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D020447: Parasomnias

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 (7)


Name (Synonyms) Correlation
drug2324 Online Intervention Mental Health COVID-19 Wiki 0.41
drug1 "Calm" is a mindfulness meditation mobile app Wiki 0.41
drug713 Calm Meditation App Wiki 0.41
Name (Synonyms) Correlation
drug2860 Remote Cognitive Behavioral Therapy for Insomnia Wiki 0.41
drug4130 survey Wiki 0.17
drug2752 Questionnaires Wiki 0.15
drug2741 Questionnaire Wiki 0.07

Correlated MeSH Terms (4)


Name (Synonyms) Correlation
D020920 Dyssomnias NIH 0.91
D012893 Sleep Wake Disorders NIH 0.24
D003866 Depressive Disorder NIH 0.08
Name (Synonyms) Correlation
D003863 Depression, NIH 0.05

Correlated HPO Terms (1)


Name (Synonyms) Correlation
HP:0000716 Depressivity HPO 0.09

Clinical Trials

Navigate: Correlations   HPO

There are 6 clinical trials


1 Effects of a Mobile Meditation App on Stress During COVID-19 Pandemic in Outpatient Obstetrics and Gynecology Patients; a Randomized Controlled Trial

Due to the COVID-19 global health pandemic, many people are likely experiencing increased stress. Many obstetrics and gynecology patients are additionally experiencing increased stress due to the healthcare changes the COVID-19 pandemic has caused including delayed or canceled elective surgeries, visitor restrictions, and telemedicine visits instead of in person clinic visits. Mindfulness meditation is a self-management strategy that can be utilized by anyone to assist with the management of stress. Mindfulness meditation mobile applications, such as the "Calm" app, can be used to help manage stress, especially during this uncertain time. The investigators propose a prospective randomized controlled trial evaluating perceived stress, anxiety, and sleep disturbance in the investigators outpatient OB/Gyn patients at Banner Women's Institute, with the use of a 30 day trial of the mindfulness meditation app, "Calm." All patients would ultimately receive a 30 day free trial of the mobile meditation app, however the intervention group would receive the 30-day free trial immediately and the control group would receive the 30-day free trial after the study period which is 30 days after enrollment. The investigators additionally want to evaluate the feasibility of using the mobile app, including looking at adherence to use of the app and patient satisfaction with use of the app.

NCT04329533
Conditions
  1. Perceived Stress
  2. Anxiety
  3. Sleep Disturbance
Interventions
  1. Other: "Calm" is a mindfulness meditation mobile app
MeSH:Dyssomnias Parasomnias

Primary Outcomes

Description: Validated perceived stress scale survey, 10 questions in length rated on a 5-point Likert scale ranging from 0 (never) to 4 (very often). Scores are obtained by reversing responses (e.g., 0 = 4, 1 = 3, 2 = 2, 3 = 1 & 4 = 0) to the four positively stated items (items 4, 5, 7, & 8) and then summing across all scale items. Individual scores can range from 0 to 40 with higher scores indicating higher perceived stress.

Measure: Perceived Stress Scale

Time: Completed study Day 0

Description: Validated perceived stress scale survey, 10 questions in length rated on a 5-point Likert scale ranging from 0 (never) to 4 (very often). Scores are obtained by reversing responses (e.g., 0 = 4, 1 = 3, 2 = 2, 3 = 1 & 4 = 0) to the four positively stated items (items 4, 5, 7, & 8) and then summing across all scale items.Individual scores can range from 0 to 40 with higher scores indicating higher perceived stress.

Measure: Perceived Stress Scale

Time: Completed study Day 14

Description: Validated perceived stress scale survey, 10 questions in length rated on a 5-point Likert scale ranging from 0 (never) to 4 (very often). Scores are obtained by reversing responses (e.g., 0 = 4, 1 = 3, 2 = 2, 3 = 1 & 4 = 0) to the four positively stated items (items 4, 5, 7, & 8) and then summing across all scale items.Individual scores can range from 0 to 40 with higher scores indicating higher perceived stress.

