Covid 19 Research using Clinical Trials (Home Page)
Report for D001008: Anxiety Disorders NIH
(Synonyms: Anxiety D, Anxiety Di, Anxiety Dis, Anxiety Diso, Anxiety Disor, Anxiety Disord, Anxiety Disorder, Anxiety Disorders)
Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation
Correlated Drug Terms (21)
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug387 | Crisis intervention therapy Wiki | 0.32 |
| drug429 | Digital intervention Wiki | 0.32 |
| drug247 | COVID-19 Convalescent Plasma Wiki | 0.32 |
| drug236 | CLIA of IgG and IgM against SARS-Cov-2 Wiki | 0.32 |
| drug243 | COVID 19 diagnostic test by PCR Wiki | 0.32 |
| drug1669 | survey work Wiki | 0.32 |
| drug228 | CAP-1002 Allogeneic Cardiosphere-Derived Cells Wiki | 0.32 |
| drug937 | Online Questionnaire Wiki | 0.32 |
| drug832 | MinnRAP Peer Support Program Wiki | 0.32 |
| drug1548 | covid-19 positive pregnant women Wiki | 0.32 |
| drug114 | Attention Bias Modification (ABM) Wiki | 0.32 |
| drug674 | Information-only intervention Wiki | 0.32 |
| drug244 | COVID Convalescent Plasma Wiki | 0.32 |
| drug242 | COVID 19 Diagnostic Test Wiki | 0.32 |
| drug239 | CONVALESCENT PLASMA Wiki | 0.32 |
| drug217 | Brief cognitive behavioural therapy Wiki | 0.32 |
| drug238 | COM-COVID anonimous survey Wiki | 0.32 |
| drug1473 | Virtual-Care Cognitive Behavioural Therapy Wiki | 0.32 |
| drug235 | CHLORPROMAZINE (CPZ) Wiki | 0.32 |
| drug981 | Pandemic control measures Wiki | 0.32 |
| drug1282 | Standard of Care (SOC) Wiki | 0.22 |
Correlated MeSH Terms (13)
| Name (Synonyms) | Correlation | |
|---|---|---|
| D015775 | Fractures, Stress NIH | 0.32 |
| D013180 | Sprains and Strains NIH | 0.32 |
| D000068376 | Compassion Fatigue NIH | 0.32 |
| D000067073 | Psychological Trauma NIH | 0.32 |
| D001248 | Asthenopia NIH | 0.32 |
| D003863 | Depression, NIH | 0.25 |
| D019052 | Depression, Postpartum NIH | 0.22 |
| D040921 | Stress Disorders, Traumatic NIH | 0.16 |
| D003866 | Depressive Disorder NIH | 0.14 |
| D013313 | Stress Disorders, Post-Traumatic NIH | 0.14 |
| D004194 | Disease NIH | 0.12 |
| D013315 | Stress, Psychological NIH | 0.12 |
| D018352 | Coronavirus Infections NIH | 0.01 |
There are 10 clinical trials
Clinical Trials
1 Reducing Eye Strain and Anxiety Using a Digital Intervention During Online Learning Class Recess Among Children at Home: A Randomized Controlled Trial
The primary aim of the current study is to conduct a cluster-randomized control trial to evaluate the effectiveness of a novel digital intervention in reducing anxiety and digital eye strain compared to usual care among Chinese children during the period of home confinement.
NCT04309097 Anxiety Digital Eye Strain Behavioral: Digital intervention Behavioral: Information-only intervention MeSH:Asthenopia Sprains and Strains Anxiety Disorders
Primary Outcomes
Description: Change in anxiety will be measured by the Spence Children's Anxiety Scale (SCAS) designed by Spence (1998). The SCAS (45-item) is self-report scale with a 4-point Likert type, consisting of 44 items and one open-ended question. Overall assessment is done by total score.
