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Completed

NCT Number: NCT05553249

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

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.

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Key information

Conditions

Post Traumatic Stress Disorder Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Deer Lodge Centre

Winnipeg, Manitoba, R3J 0L3, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Written Exposure Therapy

Behavioral

Virtual, group-based Written Exposure Therapy

Primary outcomes

  1. 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.

Secondary outcomes

  1. Attrition

    Time frame: 5 weeks

    Rate of participant attrition from the treatment program

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

University of Manitoba

Other

Registry information

Official study title

Written Exposure Therapy for PTSD: A Pilot Study of a Virtually Delivered Group-Based Intervention

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Sep 23, 2022
Registry last updated
Sep 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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