Clinical trial NCT04958902: RESTORE in Patients Who Had COVID-19 and Close Others
Official title: RESTORE: An Online Self-directed Mental Health Intervention for Individuals Who Had COVID-19 and Close Others
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mental Health
PTSD
Anxiety
Depressive Symptoms
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Toronto Metropolitan University
First posted: 2021-07-12
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

Eligibility criteria: 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

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

Primary outcomes:
measure: Change in self-reported Post Traumatic Stress Disorder (PTSD) symptoms
timeFrame: Baseline, pre-intervention; during the intervention (after module 4); immediately after the intervention; 1-month follow-up
measure: Change in Generalized Anxiety Disorder-7 (GAD-7)
timeFrame: Baseline, pre-intervention; during the intervention (after module 4); immediately after the intervention; 1-month follow-up
measure: Change in Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Baseline, pre-intervention; during the intervention (after module 4); immediately after the intervention; 1-month follow-up
Secondary outcomes:
measure: Change in Perceived Health, Functioning, and Quality of Life (QOL)
timeFrame: Baseline, pre-intervention; during the intervention (after module 4); immediately after the intervention; 1-month follow-up
measure: Change in Trauma-Related Guilt Inventory (TRGI)
timeFrame: Baseline, pre-intervention; during the intervention (after module 4); immediately after the intervention; 1-month follow-up
measure: Change in Adapted Brief Grief Questionnaire
timeFrame: Baseline, pre-intervention; during the intervention (after module 4); immediately after the intervention; 1-month follow-up
measure: Change in Perceived emotional social support
timeFrame: Baseline, pre-intervention; during the intervention (after module 4); immediately after the intervention; 1-month follow-up
measure: Change in Mental Health Seeking Attitudes/Intention Scale
timeFrame: Baseline, pre-intervention; during the intervention (after module 4); immediately after the intervention; 1-month follow-up
Other outcomes:
measure: Qualitative interviews
timeFrame: Immediately after the intervention
measure: Eligibility and enrolment rates
timeFrame: From screening through to study enrolment.
measure: Intervention adherence
timeFrame: Immediately after the intervention
measure: Intervention engagement
timeFrame: Immediately after the intervention
measure: Client Satisfaction Questionnaire
timeFrame: Immediately after the intervention
Locations:
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
Study officials:
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