Measure: Change in anxiety Time: Baseline & at 2 weeksSecondary Outcomes
Description: Syndromes of digital eye strain will be measured with the Computer Vision Syndrome Questionnaire (CVS‐Q) designed by Seguí et al (2015). The self-reported CVS-Q questionnaire (16-item) evaluates the frequency (never, occasionally or often/always) and the intensity (moderate or intense) of 16 symptoms: burning, itching, feeling of a foreign body, tearing, excessive blinking, eye redness, eye pain, heavy eyelids, dryness, blurred vision, double vision, difficulty focusing for near vision, increased sensitivity to light, colored halos around objects, feeling that sight is worsening, and headache. Overall assessment is done by total score.
Measure: Change in syndromes of digital eye strain Time: Baseline & at 2 weeksDescription: The PROMIS pediatric sleep disturbance questionnaire (4-item), designed by Forrest et al (2018), assesses self-reported experiences of sleep disturbance over the past 7 days. Raw score will be converted to T-Score.
Measure: Change in sleeping quality Time: Baseline & at 2 weeksDescription: Participants will be asked to indicate the average time in hours per day spent on each the following activities: reading, writing, computer/PAD use, smart phone, watching TV, and playing video games.
Measure: Changes in time (hour) spent on different near work activities Time: Baseline & at 2 weeks2 Online-based Survey of the Anxiety Associated With the COVID-19 Pandemic in the General Population in Germany
The study aims to systematically examine various aspects of the anxiety associated with the COVID-19 pandemic in Germany. The data collection is carried out online with longitudinal repeated measurements.
NCT04331106 Anxiety Related to the COVID-19 Pandemic Diagnostic Test: Online Questionnaire MeSH:Anxiety Disorders
Primary Outcomes
Description: To investigate specific fears regarding the COVID-19 pandemic 9 self created items are used. Values ranging from 1 to 6, higher scores indicate a worse outcome.
Measure: Characteristics of COVID-19-related anxiety Time: 1 dayDescription: Modified German version of the DSM-5 Severity-Measure-For-Specific-Phobia-Adult-Scale by Beesdo-Baum et al. (2014). 10 items, values ranging from 1 to 5, higher scores indicate a worse outcome. The Scale was adapted to anxiety symptoms related to COVID-19.
Measure: COVID-19-related anxiety symptoms Time: 1 daySecondary Outcomes
Description: Self-efficacy and coping with the COVID-19 pandemic are measured with 13 self created items. Values ranging from 1 to 6; higher scores indicate a better outcome (except inverted items).
Measure: Self-efficacy and coping with COVID-19 Time: 1 day + every 3 weeks as long as the COVID-19 pandemic lasts (maximum: 30 weeks from baseline on) and one year later (Follow-Up)Description: Personal consequences of the COVID-19 pandemic in the last three weeks are collected with five self-created items.
Measure: Consequences of COVID-19 in the last three weeks. Time: 1 day + every 3 weeks as long as the COVID-19 pandemic lasts (maximum: 30 weeks from baseline on) and one year later (Follow-Up)Description: General illness attitudes are measured with 3 subscales (Worry about illness; Thanatophobia; Bodily preoccupations) of the German version of the Illness Attitude Scales (IAS) by Hiller & Rief (2004). 9 Items; values ranging from 1 to 5, higher scores indicate a worse outcome.
Measure: General Illness Attitude Time: 1 day + every 3 weeks as long as the COVID-19 pandemic lasts (maximum: 30 weeks from baseline on) and one year later (Follow-Up)Description: Frequency, effects and formats of consumed media related to COVID-19 are measured with 5 self created items.
Measure: Media reporting Time: 1 day + every 3 weeks as long as the COVID-19 pandemic lasts (maximum: 30 weeks from baseline on) and one year later (Follow-Up)Description: To screen for general anxiety and depressive symptoms the German version of the Patient Health Questionnaire-4 (PHQ-4) by Löwe (2015) is used. 4 items; values ranging from 0 to 3, higher scores indicate a worse outcome.