Measure: Perceived Stress Scale

Time: Completed study Day 30

Secondary Outcomes

Description: Validated anxiety and depression scale survey, 14 questions in length rated on a 4-point Likert scale. Possible scores range from 0 to 21 for anxiety and 0 to 21 for depression with higher scores indicating probable presence of the mood disorder.

Measure: Hospital Anxiety and Depression Scale

Time: Completed study Day 0, study Day 14, and study Day 30

Description: Patient Reported Outcomes Measurement Information System (PROMIS) is a validated sleep disturbance short form survey, 8 questions in length rated on a 5-point Likert scale ranging from 1 (not at all) to 5 (very much). Possible scores range from 0 to 21 for anxiety and 0 to 21 for depression with higher scores indicating greater severity of sleep disturbance.

Measure: PROMIS Sleep Disturbance Short Form Survey

Time: Completed study Day 0, study Day 14, and study Day 30

Description: Usage data from mobile app, minutes per day used, days per week used

Measure: Adherence

Time: From Day 0 to Day 30

Description: Investigator developed satisfaction questionnaire completed on Day 30, 13 questions in length and measured with 5-point Likert scale.

Measure: Participant Satisfaction

Time: Completed study Day 30

Description: Investigator developed questionnaire about perceptions on coronavirus completed on Day 0 and Day 30, 10 questions in length and measured with 5-point Likert scale.

Measure: Coronavirus Questionnaire

Time: Completed study Day 0 and study Day 30
2 Sleep Quality During COVID-19 Containment in Children 7 to 12 Years Old, Whether or Not Usually Followed in Child Psychiatry

The purpose of this study is to determine whether sleep disturbances in children aged 7 to 12 during COVID-19 containment are more prevalent in children who received routine psychiatric care before containment compared to children who don't have any psychiatric care.

NCT04370210
Conditions
  1. Sleep Disturbance
Interventions
  1. Behavioral: Questionnaires
MeSH:Dyssomnias Parasomnias

Primary Outcomes

Description: Sleep quality is assessed in both groups with the Sleep Disturbance Scale for Children (SDSC scale). A score ≥ 45/125 is considered as pathological.

Measure: Comparison of sleep quality during COVID-19 containment between children usually followed in child psychiatry and children without follow-up

Time: An average of 1 day

Secondary Outcomes

Description: Child depression is measured using Child Depression Inventory Scale (CDI scale). For each item the score is graded by severity from 0 (normal behavior) to 2 (severe).

Measure: Assessment of child depression in both groups

Time: An average of 1 day

Description: Child anxiety is measured using Revised Children's Manifest Anxiety Scale (RCMAS). For each item, child answer by Yes or No. The total score is interpreted using the correspondence tables in function of sex and age

Measure: Assessment of child anxiety in both groups

Time: An average of 1 day

Description: Sleep quality is assessed with the Sleep Disturbance Scale for Children (SDSC scale). The score obtained is interpreted in function of socio-demographic factors (age, sex, lifestyle, couple status, profession and socio-professional category, education)

Measure: Assessment of the influence of socio-demographic factors on sleep in both groups

Time: An average of 1 day

Description: Sleep quality is assessed with the Sleep Disturbance Scale for Children (SDSC scale). For their parents, sleep quality and anxiety level are measured with a numerical scale between 0 and 10. For sleep quality, 0 correspond to a very poor quality and 10 to a very good quality. For anxiety level, 0 correspond to no anxiety and 10 to a severe anxiety. The score obtained for child is interpreted in function of their parents score.

