GWET: Group Written Exposure Therapy for Posttraumatic Stress Disorder

Sponsor
St. Joseph's Healthcare Hamilton (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05729789
Collaborator
(none)
63
1
24

Study Details

Study Description

Brief Summary

The goal of this clinical trial is to test if Written Exposure Therapy (WET) works well in a group setting in patients with post-traumatic stress disorder (PTSD).

The main questions it aims to answer are:
  • Does group WET lead to a reduction in symptoms of PTSD?

  • Is group WET better at reducing the number of patients that drop out of treatment in comparison to group Cognitive Processing Therapy (CPT)?

Participants will:
  • Attend 6 weekly sessions of group WET that will be delivered online by two therapists (psychologist and social worker)

  • Complete questionnaires relating to their symptoms at different points throughout the treatment

Researchers will evaluate change in PTSD symptoms over time for people who participate in group WET. They will also compare the results of group WET to the results of group CPT to see if group WET shows a similar reduction in symptoms of PTSD and fewer treatment drop-outs.

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

Detailed Description

The primary objective of this study is to evaluate the effectiveness of group WET (G-WET) in reducing symptoms of PTSD in an outpatient hospital setting. In order to do so, we will evaluate outcomes of G-WET from pre- to post-treatment and at one month follow-up. We will also compare outcomes of G-WET to published benchmarks of individual WET outcomes and to a representative cohort of individuals who participate in group CPT at our clinic. A secondary aim of the study is to evaluate attendance and drop-out rates for group WET. In order to achieve this, we will recruit a sample of 63 individuals between the ages of 18 and 65 to participate in a group WET 6-session protocol (1 orientation session and 5 WET sessions) from an outpatient anxiety and related disorders clinic waitlist for group CPT. Participants will complete measures assessing PTSD, related symptoms (e.g., depression, anxiety) and group cohesion at pre-treatment, post-treatment, and 1-month follow-up. Attendance and drop-out rates will also be recorded. We hypothesize that group WET will be associated with significant reductions in PTSD symptoms and related symptoms and low dropout rates (i.e., less than 10%). We also hypothesize that outcomes for group WET will be comparable to those for group CPT and published individual WET benchmarks.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
63 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Investigating Group Written Exposure Therapy for Posttraumatic Stress Disorder: A Pilot Study
Anticipated Study Start Date :
May 9, 2023
Anticipated Primary Completion Date :
May 9, 2025
Anticipated Study Completion Date :
May 9, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group Written Exposure Therapy

Patients will be invited to participate in group Written Exposure Therapy (described in the "Interventions" section).

Behavioral: Group Written Exposure Therapy
Group Written Exposure Therapy (GWET) is a brief cognitive behavioural therapy for PTSD aimed at allowing patients to process their traumatic experiences in a safe environment. GWET will consist of 6 group sessions (1 orientation session and 5 weekly group sessions). Participants will be asked to complete weekly in-session written exposures where they will recount their traumatic experience. The written exposure will be followed by a guided discussion about the experience of writing the exposure. There is no homework assigned between sessions. However, group members will be asked to refrain from avoiding thinking about the trauma between sessions.

Outcome Measures

Primary Outcome Measures

  1. Change from baseline on the PTSD Checklist for DSM-5 (PCL-5) [Weekly at each group session, 1 week before treatment begins, 1 week after treatment ends, and 1-month follow-up.]

    20-item self-report questionnaire assessing symptoms of PTSD over the past week.

Secondary Outcome Measures

  1. Change from baseline on the Posttraumatic Cognitions Inventory (PTCI) [1 week before treatment begins, 1 week after treatment ends, and 1-month follow-up.]

    36-item self-report questionnaire assessing negative beliefs across three subscales: negative cognitions about the self, negative cognitions about the world, and self-blame.

  2. Change from baseline on the Depression, Anxiety, Stress Scale -21 Item Version (DASS-21) [1 week before treatment begins, 1 week after treatment ends, and 1-month follow-up.]

    21-item self-report measure with three subscales measuring depression, anxiety, and stress symptoms.

  3. Change from baseline on the Difficulties in Emotion Regulation Scale (DERS) [1 week before treatment begins, 1 week after treatment ends, and 1-month follow-up.]

    36-item self-report measure assessing emotion regulation difficulties.

  4. Change from baseline on the Illness Intrusiveness Rating Scale (IIRS) [1 week before treatment begins, 1 week after treatment ends, and 1-month follow-up.]

    13-item self-report measure assessing the effect of illness on domains of quality of life.

  5. Group Cohesion Scale-Revised (GCS-R) [1 week after treatment ends.]

    Self-report measure assessing group member's perception of their group and the strength of the bonds formed.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Between the ages of 18 and 65 years, inclusive

  • Diagnosis of PTSD

  • Able to provide written informed consent and can read and write in English

Exclusion Criteria:
  • Diagnosis of an active severe substance use disorder (SUD)

  • Diagnosis of a psychotic disorder (schizophrenia, schizoaffective disorder, etc.)

  • Untreated active psychotic, manic or hypomanic symptoms

  • Has attempted suicide in the 2 months prior to beginning treatment

  • Has engaged in high-risk self-harm (e.g., cutting, burning, asphyxiation) in the 2 months prior to beginning treatment

  • Has completed CPT in the past

  • Has completed another active PTSD treatment, such as Prolonged Exposure or EMDR within the last year

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • St. Joseph's Healthcare Hamilton

Investigators

  • Principal Investigator: Jenna Boyd, Ph.D., St. Joseph's Healthcare Hamilton

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Jenna Boyd, Dr. Jenna Boyd, St. Joseph's Healthcare Hamilton
ClinicalTrials.gov Identifier:
NCT05729789
Other Study ID Numbers:
  • 15477
First Posted:
Feb 15, 2023
Last Update Posted:
Feb 15, 2023
Last Verified:
Feb 1, 2023
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
Keywords provided by Jenna Boyd, Dr. Jenna Boyd, St. Joseph's Healthcare Hamilton
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 15, 2023