Measure: Ultra-brief screening scale for anxiety and depression Time: 1 day + every 3 weeks as long as the COVID-19 pandemic lasts (maximum: 30 weeks from baseline on) and one year later (Follow-Up)Description: To investigate specific fears regarding the COVID-19 pandemic 9 self created items are used. Values ranging from 1 to 6, higher scores indicate a worse outcome.
Measure: Change in characteristics of COVID-19-related anxiety Time: Every 3 weeks as long as the COVID-19 pandemic lasts (maximum: 30 weeks from baseline on) and one year later (Follow-Up)Description: Modified German version of the DSM-5 Severity-Measure-For-Specific-Phobia-Adult-Scale by Beesdo-Baum et al. (2014). 10 items, values ranging from 1 to 5, higher scores indicate a worse outcome. The Scale was adapted to anxiety symptoms related to COVID-19.
Measure: Change in COVID-19-related anxiety symptoms Time: Every 3 weeks as long as the COVID-19 pandemic lasts (maximum: 30 weeks from baseline on) and one year later (Follow-Up)3 The Ariel University Survey on Dietary Changes and Anxiety During the Coronavirus Pandemic: TARUS
Background/Objectives: Psychological anxiety has been associated with alterations in eating patterns. The 2020 global coronavirus pandemic has created a situation characterized by increased anxiety. The present international survey was designed to examine associations between exposure to quarantine/isolation measures, anxiety levels and changes in dietary patterns. Methods: The present study utilizes a Google Survey platform to conduct an international survey querrying dietary patterns before vs. after the coronavirus pandemic; anxiety during the pandemic; and demographic characteristics. The nutrition portion of the survey is based on the Mediterranean Diet Score while the anxiety estimate is based on the GAD-7. The survey is available in English, Hebrew, Spanish, Italian, French, Arabic and Russian. It has been distributed via social media. Anticipated Results: We believe that changes in dietary habits will be identified and that these will be associated with anxiety levels. Additionally, we believe that by-country differences will be identified. Discussion: The Google Survey format distributed by social media provides an almost immediate means of distributing the survey globally. The survey can only be completed if the respondent first indicates his/her informed consent. The convenience sample limits generalizability to individuals who volunteer to complete online surveys; however, we anticipate a large response which may mitigate this limitation.
NCT04353934 Dietary Habits Anxiety MeSH:Coronavirus Infections Anxiety Disorders
Primary Outcomes
Description: The Mediterranean Diet Score (MedDiet Score) will be calculated and correlated to the Anxiety Score (GAD-7)
Measure: The association between Mediterranean Diet Score and Anxiety Score Time: through study completion, average six monthsDescription: Mediterranean Diet Score (MedDiet) will be calculated
Measure: The degree to which current dietary intake is consisten with the Mediterranean Diet Time: through study completion, average six monthsSecondary Outcomes
Description: By-country comparisons of the association between Mediterranean Diet (MedDiet) score and Anxiety (GAD-7)
Measure: By-country comparisons of the association between Mediterranean Diet (MedDiet) score and Anxiety Time: through study completion, average six months4 Attention Bias Modification for Reducing Health Anxiety During the Coronavirus Pandemic: An Open Pilot Trial
The outbreak of the 2019 Coronavirus (COVID-19) pandemic is a major stressor leading to increased levels of anxiety, and specifically, an excessive fear of being infected and affected by the disease among major parts of the population. At the same time, the access to mental health services is limited due to the lockdown policy applied in many countries worldwide, warranting the development of home-delivered interventions aimed at reducing stress and anxiety symptoms. Attention Bias modification (ABM) has been found to be an efficacious computerized intervention to reduce anxiety symptoms. In this open pilot trial, participants reporting on elevated levels of health anxiety concerning the COVID-19 epidemic will receive one session of ABM over 5 consecutive days (5 sessions total). Symptoms of health anxiety, state anxiety, generalized anxiety, and depression will be measured at baseline and post-treatment.
