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RESTORE intervention for Mental Health

N/A
Waitlist Available
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, pre-intervention; during the intervention (after module 4); immediately after the intervention; 1-month follow-up
Awards & highlights

Study 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.

Eligible Conditions
  • Mental Health
  • Post-Traumatic Stress Disorder
  • Anxiety
  • Depression

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, pre-intervention; during the intervention (after module 4); immediately after the intervention; 1-month follow-up
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, pre-intervention; during the intervention (after module 4); immediately after the intervention; 1-month follow-up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Generalized Anxiety Disorder-7 (GAD-7)
Change in Patient Health Questionnaire-9 (PHQ-9)
Change in self-reported Post Traumatic Stress Disorder (PTSD) symptoms
Secondary outcome measures
Change in Adapted Brief Grief Questionnaire
Change in Mental Health Seeking Attitudes/Intention Scale
Change in Perceived Health, Functioning, and Quality of Life (QOL)
+2 more
Other outcome measures
Client Satisfaction Questionnaire
Eligibility and enrolment rates
Intervention adherence
+2 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: RESTORE interventionExperimental Treatment1 Intervention
Participants who screen eligible and consent will receive RESTORE with guidance.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
RESTORE: Recovering from Extreme Stressors Through Online Resources and E-health
2021
N/A
~30

Find a Location

Who is running the clinical trial?

Ryerson UniversityOTHER
76 Previous Clinical Trials
7,879 Total Patients Enrolled
University Health Network, TorontoLead Sponsor
1,468 Previous Clinical Trials
484,470 Total Patients Enrolled
1 Trials studying Mental Health
21 Patients Enrolled for Mental Health
Toronto Metropolitan UniversityOTHER
83 Previous Clinical Trials
10,897 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
Journal of General Internal MedicineJournal
The PHQ-9
Kroenke, Kurt, Robert L. Spitzer, and Janet B. W. Williams. 2001. “The PHQ-9”. Journal of General Internal Medicine. Springer Science and Business Media LLC. doi:10.1046/j.1525-1497.2001.016009606.x.
Evaluation and Program PlanningJournal
The Client Satisfaction Questionnaire
Attkisson, C.Clifford, and Rebecca Zwick. 1982. “The Client Satisfaction Questionnaire”. Evaluation and Program Planning. Elsevier BV. doi:10.1016/0149-7189(82)90074-x.
Canadian Medical Association JournalJournal
Optimal Cut-off Score for Diagnosing Depression with the Patient Health Questionnaire (PHQ-9): A Meta-analysis
Manea, Laura, Simon Gilbody, and Dean McMillan. 2011. “Optimal Cut-off Score for Diagnosing Depression with the Patient Health Questionnaire (PHQ-9): A Meta-analysis”. Canadian Medical Association Journal. CMA Joule Inc.. doi:10.1503/cmaj.110829.
Archives of Internal MedicineJournal
A Brief Measure for Assessing Generalized Anxiety Disorder
Spitzer, Robert L., Kurt Kroenke, Janet B. W. Williams, and Bernd Löwe. 2006. “A Brief Measure for Assessing Generalized Anxiety Disorder”. Archives of Internal Medicine. American Medical Association (AMA). doi:10.1001/archinte.166.10.1092.
~6 spots leftby Apr 2025
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