Group Written Exposure Therapy for Posttraumatic Stress Disorder

NCT05729789 | Recruiting

• 1 other identifier: 15477
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

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.

Conditions

Posttraumatic Stress Disorder

Keywords

cognitive behavioural therapy; written exposure therapy; group therapy; posttraumatic stress disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Change from baseline on the Posttraumatic Cognitions Inventory (PTCI)

  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)

  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)

  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)

  1 week before treatment begins, 1 week after treatment ends, and 1-month follow-up.

• Group Cohesion Scale-Revised (GCS-R)

  1 week after treatment ends.

Study Arms (1)

Group Written Exposure Therapy

EXPERIMENTAL

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

Behavioral: Group Written Exposure Therapy

Interventions

Group Written Exposure Therapy BEHAVIORAL

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.

Group Written Exposure Therapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Between the ages of 18 and older
• Diagnosis of PTSD
• Able to provide written informed consent and can read and write in English

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Joseph's Healthcare Hamilton: lead

Study Sites (1)

Anxiety Treatment and Research Clinic, St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L8R2Y2, Canada

RECRUITING

Related Publications (8)

• 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.

  PMID: 35015065 BACKGROUND

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

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 20488277 BACKGROUND

• 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.

  BACKGROUND

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Jenna Boyd, Ph.D.

  St. Joseph's Healthcare Hamilton

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jenna Boyd, Ph.D.

CONTACT

905-522-1155; boydj@stjosham.on.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Jenna Boyd

Study Record Dates

• First Submitted: January 27, 2023
• First Posted: February 15, 2023
• Study Start: May 9, 2023
• Primary Completion: May 9, 2025
• Study Completion: May 9, 2025
• Last Updated: April 17, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)