Measure: Measure of the correlation between child sleep quality and parents sleep quality (anxiety level) in both groups

Time: An average of 1 day

Description: Sleep quality is assessed with the Sleep Disturbance Scale for Children (SDSC scale). The score obtained is interpreted in function of child psychiatry diagnoses coded with Diagnostic and Statistical Manual of Mental Disorders (DSM-5)

Measure: Assessment of sleep disturbance based on psychiatry diagnoses in the group of children usually followed in child psychiatry

Time: An average of 1 day

Description: Child anxiety is measured using Revised Children's Manifest Anxiety Scale (RCMAS). For each item, child answer by Yes or No. The score obtained is interpreted in function of child psychiatry diagnoses coded with Diagnostic and Statistical Manual of Mental Disorders (DSM-5)

Measure: Assessment of child anxiety based on psychiatry diagnoses in the group of children usually followed in child psychiatry

Time: An average of 1 day

Description: Child depression is measured using Child Depression Inventory Scale (CDI scale). For each item the score is graded by severity from 0 (normal behavior) to 2 (severe). The score obtained is interpreted in function of child psychiatry diagnoses coded with Diagnostic and Statistical Manual of Mental Disorders (DSM-5)

Measure: Assessment of child depression based on psychiatry diagnoses in the group of children usually followed in child psychiatry

Time: An average of 1 day
3 Effects of a Mobile App on Health and Well-being During COVID-19 Pandemic in House Staff at Banner University Medical Center Phoenix

Due to the COVID-19 global health pandemic, many people are likely experiencing increased stress. The well-being of physicians in training may be significantly impacted by this pandemic. Meditation is a self-management strategy that can be utilized by anyone to assist with the management of stress. Meditation mobile applications, such as the "Calm" app, can be used to help manage stress, especially during this uncertain time. The investigators propose a prospective evaluation of perceived stress, anxiety, burnout and sleep disturbance in the house staff at Banner University Medical Center Phoenix, with the use of the mobile meditation app, "Calm." The investigatros additionally want to evaluate the feasibility of using the mobile app, including looking at adherence to use of the app and physician satisfaction with use of the app.

NCT04374786
Conditions
  1. Perceived Stress
  2. Anxiety
  3. Sleep Disturbance
  4. Burnout
  5. PTSD
Interventions
  1. Device: Calm Meditation App
MeSH:Dyssomnias Parasomnias

Primary Outcomes

Description: Validated perceived stress scale survey, 10 questions in length rated on a 5-point Likert scale ranging from 0 (never) to 4 (very often). Scores are obtained by reversing responses (e.g., 0 = 4, 1 = 3, 2 = 2, 3 = 1 & 4 = 0) to the four positively stated items (items 4, 5, 7, & 8) and then summing across all scale items. Individual scores can range from 0 to 40 with higher scores indicating higher perceived stress.

Measure: Perceived Stress Scale

Time: Completed study Day 0

Description: Validated perceived stress scale survey, 10 questions in length rated on a 5-point Likert scale ranging from 0 (never) to 4 (very often). Scores are obtained by reversing responses (e.g., 0 = 4, 1 = 3, 2 = 2, 3 = 1 & 4 = 0) to the four positively stated items (items 4, 5, 7, & 8) and then summing across all scale items. Individual scores can range from 0 to 40 with higher scores indicating higher perceived stress.

Measure: Perceived Stress Scale

Time: Completed study Day 14

Description: Validated perceived stress scale survey, 10 questions in length rated on a 5-point Likert scale ranging from 0 (never) to 4 (very often). Scores are obtained by reversing responses (e.g., 0 = 4, 1 = 3, 2 = 2, 3 = 1 & 4 = 0) to the four positively stated items (items 4, 5, 7, & 8) and then summing across all scale items. Individual scores can range from 0 to 40 with higher scores indicating higher perceived stress.

Measure: Perceived Stress Scale

Time: Completed study Day 30

Secondary Outcomes

Description: Validated anxiety and depression scale survey, 14 questions in length rated on a 4-point Likert scale. Possible scores range from 0 to 21 for anxiety and 0 to 21 for depression with higher scores indicating probable presence of the mood disorder.

Measure: Hospital Anxiety and Depression Scale

Time: Completed study Day 0, 14, and study Day 30

Description: Patient Reported Outcomes Measurement Information System (PROMIS) is a validated sleep disturbance short form survey, 8 questions in length rated on a 5-point Likert scale ranging from 1 (not at all) to 5 (very much). Possible scores range from 0 to 21 for anxiety and 0 to 21 for depression with higher scores indicating greater severity of sleep disturbance.

