infection, inadequate protection, loss of control, lack of experience in managing the diseases, overwork, stigma, lack of support). Thus, it seems interesting to describe the psychological state of hospital interns during this pandemic.

NCT04669054
Conditions
  1. COVID 19
  2. Depression
  3. Stress Disorders, Post-Traumatic
MeSH:Stress Disorders, Post-Traumatic

Primary Outcomes

Description: evaluation of the participant depressive symptomatology based on the PHQ-9 scale. The PHQ-9 total score ranges from 0 to 27. A score between 0 and 4 indicates absence of depression; a score between 5 and 9 indicates mild depression; a score between 10 and 14 indicates moderate depression; score between 15 and 19 indicates moderately severe depression and score between 20 and 27 indicates sever depression.

Measure: Depressive Symptomatology (PHQ-9)

Time: at 5 months (6 months of internship)

Description: evaluation of the participant depressive symptomatology based on the PHQ-9 scale. The PHQ-9 total score ranges from 0 to 27. A score between 0 and 4 indicates absence of depression; a score between 5 and 9 indicates mild depression; a score between 10 and 14 indicates moderate depression; score between 15 and 19 indicates moderately severe depression and score between 20 and 27 indicates sever depression.

Measure: Depressive Symptomatology (PHQ-9)

Time: at inclusion (1 month of internship)

Description: evaluation of the participant depressive symptomatology based on the PHQ-9 scale. The PHQ-9 total score ranges from 0 to 27. A score between 0 and 4 indicates absence of depression; a score between 5 and 9 indicates mild depression; a score between 10 and 14 indicates moderate depression; score between 15 and 19 indicates moderately severe depression and score between 20 and 27 indicates sever depression.

Measure: Depressive Symptomatology (PHQ-9)

Time: at 2 months (3 months of internship)

Secondary Outcomes

Description: sleep quality evaluation based on the ISI score. The ISI total score ranges from 0 to 28. A score between 0 and 7 indicates an absence of insomnia; a score between 8 and 14 indicates sub-threshold insomnia; a score between 15 and 21 indicates moderate insomnia and a score between 22 and 28 indicates severe insomnia.

Measure: Sleep evaluation with the Insomnia Severity Index (ISI)

Time: at inclusion (1 month of internship)

Description: sleep quality evaluation based on the ISI score. The ISI total score ranges from 0 to 28. A score between 0 and 7 indicates an absence of insomnia; a score between 8 and 14 indicates sub-threshold insomnia; a score between 15 and 21 indicates moderate insomnia and a score between 22 and 28 indicates severe insomnia.

Measure: Sleep evaluation with the Insomnia Severity Index (ISI)

Time: at 2 months (3 months of internship)

Description: sleep quality evaluation based on the ISI score. The ISI total score ranges from 0 to 28. A score between 0 and 7 indicates an absence of insomnia; a score between 8 and 14 indicates sub-threshold insomnia; a score between 15 and 21 indicates moderate insomnia and a score between 22 and 28 indicates severe insomnia.

Measure: Sleep evaluation with the Insomnia Severity Index (ISI)

Time: at 5 months (6 months of internship)

Description: anxiety evaluation based on the GAD-7 score. The GAD-7 total score ranges from 0 to 21. Scores of 5, 10, and 15 represent cut-points for mild, moderate, and severe anxiety, respectively.

Measure: Anxiety with the Generalised Anxiety Disorder Assessment (GAD-7)

Time: at inclusion (1 month of internship)

Description: anxiety evaluation based on the GAD-7 score. The GAD-7 total score ranges from 0 to 21. Scores of 5, 10, and 15 represent cut-points for mild, moderate, and severe anxiety, respectively.

Measure: Anxiety with the Generalised Anxiety Disorder Assessment (GAD-7)

Time: at 2 months (3 months of internship)

Description: anxiety evaluation based on the GAD-7 score. The GAD-7 total score ranges from 0 to 21. Scores of 5, 10, and 15 represent cut-points for mild, moderate, and severe anxiety, respectively.

Measure: Anxiety with the Generalised Anxiety Disorder Assessment (GAD-7)

Time: at 5 months (6 months of internship)

Description: assessment of the psychological pain. The VAS ranges from 0 (none) to 10 (maximum pain).

Measure: Psychological pain assessed with visual analogue scale (VAS)

Time: at inclusion (1 month of internship)

Description: assessment of the psychological pain. The VAS ranges from 0 (none) to 10 (maximum pain).

Measure: Psychological pain assessed with visual analogue scale (VAS)

Time: at 2 months (3 months of internship)

Description: assessment of the psychological pain. The VAS ranges from 0 (none) to 10 (maximum pain).

