RESTORE in Patients Who Had COVID-19 and Close Others

Not Applicable

• Conditions: Mental Health; Anxiety; Depressive Symptoms; PTSD

• Registration Number: NCT04958902
• Lead Sponsor: University Health Network, Toronto

Brief Summary

There is considerable need for psychological intervention targeting stressor-related mental health symptoms related to COVID-19. The investigators have developed an online self-directed transdiagnostic intervention to address this need called RESTORE: Recovering from Extreme Stressors Through Online Resources and E-health. The specific aims of this project are to refine and investigate the initial safety, efficacy, and desirability of RESTORE for addressing mental-health symptoms in individuals who have recovered from severe COVID-19 and close others.

Detailed Description

This uncontrolled pilot interventional study will examine the feasibility and preliminary efficacy of RESTORE. RESTORE is a guided self-directed online intervention to improve anxiety, depression, and posttraumatic stress disorder (PTSD) in individuals exposed to COVID-19 related traumatic or extreme stressors. RESTORE is based on evidence-based psychotherapies and has been designed to overcome many of the barriers associated with accessing evidence-based psychotherapies. The intervention will be iteratively refined over the course of the study. The guidance methods will also be refined over the course of the study

The primary hypotheses are that RESTORE will be safe, feasible, and desirable to participants, and will lead to improvements in mental health symptom severity from baseline to post-intervention. Secondary hypotheses are that RESTORE will lead to significant improvements in perceived health, quality of life, and functioning that will be maintained at one-month follow-up. Participants will be assessed at baseline, pre-intervention, during the intervention (after module 4), immediately after the intervention, and 1 month after completion of the intervention.

Study Timeline

• Study First Submitted: 2021-07-08
• Study First Submitted QC: 2021-07-09
• Study First Posted: 2021-07-12
• Study Start: 2021-10-22
• Status Verified: 2021-11
• Primary Completion: 2021-11-01
• Study Completion: 2021-11-01
• Last Update Submitted: 2021-11-04
• Last Update Posted: 2021-11-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Experienced a traumatic or extremely stressful experience related to being COVID-19+ or having a close other who was COVID-19+
• Participants who were COVID+ will be eligible once they are no longer exhibiting COVID-19 symptoms and those who were hospitalized will be eligible post-discharge
• Close others will be eligible once their close other with COVID-19 has recovered or if their loved one is deceased
• ≥ 18 years of age
• Scores at above clinical threshold on at least one of: Patient Health Questionnaire-9 ([PHQ-9] score ≥ 10), Generalized Anxiety Disorder Scale-7 ([GAD-7] score ≥ 10), and/or Posttraumatic Stress Disorder Scale-5 ([PCL-5] score ≥ 33)
• Access to a computer or a tablet with high speed internet access, be able to clearly see the screen of a computer or tablet, and be fluent in English
• Ability to provide consent

Read More

Exclusion Criteria

• Elevated risk of suicide
• Currently enrolled in another intervention or treatment (e.g., cognitive behavioural therapy) for stress responses related to the COVID-19 pandemic

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change in Generalized Anxiety Disorder-7 (GAD-7)	Baseline, pre-intervention; during the intervention (after module 4); immediately after the intervention; 1-month follow-up	A brief clinical measure to assess anxiety severity. Each item is rated on a 4-point scale from 0 (not at all) to 3 (nearly every day). A symptom severity score is calculated based on the sum of the 7 items, with scores ranging from 0 to 21. GAD-7 scores of 10 and 15 are the cut-off points for moderate and severe anxiety, respectively (Spitzer et., 2006).
Change in self-reported Post Traumatic Stress Disorder (PTSD) symptoms	Baseline, pre-intervention; during the intervention (after module 4); immediately after the intervention; 1-month follow-up	The PTSD Checklist-5 (PCL-5); Weathers, Litz, Keane, Palemeri, Marx, \& Schnurr, 2013) weekly version will provide a measure of change in self-reported PTSD symptoms over the course of intervention. Items are rated from 0 (not at all) to 4 (extremely). Items are summed to create a total score ranging from 0 to 80. A cutoff score of ≥ 33 can be used for screening for PTSD diagnosis (Weathers et al, 2013).
Change in Patient Health Questionnaire-9 (PHQ-9)	Baseline, pre-intervention; during the intervention (after module 4); immediately after the intervention; 1-month follow-up	A self-report measure of depression symptoms. Each of the 9 items is rated on a 4-point scale, ranging from 0 (not at all) to 3 (nearly every day). Items are summed to produce a total severity score ranging from 0 to 27, with higher scores indicating greater symptom severity. PHQ-9 scores ≥ 10 are considered indicative of moderate levels of depression (Manea et al., 2011).

Secondary Outcome Measures

Name	Time	Method
Change in Trauma-Related Guilt Inventory (TRGI)	Baseline, pre-intervention; during the intervention (after module 4); immediately after the intervention; 1-month follow-up	The TRGI is a 32-item self-report questionnaire designed to measure guilt experienced as a result of surviving a traumatic event. The inventory includes three scales: guilt cognitions, distress, and global guilt scales.
Change in Mental Health Seeking Attitudes/Intention Scale	Baseline, pre-intervention; during the intervention (after module 4); immediately after the intervention; 1-month follow-up	The Mental Health Seeking Attitudes/Intention Scale is an adapted 3-item measure to assess attitudes toward seeking help from a mental health professional (Hammer, Parent, \& Spiker, 2018). Each of the items is rated on a 7-point scale, ranging from 1 (definitely false) to 7 (definitely true).
Change in Adapted Brief Grief Questionnaire	Baseline, pre-intervention; during the intervention (after module 4); immediately after the intervention; 1-month follow-up	The Adapted Brief Grief Questionnaire is a 5-item self-report measure for screening for complicated grief (Shear et al., 2006). The items deal with difficulty accepting the death, interference in current life, troubling thoughts related to the death, avoidance of reminders of the loss, and feeling distant from others. Each item is scored from 0 to 2 (0 = not at all, 1 = somewhat, 2 = a lot).
Change in Perceived Health, Functioning, and Quality of Life (QOL)	Baseline, pre-intervention; during the intervention (after module 4); immediately after the intervention; 1-month follow-up	Single items will be used to measure perceived health, work functioning, and quality of life over the past month. Each item is rated on a 5-point scale, ranging from 1 (not at all satisfied/poor) to 5 (extremely satisfied/excellent).
Change in Perceived emotional social support	Baseline, pre-intervention; during the intervention (after module 4); immediately after the intervention; 1-month follow-up	Perceived Emotional Social Support is a single item measure of emotional of social support received in the past week from family and friends (Stappenbeck et al., 2015). The item is rated on a 5-point Likert scale, with responses ranging from 1 (strongly disagree) to 5 (strongly agree).

Trial Locations

Locations (1)

University Health Network; 🇨🇦 Toronto, Ontario, Canada