Measure: PROMIS Sleep Disturbance Short Form Survey

Time: Completed study Day 0, 14, and study Day 30

Description: The Impact of Event Scale-6 is a validated post traumatic event survey, 6 questions in length rated on a 5-point Likert scale ranging from 1 (not at all) to 5 (extremely). The score ranges from a minimum of 6 to a maximum of 30 with higher scores indicating higher traumatic stress.

Measure: Impact of Event Scale-6

Time: Completed study Day 0, 14, and study Day 30

Description: The Maslach Burnout Inventory is a validated burnout survey, 22 questions in length with 3 sub scales including emotional exhaustion, depersonalization, and personal accomplishment. Each question is rated on a 7 point Likert scale ranging from 0 (never) to 6 (every day). The score for each sub scales range from minimum 0 to maximum 18. High scores of emotional exhaustion and depersonalization sub scales and a lower score of personal accomplishment indicates a higher level of burnout.

Measure: Maslach Burnout Inventory

Time: Completed study Day 0, 14, and study Day 30

Description: Usage data from mobile app, minutes per day used

Measure: Adherence

Time: From Day 0 to Day 30

Description: Investigator developed questionnaire about perceptions on coronavirus completed on Day 0 and Day 30, 10 questions in length and measured with 5-point Likert scale. 1= very low, 2=low, 3=moderate, 4=high, 5= very high.

Measure: Coronavirus Questionnaire

Time: Completed study Day 0 and study Day 30

Description: Investigator developed satisfaction questionnaire completed on Day 30, 13 questions in length.

Measure: Participant Satisfaction

Time: Completed study Day 30
4 Harnessing Telehealth to Mitigate the Impact of the COVID-19 Pandemic on Sleep, Suicidality, and Neuropsychiatric Symptoms

The purpose of this study is to investigate whether an empirically validated treatment for insomnia (CBT-I) administered early in the course of sleep disturbance can prevent insomnia disorder or lessen negative mental health outcomes in the wake of the COVID-19 crisis in adults.

NCT04409743
Conditions
  1. Sleep Disturbance
  2. Insomnia
Interventions
  1. Behavioral: Remote Cognitive Behavioral Therapy for Insomnia
MeSH:Dyssomnias Parasomnias

Primary Outcomes

Description: Whether the participant has an insomnia clinical diagnosis will be measured by the DUKE. The DUKE is a structured interview which screens for sleep disorders in accordance with criteria of both the DSM-IV and the international classification of sleep disorders (ICSD-2). The DUKE is composed of 4 modules that assess sleep disorder symptoms associated with complaints of insomnia, sleep disorders associated with complaints of hypersomnia, circadian rhythm sleep disorders, and sleep disorders associated with parasomnias.

Measure: Change in Insomnia Clinical Diagnosis

Time: Assessed at week 0 and week 15

Description: This measure is of the Beck Depression Inventory-II total score after excluding one sleep item. The average item score for the remaining 20 items will be multiplied by 21 (the original number of items), to create a modified depression scale that maintains the original range (ranges: 0-13 minimal, 14-19 mild, 20-28 moderate, and 29-63 severe). The BDI-II is a 21-item self-report scale with high validity and reliability that assesses the severity of depression symptoms. The depression items consist of: sadness, pessimism, past failure, loss of pleasure, guilty feelings, punishment feelings, self-dislike, self-criticalness, suicidal thoughts or wishes, crying, agitation, loss of interest, indecisiveness, worthlessness, loss of energy, changes in sleeping pattern, irritability, changes in appetite, concentration difficulty, tiredness or fatigue, and loss of interest in sex. Items are scored from 0 to 3, and higher scores indicate greater levels of severity.

Measure: Change in Beck Depression Inventory-II (BDI) Scale Score

Time: Assessed at week 0 and week 15

Description: Clinical anxiety symptoms will be measured by the BAI. The BAI is a 21-item self-report scale that assesses the severity of anxiety symptoms. Items are scored from 0 to 3 (0 = not at all, 3 = severe). Higher scores indicate greater levels of severity, and the ranges for anxiety levels are: 0-9 normal to minimal, 10-18 mild to moderate, 19-29 moderate to severe, and 30-63 severe. The BAI consists of two factors: somatic and cognitive.

