Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
Participants will:
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group Written Exposure Therapy | Experimental | Patients will be invited to participate in group Written Exposure Therapy (described in the "Interventions" section). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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. |
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jenna Boyd, Ph.D. | Contact | 905-522-1155 | 32749 | boydj@stjosham.on.ca |
| Name | Affiliation | Role |
|---|---|---|
| Jenna Boyd, Ph.D. | St. Joseph's Healthcare Hamilton | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anxiety Treatment and Research Clinic, St. Joseph's Healthcare Hamilton | Recruiting | Hamilton | Ontario | L8R2Y2 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35015065 | Background | 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. | |
| 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. | ||
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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. |
| 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. |
| 20488277 | 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. |
| 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. |