Recruiting

Observational Study

Sponsor:

University Health Network, Toronto

Code:

NCT04958902

Conditions

Mental Health

PTSD

Anxiety

Depressive Symptoms

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

RESTORE: Recovering from Extreme Stressors Through Online Resources and E-health

Study Details

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.

Conditions

Mental Health

PTSD

Anxiety

Depressive Symptoms

Study ID

NCT04958902

Start date

Oct 22, 2021

Status verified date

Nov, 2021

Completion date

Nov 1, 2021

Anticipated

Primary completion date

Nov 1, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: RESTORE intervention

Participants who screen eligible and consent will receive RESTORE with guidance.

Interventions

RESTORE: Recovering from Extreme Stressors Through Online Resources and E-health

RESTORE (www.restoreonline.ca) includes eight e-modules anticipated to be approximately 30-40 minutes each in length and intended to be completed over 4-8 weeks. The modules address cognitive and behavioural factors posited to cause and maintain psychological distress related to the COVID-19 pandemic. These include cognitions about the cause and meaning of stressors related to the pandemic, including self-blame, other blame and hindsight bias, as well as problematic beliefs related to safety, trust, and control. The modules also address the importance of: (1) expressing emotions that are natural to the events of the pandemic (e.g., sadness in the face of loss), (2) working through, rather than avoiding, thoughts, feelings and grief related to the pandemic, and (3) utilizing social supports. The modules consist of written materials, brief videos, and practice assignments delivered through the platform. RESTORE includes guidance via direct messaging and/or brief telephone calls.

Primary outcome measure

  • Change in self-reported Post Traumatic Stress Disorder (PTSD) symptoms [ Time Frame: Baseline, pre-intervention; during the intervention (after module 4); immediately after the intervention; 1-month follow-up ]
  • Change in Generalized Anxiety Disorder-7 (GAD-7) [ Time Frame: Baseline, pre-intervention; during the intervention (after module 4); immediately after the intervention; 1-month follow-up ]
  • Change in Patient Health Questionnaire-9 (PHQ-9) [ Time Frame: Baseline, pre-intervention; during the intervention (after module 4); immediately after the intervention; 1-month follow-up ]

Central Contacts and Locations

Central contacts

Kathryn Trottier, PhD

4163404800kathryn.trottier@uhn.ca

Candice Monson, PhD

candice.monson@ryerson.ca

Locations

University Health Network

Recruiting

Toronto, Ontario, Canada

More Information

Sponsor

University Health Network, Toronto

Last update posted

Nov 5, 2021

Last verified

Nov, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2021-11-05.