Measure: Change in Beck Anxiety Inventory (BAI) Scale Score

Time: Assessed at week 0 and week 15

Description: The SF-36 is a 36-item self-administered survey to assess comprehensive quality-of-life measures. It consists of eight sections: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, and mental health. This survey is widely used and has been proven to be a reliable indicator of quality-of-life measures. The global score range is 0-100, with higher scores indicating better health conditions.

Measure: Change in Quality of Life (SF-36) Scale Score

Time: Assessed at week 0 and week 15

Description: Suicidality ideation and behaviors will be measured by the S-STS. The S-STS is a 16-item 0 to 4 scale (0 = no problem, 4 = very severe problem) that assesses the risk of suicidality. For this outcome measure, 15 items (excluding #13) are summed for an overall score range of 0 to 45 (higher scores indicate more severe problems).

Measure: Change in Sheehan Suicidality Tracking Scale (S-STS) Score

Time: Assessed at week 0 and week 15

Description: The FIRST is 9 item self-report that assess sleep reactivity with individual items scored on a 1 - 4 scale (1 = Not Likely, 4 = Very Likely). This self-report tools measures the risk of participants experiencing situational insomnia due to common stressful conditions. The FIRST has good reliability and validity and has demonstrated high internal consistency across multiple demographics in both males and females, in young and middle-aged adults, and in clinical and population-based samples. Individual items are summed for a total score range of 9 to 36, with higher scores corresponding to more difficulty sleeping

Measure: Change in Ford Insomnia Response to Stress Test (FIRST) Scale Score

Time: Assessed at week 0 and week 15

Description: Loneliness risk factors will be assessed with the UCLA Loneliness Scale that measures a participant's subjective feelings of loneliness and social isolation. The UCLA Loneliness Scale has 20 items, each on a 1 to 4 scale (1 = Never, 4 = Often), summed for an overall range of 20 to 80 with higher scores indicating greater degrees of loneliness.

Measure: Change in UCLA Loneliness Scale Score

Time: Assessed at week 0 and week 15

Description: The Social Network Index is a 12-item questionnaire that assess participation in different types of social relationships. The 12 types of relationships (e.g. friend, children, spouse, religious group member) are scored by the number network members they communicate with at least every 2 weeks.

Measure: Change in Social Network Index (SNI) Scale Score

Time: Assessed at week 0 and week 15

Description: The Perceived Stress Scale is a widely used self-reported questionnaire that assesses how stressful participants believe their live is. Items are generalized and measure the degree participants judge their lives to be uncontrollable and unpredictable over the course of the previous month.

Measure: Change in Perceived Stress Scale Score

Time: Assessed at week 0 and week 15

Description: Self-report questions regarding screen time will be included in the Coronavirus Health Impact Survey. Questions measure the amount of time spent per day, over the course of the two most recent weeks, using an electronic device.

Measure: Change in Screen Time- Self Report

Time: Assessed at week 0 and week 15

Description: The International Physical Activity Questionnaire assess an individual's physical activity across 5 life domains over the last 7 days. The activity domains consist of physical activity related to work, transportation, housework and caring for family, and recreation and sports as well as the amount of time spent sitting. The IPAQ has high reliability and validity and has been widely used to measure comparable estimates of physical activity in large populations.

Measure: Change in International Physical Activity Questionnaire (IPAQ) Scale Score

Time: Assessed at week 0 and week 15

Secondary Outcomes

Description: Sleep Onset Latency (SOL) is the time (minutes) from "lights out" to actually falling asleep (sleep onset) based on sleep logs.

Measure: Change in Sleep Onset Latency (SOL) as a Measure of Sleep Continuity

Time: Assessed at week 0 and week 15

Description: Number of Arousals is determined by number of times of awakening as seen on the actigraph data.

Measure: Change in Number of Arousals as a Measure of Sleep Continuity

Time: Assessed at week 0 and week 15

Description: Wake After Sleep Onset (WASO) are periods of wakefulness occurring after sleep onset, before final awakening (sleep offset).

