Clinical trial NCT04873622: Further Development and Initial Testing of RESTORE in Frontline Workers
Official title: Addressing Stress Responses on the Frontline-Further Development of RESTORE (Recovering From Extreme Stressors Through Online Resources and E-health)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Health
PTSD
Anxiety
Depressive Symptoms
Keywords: eHealth intervention
COVID-19
mental health
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Canadian Department of Defence
name: University Health Network Foundation
First posted: 2021-05-05
Enrollment: 21
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 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.

Eligibility criteria: Inclusion Criteria:

* Canadian healthcare worker, first responder, or military member
* Experienced a traumatic or extremely stressful situation in the course of work related to COVID-19
* ≥ 18 years of age
* Scores at above clinical threshold, as defined by the investigators, 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 Adapted Expressions of Moral Injury Scale
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: Feasibility of recruitment
timeFrame: After 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: UHN - Toronto General Hospital
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Kathryn Trottier, PhD
role: PRINCIPAL_INVESTIGATOR
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citation: Trottier K, Monson CM, Kaysen D, Wagner AC, Liebman RE, Abbey SE. Initial findings on RESTORE for healthcare workers: an internet-delivered intervention for COVID-19-related mental health symptoms. Transl Psychiatry. 2022 Jun 1;12(1):222. doi: 10.1038/s41398-022-01965-3.