NCT04873622

Further Development and Initial Testing of RESTORE in Frontline Workers

Addressing Stress Responses on the Frontline-Further Development of RESTORE (Recovering From Extreme Stressors Through Online Resources and E-health)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: University Health Network, Toronto · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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 feasibility, initial safety, and efficacy of RESTORE for addressing mental health symptoms in first responders, health care workers (HCW), and Canadian Armed Forces members exposed to COVID-19-related traumatic or extreme stressors.

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 and manualized 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 from baseline to post-intervention. 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.

Conditions

• Mental Health
• PTSD
• Anxiety
• Depressive Symptoms

Interventions

Type	Name	Description
BEHAVIORAL	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.

Timeline

• Start date: 2021-03-23
• Primary completion: 2021-09-08
• Completion: 2021-11-05
• First posted: 2021-05-05
• Last updated: 2021-11-05

Locations

1 site across 1 country: Canada