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Addressing Stress Responses on the Frontline-Further Development of RESTORE (Recovering From Extreme Stressors Through Online Resources and E-health)
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.
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
Yes
UHN - Toronto General Hospital
Toronto, Ontario, Canada
Start Date
March 23, 2021
Primary Completion Date
September 8, 2021
Completion Date
November 5, 2021
Last Updated
November 5, 2021
21
ACTUAL participants
RESTORE: Recovering from Extreme Stressors Through Online Resources and E-health
BEHAVIORAL
Lead Sponsor
University Health Network, Toronto
Collaborators
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07478393