Measure: Change in Wake After Sleep Onset (WASO) as a Measure of Sleep Continuity

Time: Assessed at week 0 and week 15

Description: Total Sleep Time (TST) is the total time spent asleep, from the start of sleep onset to sleep offset subtracting any periods of wakefulness.

Measure: Change in Total Sleep Time (TST) as a Measure of Sleep Continuity

Time: Assessed at week 0 and week 15

Description: Sleep Efficiency (SE) is calculated as TST divided by total time spent in bed, multiplied by 100.

Measure: Change in Sleep Efficiency (SE) as a Measure of Sleep Continuity

Time: Assessed at week 0 and week 15

Description: Subjective ratings of sleep disturbance and insomnia severity will be assessed with the Insomnia Severity Index. The Insomnia Severity Index (ISI) is a 7-item self-report measure of insomnia type, severity, and impact on functioning. The items consist of severity of sleep onset, sleep maintenance, early morning awakenings, sleep dissatisfaction, interference with daytime functioning, noticeability of sleep problems by others, and distress caused by sleep difficulties. Items are scored from 0 to 4 (0 = no problem, 4 = very severe problem). Score ranges of insomnia are: 0-7 absent, 8-14 sub-threshold, 15-21 moderate, and 22-28 severe. The ISI has good validity and reliability.

Measure: Change in Insomnia Severity Index (ISI) Scale Score

Time: Assessed at week 0 and week 15

Description: The PHQ-9 is a self-administered 9-item 0 to 3 scale (0 = not at all, 3 = nearly every day) questionnaire that assess each of the 9 DSM-IV depression criteria. The total score ranges from 1 - 27 which measures the severity of the reported depression with consideration for both Major Depressive Disorder and other depressive disorders based on the number of items that were rated a 2 to 3.

Measure: Change in Patient Health Questionnaire-9 (PHQ-9) Scale Score as a Measure of Depression Symptoms

Time: Assessed at week 0 and week 15

Description: The GAD-7 is a widely used diagnostic self- report scale that screens, diagnoses, and assess severity of anxiety disorder. The GAD-7 is a 7-item 0 to 3 (0 = Not at all, 3 = Nearly every day) scale that measures the degree of severity of anxiety over the last 2 weeks with a total score ranging from 0 to 21, with a higher score indicating a more severe anxiety.

Measure: Change in Generalized Anxiety Disorder-7 (GAD-7) Scale Score

Time: Assessed at week 0 and week 15
5 Effectiveness of a Self-applied Positive Psychology Online Intervention Program "Mental Health COVID-19" in Mexican Population: A Randomized Controlled Trial.

This study evaluates the effectiveness of a Positive Psychology intervention, that is focused on increasing the positive emotions and strengths of human beings. It is compared to the effectiveness of an online treatment with the change of the same participants before and after receiving the treatment accompanied by a chat support service vs. the treatment solely. The changes are being assessed through worldwide validated measures such as psychometrics.

NCT04468893
Conditions
  1. Anxiety
  2. Depression
  3. Sleep Disturbance
Interventions
  1. Behavioral: Online Intervention Mental Health COVID-19
MeSH:Dyssomnias Parasomnias Depression Depressive Disorder
HPO:Depressivity

Primary Outcomes

Description: The State/Trait Anxiety Inventory consists of two subscales of 20 items each that measure anxiety as a transient state of tension (Scale A-State), and as a characteristic of the personality relatively stable over time (Scale B -trait). The items are composed by an assertion to which the subject responds indicating their degree of identification. In the case of state anxiety, the scale goes from 1 (not at all), 2 (somewhat), 3 (moderately), 4 (very much), while in the trait anxiety it ranges from 1 (almost never), 2 (sometimes), 3 (often), 4 (almost always). In both, a percentage of the items evaluate well-being or absence of anxiety, while the rest of the items to the presence of anxiety. Scores range from 20 to 80, in each subscale, with higher scores correlating with greater anxiety. It is expected a statistically significant decrease (P < 0.05) in the anxiety symptoms.