NCT04365972 Anxiety Behavioral: Attention Bias Modification (ABM) MeSH:Anxiety Disorders
Primary Outcomes
Description: The COVID-19 anxiety inventory is a self-report questionnaire screening for concerns and fears regarding COVID-19 contagion. The Inventory consists of 6 items. Scores can range from 6 to 30, with higher scores denoting higher symptom severity.
Measure: Change from baseline of the total score of a novel COVID-19 anxiety inventory Time: up to 2 days pre-treatment and 1-2 days post-treatmentSecondary Outcomes
Description: The Health Anxiety Inventory (HAI) is a validated self-report measure assessing health anxiety. Total score can range from 0 to 42, with higher scores denoting higher symptom severity
Measure: Change from baseline of the total score of the Health Anxiety Inventory Time: up to 2 days pre-treatment and 1-2 days post-treatmentDescription: The State Anxiety Inventory is a validated self-report measure for state anxiety. Total score can range from 20 to 80, with higher scores denoting higher levels of state anxiety.
Measure: Change from baseline of the total score of the State Anxiety Inventory Time: up to 2 days pre-treatment and 1-2 days post-treatmentDescription: The PHQ-9 is a 9-item self-report scale for depression symptoms. Scores can range from 0 to 27, with higher scores reflecting more symptoms of depression.
Measure: Change from Baseline of the total score of the PHQ-9 Time: up to 2 days pre-treatment and 1-2 days post-treatmentDescription: The GAD-7 is a 7-item self-report scale for generalized anxiety symptoms. Scores can range from 0 to 21, with higher scores reflecting more symptoms of generalized anxiety.
Measure: Change from Baseline of the total score of the GAD-7 Time: up to 2 days pre-treatment and 1-2 days post-treatment5 Risk Factors for Anxiety and Depression Among Pregnant Women During the COVID-19 Pandemic - a Web-based Cross-sectional Survey
The article presents a protocol of a cross-sectional study of mental health of pregnant women in relation to the COVID 19 pandemic. The primary aim is to compare differences in anxiety and depression scores of pregnant women between countries affected by the COVID-19 pandemic. The secondary aim is to assess demographic, economic, and social aspects affecting maternal anxiety and depression scores among pregnant women worldwide in the time of the COVID-19 pandemic. Finally, investigators will be able to compare differences in perception of the different aspects of the COVID-19 pandemic (social distancing, restrictions related to delivery) between countries and according to the epidemic status (number of infected patients, number of reported deaths). The comparisons will also be done according to COVID-19 status of the participants.
NCT04377412 Anxiety Depression Pregnancy Related Other: Pandemic control measures MeSH:Depression Depressive Disorder Anxiety Disorders
HPO:Depressivity
Primary Outcomes
Description: Anxiety measured by General Anxiety Disorder-7 (GAD-7) scale. Scoring:5-9 mild; 10-14 moderate; >15 severe. Minimum 0, maximum 21 points
Measure: Anxiety Time: 4 months
Description: Depression measured by Patient Health Questionnaire-9 (PHQ-9) scale. Scoring: 5-9 mild;10-14 moderate; 15-19 moderately severe; >20 severe. Minimum 0 maximum 27 points
Measure: Depression Time: 4 months
6 ''(COVID-19) and Anxiety and Depressive Symptoms in Pregnant Women"
Primary Outcomes
Description: Anxiety measured by General Anxiety Disorder-7 (GAD-7) scale. Scoring:5-9 mild; 10-14 moderate; >15 severe. Minimum 0, maximum 21 points
Measure: Anxiety Time: 4 monthsDescription: Depression measured by Patient Health Questionnaire-9 (PHQ-9) scale. Scoring: 5-9 mild;10-14 moderate; 15-19 moderately severe; >20 severe. Minimum 0 maximum 27 points
Measure: Depression Time: 4 monthsIn our study; Anxiety and depression levels, socio-demographic characteristics of the pregnant women who were admitted to our hospital between 25.04.2020-25.07.2020 and treated with the diagnosis of covid 19, and the change in anxiety and depression levelsWİTH Beck Depression and Anxiety Score after the disease regressed are planned. (Beck depression scale contains 10 questions and a total of 1 to 100 points is obtained. High score indicates that depression and anxiety are high.) 0-16 points = mild depressive symptoms 17-29 points = moderate depressive symptoms 30-63 points = severe depressive symptoms
NCT04384887 COVID Anxiety Depression, Postpartum Behavioral: covid-19 positive pregnant women MeSH:Depression, Postpartum Depression Anxiety Disorders
Primary Outcomes
Description: Evaluation of depression and anxiety score changes of covid-19 positive pregnants Pregnant women are questioned how this period was affected, as the pandemic period loaded with extra stress and caused depression and anxiety.