Measure: Psychological pain assessed with visual analogue scale (VAS)

Time: at 5 months (6 months of internship)

Description: assessment of the physical pain. The VAS ranges from 0 (none) to 10 (maximum pain).

Measure: Physical pain assessed with visual analogue scale (VAS)

Time: at inclusion (1 month of internship)

Description: assessment of the physical pain. The VAS ranges from 0 (none) to 10 (maximum pain).

Measure: Physical pain assessed with visual analogue scale (VAS)

Time: at 2 months (3 months of internship)

Description: assessment of the physical pain. The VAS ranges from 0 (none) to 10 (maximum pain).

Measure: Physical pain assessed with visual analogue scale (VAS)

Time: at 5 months (6 months of internship)

Description: assessment of the suicidal ideation. The VAS ranges from 0 (none) to 10 (maximum ideation).

Measure: Suicidal ideation assessed with visual analogue scale (VAS)

Time: at inclusion (1 month of internship)

Description: assessment of the suicidal ideation. The VAS ranges from 0 (none) to 10 (maximum ideation).

Measure: Suicidal ideation assessed with visual analogue scale (VAS)

Time: at 2 months (3 months of internship)

Description: assessment of the suicidal ideation. The VAS ranges from 0 (none) to 10 (maximum ideation).

Measure: Suicidal ideation assessed with visual analogue scale (VAS)

Time: at 5 months (6 months of internship)

Description: anger assessment with the STAXI state scale. The total score ranges from 0 to 50. The higher the score the higher the anger expression.

Measure: Anger assessed with the State Anger Expression Inventory (STAXI - state)

Time: at 2 months (3 months of internship)

Description: anger assessment with the STAXI state scale. The total score ranges from 0 to 50. The higher the score the higher the anger expression.

Measure: Anger assessed with the State Anger Expression Inventory (STAXI - state)

Time: at 5 months (6 months of internship)

Description: anger assessment with the STAXI state scale. The total score ranges from 0 to 50. The higher the score the higher the anger expression.

Measure: Anger assessed with the State Anger Expression Inventory (STAXI - state)

Time: at inclusion (1 month of internship)

Description: assessement of stressful event impact with the Horowitz scale. The total score ranges from 0 to 45. The higher the score the higher the trauma

Measure: Stressful Event Impact (Horowitz scale)

Time: at inclusion (1 month of internship)

Description: assessement of stressful event impact with the Horowitz scale. The total score ranges from 0 to 45. The higher the score the higher the trauma

Measure: Stressful Event Impact (Horowitz scale)

Time: at 2 months (3 months of internship)

Description: assessement of stressful event impact with the Horowitz scale. The total score ranges from 0 to 45. The higher the score the higher the trauma

Measure: Stressful Event Impact (Horowitz scale)

Time: at 5 months (6 months of internship)

Description: assessement of the psychotropic drugs use increase

Measure: Psychotropic drugs use

Time: at inclusion (1 month of internship)

Description: assessement of the psychotropic drugs use increase

Measure: Psychotropic drugs use

Time: at 5 months (6 months of internship)

Description: assessement of the psychotropic drugs use increase

Measure: Psychotropic drugs use

Time: at 2 months (3 months of internship)

Description: assessement of the tobacco consumption increase

Measure: Tobacco consumption

Time: at 2 months (3 months of internship)

Description: assessement of the tobacco consumption increase

Measure: Tobacco consumption

Time: at inclusion (1 month of internship)

Description: assessement of the tobacco consumption increase

Measure: Tobacco consumption

Time: at 5 months (6 months of internship)

Description: assessement of the alcohol consumption increase

Measure: Alcohol consumption

Time: at 2 months (3 months of internship)

Description: assessement of the alcohol consumption increase

Measure: Alcohol consumption

Time: at inclusion (1 month of internship)

Description: assessement of the alcohol consumption increase

Measure: Alcohol consumption

Time: at 5 months (6 months of internship)

Description: assessement of the illicit substances use increase

Measure: Illicit substances use

Time: at inclusion (1 month of internship)

Description: assessement of the illicit substances use increase

Measure: Illicit substances use

Time: at 2 months (3 months of internship)

Description: assessement of the illicit substances use increase

Measure: Illicit substances use

Time: at 5 months (6 months of internship)

HPO Nodes


HPO

Alphabetical listing of all HPO terms. Navigate: Correlations   Clinical Trials


HPO Nodes


Reports

Data processed on January 01, 2021.

An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.

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Interventions

4,818 reports on interventions/drugs

MeSH

706 reports on MeSH terms

HPO

306 reports on HPO terms

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Alphabetical index of all Terms

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