Measure: Decrease in the score of Anxiety symptoms

Time: [Time Frame: 2 weeks to one month, depending on the development of the patient and the completion of the 15 modules.]

Description: The Beck Depression Inventory is a self-report that provides a measure of the presence and severity of depression. Contains 21 items indicative of symptoms such as sadness, crying, loss of pleasure, feelings of failure and guilt, suicidal thoughts or desires, pessimism, etc. Each item is answered on a 4-point scale, from 0 to 3, where each number is identified differently for each item, in all of them 0 means absence and 3 full presence (e.g. sadness), except for items 16 (changes in the sleep pattern) and 18 (changes in appetite) that contain 7 categories. The minimum and maximum scores in the test are 0 and 63. Cut-off points ha that allow classifying those evaluated in one of the following four groups: 0-13, minimum depression; 14-19, mild depression; 20-28, moderate depression; and 29-63, severe depression. It is expected a statistically significant decrease (P < 0.05) in the depression symptoms.

Measure: Change in the symptoms of depression

Time: [Time Frame: 2 weeks to one month, depending on the development of the patient and the completion of the 15 modules.]

Description: On the Generalized Anxiety Disorder 7-item (GAD-7) scale subjects are asked how often, during the last 2 weeks, they have been bothered by each of the 7 core symptoms of generalized anxiety disorder. Response options are "not at all," "several days," "more than half the days," and "nearly every day," scored as 0, 1, 2, and 3, respectively. Therefore, GAD-7 scores range from 0 to 21, with scores of ≥5, ≥10, and ≥15 represent mild, moderate, and severe anxiety symptom levels, respectively. It is expected a statistically significant decrease (P < 0.05) in the General Anxiety symptoms.

Measure: Change in the symptoms of General Anxiety Disorder

Time: [Time Frame: 2 weeks to one month, depending on the development of the patient and the completion of the 15 modules.]

Description: The Scale of Post-traumatic Stress Traits in the Mexican Youth Exposed to Social Violence It is a brief scale with 24 symptoms corresponding to the diagnosis of PTSD, to respond by self-report, and a scale was used discretely from 1 (strongly disagree) to 4 (strongly agree). The total score was obtained by arithmetic sum. The minimum possible is 24 and the maximum 96. It is expected a statistically significant decrease (P < 0.05) in the posttraumatic stress symptoms.

Measure: Change in the score of Posttraumatic stress symptoms

Time: [Time Frame: 2 weeks to one month, depending on the development of the patient and the completion of the 15 modules.]

Description: It is composed of seven items with options of 0 = nothing, 3 = a lot, and measures the fear in its emotional component, that is, the fear to adversities in the context and the feelings it disseminates, as well as others economic and social fears, in this case, adapted for the Sars-Cov2 pandemic. In previous studies, an acceptable internal consistency of .95 was reached. It consists of several items about the fear of being a SARS Cov2 victim in diverse contexts. In the present study, a Cronbach alpha coefficient of 0.96 was obtained. It is expected a statistically significant decrease (P < 0.05) in the widespread fear symptoms.

Measure: Changes in the Widespread fear Scale

Time: [Time Frame: 2 weeks to one month, depending on the development of the patient and the completion of the 15 modules.]

Description: This instrument assesses the quality patterns of sleep. It differentiates the "poor" and "good" sleep by measuring seven areas, where the range score of answers are from 0 to 3, the global sum of this scale can be a value between 0 to 60, and the cutoff point is "5" that indicates a "poor" sleep quality. It is expected a statistically significant increase (P < 0.05) in the Sleep Quality Index.

Measure: Change in the score of The Pittsburgh Sleep Quality Index.

Time: [Time Frame: 2 weeks to one month, depending on the development of the patient and the completion of the 15 modules.]

Secondary Outcomes

Description: This scale aims to assess the frequency of attitudes, behaviors and plans to commit suicide. It is divided into 19 items with a response option of 0 to 2, giving a total of 0 to 38 where a score equal to or greater than 10 indicates an existing risk of suicide. This scale has been validated in the Mexican population (González-Macip & Díaz-Martínez, 2000).