Measure: Evaluation of depression and anxiety score changes of covid-19 positive pregnants Time: 4 months7 Determination of Stress and Anxiety Levels of Mothers Lying in the Newborn Intensive Care Unit During Coronavirus Disease Pandemic Period
Although coronaviruses (CoV) cause mild infections in the community, such as colds, they can also cause more severe infections. There are many subspecies of coronaviruses that can pass from animals to humans and can be transmitted between humans. One of these subspecies is COVID-19 (severe acute respiratory syndrome coronavirus 2), SARS-CoV-2, and has made a worldwide pandemic from the beginning of 2020. In this process, going out of the house, going to the hospital and being in the hospital brings with it the anxiety to get sick. In the period when the feeling of motherhood begins at the end of birth, the hospitalization of the baby for any reason and the separation of the mother and the baby can be an additional source of stress. This study was planned to determine the anxiety and anxiety levels of mothers who had a baby in the NICU during Coronavirus disease pandemic and the factors affecting them.
NCT04386798 Newborn Anxiety Other: survey work MeSH:Anxiety Disorders
Primary Outcomes
Description: During Coronavirus disease pandemic, anxiety rates of mothers lying on their babies in their NICUs were correlated with sociodemographic features.
Measure: Mothers' anxiety rate Time: 30 days8 Effects of Cognitive Behavariol Brief Therapy on Perceived Stress Level and Anxiety, Depression and Post Trauamatic Stress Symptoms in Medical Residents and Medical Staff During CoVID 19 Pandemics
The purpose of the study is to demonstrate the effect of brief behavarioul cognitive therapy through telepsychiatry.
NCT04394455 Anxiety Depressive Symptoms Post Traumatic Stress Symptoms Behavioral: Brief cognitive behavioural therapy Behavioral: Crisis intervention therapy MeSH:Depression Anxiety Disorders
Primary Outcomes
Description: Patient Health Questionnaire 9
Measure: Change in Depressive symptoms Time: 3 months after psychotherapeutic intervention has startedDescription: Hamilton Anxiety Rating Scale
Measure: Change in Anxiety symptoms Time: 3 months after psychotherapeutic intervention has startedDescription: Post traumatic Stress Scale for DSM 5
Measure: Change in Post traumatic Stress symptoms Time: 3 months after psychotherapeutic intervention has startedDescription: Perceived stress scale
Measure: Change in Perceived stress level Time: 3 months after psychotherapeutic intervention has started9 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 Stress Stress Disorder Stress, Psychological Trauma, Psychological Anxiety Anxiety State Post Traumatic Stress Disorder Secondary Traumatic Stress Professional Quality of Life Stress Related Disorder Stress Reaction Stress Risk Mental Resilience Emotional Resilience 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)10 Mental Health Support for SickKids Children and Families During COVID-19 Using Established eHealth Interventions
Coronavirus disease 2019 (COVID-19) and associated emergency measures (EM) have dramatically impacted the lives of children/adolescents (children) and families. The closure of schools, social and recreational activities, and modifications to work environments has led to significant changes in the way children and families are working, living and socializing. Although the impact on the mental health of children and families has not been well researched, it is anticipated that already stressed children and families with pre-COVID-19 mental health challenges are at significant risk for deterioration in their mental health. As such, the implementation, and evaluation (specifically: feasibility, acceptability and barriers) of virtual-care interventions to alleviate child and family anxiety and enhance family functioning are critical. Virtual-care also optimizes health equity initiatives in reducing social, economic and environmental barriers to services that can improve or maintain mental health (WHO, 2017; MOHLTC, 2018). The current study will evaluate an adapted virtual-care cognitive behavioural therapy (CBT) program for children with anxiety (VC-CBT). CBT has a strong evidence-base in treating children with anxiety disorders (Higa-McMillan, Francis, Rith-Najarian, and Chorpita, 2016; Seligman and Ollendick, 2011), with increasing evidence supporting the efficacy of virtual-care CBT for childhood anxiety disorders (Carpenter, Pincus, Furr, and Comer, 2018; Slone, Reese, and McClellan, 2012). This study aims to evaluate the feasibility, participation barriers related to social determinants of health (SDH) and acceptability of this virtual-care intervention in addressing mental health challenges associated with the COVID-19 pandemic and ensuing EM in the immediate time-period. Early evaluation of this virtual-care intervention will enable future scale-up of this intervention during the post-pandemic recovery time-period and during subsequent COVID-19 waves, if necessary.
NCT04408027 Anxiety Disorder of Childhood or Adolescence Behavioral: Virtual-Care Cognitive Behavioural Therapy MeSH:Anxiety Disorders
Primary Outcomes
Description: Participation barriers related to Social Determinants of Health (SDH) will be captured to assess intervention feasibility. Participation barriers will be captured using the Social Determinants of Health Questionnaire (unpublished).
Measure: Participation Barriers Time: The Social Determinants of Health Questionnaire will be administered at baseline only, for each participant (approximately one week prior to the first of twelve sessions in the intervention).Description: Number of participants that were eligible for the study.
Measure: Number of Eligible Participants Time: The number of participants that were eligible for the study will be captured through study completion, estimated at approximately 1 year.Description: Number of participants that were approached for the study.
Measure: Number of Participants Approached Time: The number of participants that were approached for the study will be captured through study completion, estimated at approximately 1 year.Description: Number of participants consented for the study.
Measure: Number of Participants Consented Time: The number of participants that were consented for the study will be captured through study completion, estimated at approximately 1 year.Description: Rates of refusal for participation in the study.
Measure: Rates of Refusal Time: The rates of refusal for participation in the study will be assessed through study completion, estimated at approximately 1 year.Description: Reasons for refusal for participation in the study.
Measure: Reasons for Refusal Time: The reasons of refusal for participation in the study will be assessed through study completion, estimated at approximately 1 year.Description: The average number of sessions completed in total will be captured to evaluate intervention adherence.
Measure: Number of Sessions Completed in Total Time: The average number of sessions completed in total, for each participant, will be assessed through study completion, estimated at approximately 1 year.Description: The adherence index (calculated using the formula: sessions completed/total sessions scheduled [sum of sessions attended, rescheduled, no-showed and cancelled]) will be used to evaluate intervention adherence.
Measure: Adherence Index Time: The adherence index, for each participant, will be assessed through study completion, estimated at approximately 1 year.Description: The amount of time (in weeks) to complete the intervention will be captured to evaluate intervention implementation experience.
Measure: Amount of time (in weeks) to complete the intervention Time: The amount of time (in weeks) to complete the intervention, for each participant, will be assessed through study completion, estimated at approximately 1 year.Description: The measure that will be used to assess the primary outcome of intervention acceptability is the Virtual Care Satisfaction Survey (Romanchych, unpublished).
