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

Post Traumatic Stress Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05553249
• Other study ID #: HS25632 (H2022:260)
• Status: Enrolling by invitation
• Start date: November 14, 2022
• Est. completion date: August 2024

Study information

• Verified date: July 2023
• Source: University of Manitoba
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 80
• Est. completion date: August 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Post Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Behavioral:
• Written Exposure Therapy
Virtual, group-based Written Exposure Therapy

Locations

Country	Name	City	State
Canada	Deer Lodge Centre	Winnipeg	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
University of Manitoba

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment acceptability	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	Attrition	Rate of participant attrition from the treatment program	5 weeks
Secondary	Change in PTSD symptoms	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
Secondary	Psychotherapy progress	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
Secondary	Change in depression symptoms	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