Ignite Creation Date:
2024-05-06 @ 4:07 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04873622
Status:
COMPLETED
Last Update Posted:
2021-11-05
First Post:
2021-04-22
Brief Title:
Further Development and Initial Testing of RESTORE in Frontline Workers
Sponsor:
University Health Network Toronto
Organization:
University Health Network Toronto
Study Overview
Official Title:
Addressing Stress Responses on the Frontline-Further Development of RESTORE Recovering From Extreme Stressors Through Online Resources and E-health
Status:
COMPLETED
Status Verified Date:
2021-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RESTORE
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 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None