Group Written Exposure Therapy for Posttraumatic Stress Disorder

Posttraumatic Stress Disorder Clinical Trial

— GWET  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05729789
• Other study ID #: 15477
• Status: Recruiting
• Phase: N/A
• Start date: May 9, 2023
• Est. completion date: May 9, 2025

Study information

• Verified date: April 2024
• Source: St. Joseph's Healthcare Hamilton
• Contact: Jenna Boyd, Ph.D.
• Phone: 905-522-1155
• Email: boydj[@]stjosham.on.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 63
• Est. completion date: May 9, 2025
• Est. primary completion date: May 9, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
Canada	Anxiety Treatment and Research Clinic, St. Joseph's Healthcare Hamilton	Hamilton	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
St. Joseph's Healthcare Hamilton

Country where clinical trial is conducted

Canada, 

References & Publications (8)

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.

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. — View Citation

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.

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.

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. — View Citation

Sloan, D.M., & Marx, B.P. (2019). Written exposure therapy for PTSD: A brief treatment approach for mental health professionals. American Psychological Association.

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.

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.