Measure: Change on the Suicidal Thoughts Scale

Time: [Time Frame: 2 weeks to one month, depending on the development of the patient and the completion of the 15 modules.]
6 Psychological Impact, Mental Health and Sleep Disorder Among Patients Hospitalized and Health Care Workers During the 2019 Coronavirus Outbreak (COVID-19)

COVID-19 is an infectious disease caused by the last coronavirus discovered, called SARS-CoV-2. Symptoms encountered in COVID-19 are: cough, breathing difficulties (dyspnea, chest pain, etc.), pyrexia, anosmia (loss of smell) and/or dysgeusia (loss of taste), but also ENT symptoms (rhinitis type, odynophagia), headaches, asthenia, muscle pain, confusion and diarrhea. Infection with SARS-CoV-2 can also be asymptomatic. COVID-19 can be passed from person to person by respiratory droplets expelled when a person speaks, coughs or sneezes. The currently estimated incubation period ranges from 1 to 14 days, and most often this is around 5 days. According to a literature review, there is strong evidence that COVID-19 has an impact on mental health (anxiety being the most common symptom) whether in the general population, healthcare workers or vulnerable populations. The objective of this project is to assess mental health and sleep disorders within two populations: elderly patients and nursing staff.

NCT04497246
Conditions
  1. Covid19
Interventions
  1. Other: Questionnaire
MeSH:Sleep Wake Disorders Parasomnias

Primary Outcomes

Description: The IES-R is a 22-item self-report measure that assesses subjective distress caused by traumatic events.Items are rated on a 5-point scale ranging from 0 ("not at all") to 4 ("extremely"). 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: Impact Event Scale-Revised (IES-R)

Time: 15 minutes

Description: Self-administered patient questionnaire used as a screening tool and severity measure for generalised anxiety disorder (GAD).The GAD-7 score is calculated by assigning scores of 0, 1, 2, and 3, to the response categories of 'not at all', 'several days', 'more than half the days', and 'nearly every day', respectively, and adding together the scores for the seven questions. Scores of 5, 10, and 15 are taken as the cut-off points for mild, moderate and severe anxiety, respectively. When used as a screening tool, further evaluation is recommended when the score is 10 or greater.

Measure: Generalised Anxiety Disorder-7 (GAD-7)

Time: 15 minutes

Description: The PHQ-9 is the depression module, which scores each of the nine DSM-IV criteria as "0" (not at all) to "3" (nearly every day). It has been validated for use in primary care. It is not a screening tool for depression but it is used to monitor the severity of depression and response to treatment.

Measure: Patient Health Questionnaire-9 (PHQ-9)

Time: 15 minutes

Description: The ISI is a 7-item self-report questionnaire assessing the nature, severity, and impact of insomnia.The dimensions evaluated are: severity of sleep onset, sleep maintenance, and early morning awakening problems, sleep dissatisfaction, interference of sleep difficulties with daytime functioning, noticeability of sleep problems by others, and distress caused by the sleep difficulties. A 5-point Likert scale is used to rate each item (e.g., 0 = no problem; 4 = very severe problem), yielding a total score ranging from 0 to 28. The total score is interpreted as follows: absence of insomnia (0-7); sub-threshold insomnia (8-14); moderate insomnia (15-21); and severe insomnia (22-28).

Measure: Insomnia severity index (ISI)

Time: 15 minutes

Secondary Outcomes

Description: Age, gender, familial status, home status (living alone/family support/healthcare support/ retirement home).

Measure: Demographic data

Time: 1 year

Description: Hospitalization duration

Measure: Hospitalization duration

Time: 1 year

Description: Hospitalization within the intensive care unit (yes/no) with or without intubation

Measure: ICU stay

Time: 1 year

Description: History of chronic diseases

Measure: Medical history

Time: 1 year

Description: Alcohol consumption : none - stable - increased - diminished

Measure: Alcohol consumption

Time: 1 year

Description: Tobacco consumption : none - stable - increased - diminished

Measure: Tobacco consumption

Time: 1 year

HPO Nodes


HPO

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


HPO Nodes


Reports

Data processed on September 26, 2020.

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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