- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05553249
Written Exposure Therapy for PTSD in a Virtual, Group-based Format
Written Exposure Therapy for PTSD: A Pilot Study of a Virtually Delivered Group-Based Intervention
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study will assess the efficacy and acceptability of WET being delivered virtually and in a group format for the treatment of PTSD through the Operational Stress Injury Clinic (OSIC) at Deer Lodge Centre.
WET is offered in small groups of 10 patients. This study will follow 8 iterations of the group for a potential total of 80 participants in this study. Each WET group session will be facilitated by two OSIC clinicians, at least one of whom will be a clinical psychologist. Each session, administered via the Zoom app for healthcare, will start with a brief check in, then instructions will be provided to the whole group. Each group will receive a total of 5 therapy sessions, each of which will last approximately 1.5hrs.
Prior to the first WET session, participants will be asked to complete three clinical measures: Patient Health Questionnaire- 9 (PHQ-9), PTSD Checklist for DSM-5 (PCL-5, weekly version), and Outcome Questionnaire-45 (OQ-45). Participants will be asked to complete the PCL-5 prior to each session. Participants will also complete a Treatment Acceptability/Adherence Scale prior to the start of the second session.
Following the final session of therapy, participants will be asked to complete the three clinical assessment questionnaires (PHQ-9, PCL-5, and OQ-45) at 1 week, 1 month, and 3 months post-treatment. A research assistant will also follow-up with each participant at the 3-month mark to ask whether they have sought or attended further psychological treatment since the end of the WET sessions.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Manitoba
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Winnipeg, Manitoba, Canada, R3J 0L3
- Deer Lodge Centre
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Referred for Written Exposure Therapy at the Occupational Stress Injury Clinic (OSIC) in Winnipeg
- Able to speak, read, and write in English
- Medication held at a stable dose for four weeks prior to beginning treatment and throughout the duration of treatment (if on a prescribed medication)
Exclusion Criteria:
- Current psychosis
- Presence of another psychiatric disorder that requires prioritization over treating PTSD
- Any cognitive, visual, or motor impairment that would prevent writing for 30 minutes
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Treatment acceptability
Time Frame: 5 weeks
|
Acceptability of the treatment program based on responses to the Treatment Acceptability/Adherence Scale.
Scores on this scale range from 10-70 with higher scores indicating greater acceptability.
|
5 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Attrition
Time Frame: 5 weeks
|
Rate of participant attrition from the treatment program
|
5 weeks
|
|
Change in PTSD symptoms
Time Frame: 5 weeks
|
Change in PTSD symptom severity based on the Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5).
Scores on this scale range from 0-80 with higher scores indicating greater symptom severity.
|
5 weeks
|
|
Psychotherapy progress
Time Frame: 5 weeks
|
Psychotherapy progress as measured by the Outcome Questionnaire 45 (OQ-45).
A total score of all subscales ranges from 0 to 180, with higher scores indicating more severe distress and functional impairment.
|
5 weeks
|
|
Change in depression symptoms
Time Frame: 5 weeks
|
Change in depression symptoms based on the Patient Health Questionnaire-9 (PHQ-9).
Scores on this scale range from 0-27, with higher scores indication more severe depression.
|
5 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Carmen Bodkyn, PhD CPsych, University of Manitoba
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HS25632 (H2022:260)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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