Measure: Intervention Acceptability Time: The Virtual Care Satisfaction Survey will be administered once, within approximately one week after completion of the twelfth (final) intervention session (estimated to occur approximately 12 to 16 weeks after initiation of the study).Description: The measure that will be used to assess participant satisfaction is the Virtual Care Satisfaction Survey (Romanchych, unpublished).
Measure: Participant Satisfaction Time: The Virtual Care Satisfaction Survey will be administered once, within approximately one week after completion of the twelfth (final) intervention session (estimated to occur approximately 12 to 16 weeks after initiation of the study).Description: The Working Alliance Inventory will be used to assess participant satisfaction (WAI; Tracy & Kokotovic, 1989).
Measure: Working Alliance Inventory after First Intervention Session Time: The Working Alliance Inventory will be administered within approximately one week after completion of the first intervention session (estimated to occur approximately 1 to 2 weeks after initiation of the study).Description: The Working Alliance Inventory will be used to assess participant satisfaction (WAI; Tracy & Kokotovic, 1989).
Measure: Working Alliance Inventory after Sixth Intervention Session Time: The Working Alliance Inventory will be administered within approximately one week after completion of the sixth intervention session (estimated to occur approximately 6 to 8 weeks after initiation of the study).Description: The Working Alliance Inventory will be used to assess participant satisfaction (WAI; Tracy & Kokotovic, 1989).
Measure: Working Alliance Inventory after Final Intervention Session Time: The Working Alliance Inventory will be administered within approximately one week after completion of the twelfth (final) intervention session (estimated to occur approximately 12 to 16 weeks after initiation of the study).Secondary Outcomes
Description: Coronavirus disease 2019 (COVID-19) specific distress will be assessed using the CoRonavIruS Health Impact Survey (CRISIS; Merikangas et al., unpublished) V0.1 Parent/Caregiver or Youth Baseline Form. Many items from this scale address social determinants of health, which will allow for understanding of family social determinants of health at baseline and over the course of the virtual-care treatment.
Measure: Family Impact During a Pandemic at Baseline Time: CRISIS (parent/caregiver and youth forms) will be completed virtually by children and parents at baseline (approximately one week prior to the first of twelve sessions in the intervention).Description: Coronavirus disease 2019 (COVID-19) specific distress will be assessed using the CoRonavIruS Health Impact Survey (CRISIS; Merikangas et al., unpublished) V0.1 Parent/Caregiver or Youth Follow-Up Form. Many items from this scale address social determinants of health, which will allow for understanding of family social determinants of health at baseline and over the course of the virtual-care treatment.
Measure: Family Impact During a Pandemic after Final Intervention Session Time: CRISIS forms will be completed virtually by children and parents, within approximately one week of completion of the twelfth (final) intervention session (approximately 12 to 16 weeks after initiation of the study).Description: To evaluate the efficacy of the virtual-care CBT intervention, change in child anxiety will be measured using child and parent-report Screen for Child Anxiety Related Disorders (SCARED; Birmaher et al., 1997). The SCARED is a child and parent self-report instrument used to screen for childhood anxiety disorders including general anxiety disorder, separation anxiety disorder, panic disorder and social phobia. In addition, it assesses symptoms related to school phobia. A total score of 25 of higher on the SCARED measure may indicate the presence of an anxiety disorder. Scores higher than 30 are more specific.
Measure: Efficacy of Virtual-Care CBT Intervention Time: The SCARED questionnaire will be completed at both baseline and within approximately one week after completion of the twelfth (final) intervention session (estimated to occur approximately 12 to 16 weeks after study initiation).Description: In order to evaluate the experience of clinicians (at The Hospital for Sick Children (SickKids) and the Centre for Community Mental Health (CCMH)) using virtual-care platforms during the work from home shift due to COVID-19 and to identify any challenges they may be facing, a Clinician Virtual Care Experience Survey (Romanchych, unpublished) will be administered.
Measure: Clinician Virtual Care Experience Time: The Clinician Virtual Care Survey will be completed virtually by clinicians at both SickKids and CCMH at baseline.