Written Exposure Therapy for PTSD in a Virtual, Group-based Format

Sponsor
University of Manitoba (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05553249
Collaborator
(none)
80
1
20.6
3.9

Study Details

Study Description

Brief Summary

The purpose of this study is to examine whether Written Exposure Therapy (WET) can be effectively delivered virtually and in a group format for the treatment of Post-Traumatic Stress Disorder in a military and police population. The objective of this study is to assess treatment feasibility and acceptability, drop out rates, changes in severity of trauma-related symptoms and symptoms of depression, quality of life, and the need for further trauma-focused treatment (TFT) for the the delivery of WET as a virtual, group based intervention.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Written Exposure Therapy

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 Design

Study Type:
Observational
Anticipated Enrollment :
80 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Written Exposure Therapy for PTSD: A Pilot Study of a Virtually Delivered Group-Based Intervention
Actual Study Start Date :
Nov 14, 2022
Anticipated Primary Completion Date :
Apr 1, 2024
Anticipated Study Completion Date :
Aug 1, 2024

Outcome Measures

Primary Outcome Measures

  1. Treatment acceptability [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.

Secondary Outcome Measures

  1. Attrition [5 weeks]

    Rate of participant attrition from the treatment program

  2. Change in PTSD symptoms [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.

  3. Psychotherapy progress [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.

  4. Change in depression symptoms [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Deer Lodge Centre Winnipeg Manitoba Canada R3J 0L3

Sponsors and Collaborators

  • University of Manitoba

Investigators

  • Principal Investigator: Carmen Bodkyn, PhD CPsych, University of Manitoba

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Manitoba
ClinicalTrials.gov Identifier:
NCT05553249
Other Study ID Numbers:
  • HS25632 (H2022:260)
First Posted:
Sep 23, 2022
Last Update Posted:
Nov 18, 2022
Last Verified:
Sep 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 18, 2022