Group Written Exposure Therapy for Posttraumatic Stress Disorder (GWET)

Investigating Group Written Exposure Therapy for Posttraumatic Stress Disorder: A Pilot Study

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.

Study Overview

• Status: Recruiting
• Conditions: Posttraumatic Stress Disorder
• Intervention / Treatment: Behavioral: Group Written Exposure Therapy

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 Type: Interventional
• Enrollment (Estimated): 63
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jenna Boyd, Ph.D.; Phone Number: 32749 905-522-1155; Email: boydj@stjosham.on.ca

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8R2Y2
      • Recruiting
      • Anxiety Treatment and Research Clinic, St. Joseph's Healthcare Hamilton
      • Contact: Jenna Boyd, PhD; Phone Number: 32749 905-522-1155; Email: boydj@stjoes.ca
      • Principal Investigator: Jenna Boyd, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Between the ages of 18 and older
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline on the PTSD Checklist for DSM-5 (PCL-5)	20-item self-report questionnaire assessing symptoms of PTSD over the past week.	Weekly at each group session, 1 week before treatment begins, 1 week after treatment ends, and 1-month follow-up.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline on the Posttraumatic Cognitions Inventory (PTCI)	36-item self-report questionnaire assessing negative beliefs across three subscales: negative cognitions about the self, negative cognitions about the world, and self-blame.	1 week before treatment begins, 1 week after treatment ends, and 1-month follow-up.
Change from baseline on the Depression, Anxiety, Stress Scale -21 Item Version (DASS-21)	21-item self-report measure with three subscales measuring depression, anxiety, and stress symptoms.	1 week before treatment begins, 1 week after treatment ends, and 1-month follow-up.
Change from baseline on the Difficulties in Emotion Regulation Scale (DERS)	36-item self-report measure assessing emotion regulation difficulties.	1 week before treatment begins, 1 week after treatment ends, and 1-month follow-up.
Change from baseline on the Illness Intrusiveness Rating Scale (IIRS)	13-item self-report measure assessing the effect of illness on domains of quality of life.	1 week before treatment begins, 1 week after treatment ends, and 1-month follow-up.
Group Cohesion Scale-Revised (GCS-R)	Self-report measure assessing group member's perception of their group and the strength of the bonds formed.	1 week after treatment ends.

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Weathers, F.W., Litz, B.T., Keane, T.M., Palmieri, P.A., Marx, B.P., & Schnurr, P.P. (2013). The PTSD Checklist for DSM-5 (PCL-5). Scale available from the National Center for PTSD at www.ptsd.va.gov.
• Sloan DM, Marx BP, Resick PA, Young-McCaughan S, Dondanville KA, Straud CL, Mintz J, Litz BT, Peterson AL; STRONG STAR Consortium. Effect of Written Exposure Therapy vs Cognitive Processing Therapy on Increasing Treatment Efficiency Among Military Service Members With Posttraumatic Stress Disorder: A Randomized Noninferiority Trial. JAMA Netw Open. 2022 Jan 4;5(1):e2140911. doi: 10.1001/jamanetworkopen.2021.40911.
• Sloan, D.M., & Marx, B.P. (2019). Written exposure therapy for PTSD: A brief treatment approach for mental health professionals. American Psychological Association.
• Gratz, K. L., & Roemer, L. (2004). Multidimensional assessment of emotion regulation and dysregulation: Development, factor structure, and initial validation of the difficulties in emotion regulation scale. Journal of Psychopathology and Behavioral Assessment, 26, 41-54.
• Antony, M.M., Bieling, P.J., Cox, B.J., Enns, M.W., & Swinson, R.P. (1998). Psychometric properties of the 42-item and 21-item versions of the Depression Anxiety Stress Scales in clinical groups and a community sample. Psychological Assessment, 10(2), 176-181.
• Foa, E.B., Ehlers, A., Clark, D.M., Tolin, D.F., & Orsillo, S.M. (1999). The Posttraumatic Cognitions Inventory (PTCI): Development and validation. Psychological Assessment, 11(3), 303-314.
• Devins GM. Using the illness intrusiveness ratings scale to understand health-related quality of life in chronic disease. J Psychosom Res. 2010 Jun;68(6):591-602. doi: 10.1016/j.jpsychores.2009.05.006. Epub 2009 Jul 17.
• Treadwell, T., Lavertue, N., Kumar, V. K., & Veeraraghavan, V. (2001). The Group Cohesion Scale-Revised: Reliability and validity. International Journal of Action Methods: Psychodrama, Skill Training, and Role Playing, 54(1), 3-12.

Study record dates

Study Major Dates

• Study Start (Actual): May 9, 2023
• Primary Completion (Estimated): May 9, 2025
• Study Completion (Estimated): May 9, 2025

Study Registration Dates

• First Submitted: January 27, 2023
• First Submitted That Met QC Criteria: February 6, 2023
• First Posted (Actual): February 15, 2023

Study Record Updates

• Last Update Posted (Actual): April 17, 2024
• Last Update Submitted That Met QC Criteria: April 15, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: cognitive behavioural therapy; posttraumatic stress disorder; group therapy; written exposure therapy
• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: 15477

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No