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Not yet recruiting NCT07576387

Extended Group Written Exposure Therapy for Comorbid PTSD and BPD (Traits)

No phase Interventional Posttraumatic Stress Disorder (PTSD) Borderline Personality Disorder (BPD)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Group Written Exposure Therapy.
Who it may be relevant to
Registry conditions: Posttraumatic Stress Disorder (PTSD), Borderline Personality Disorder (BPD). Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

The goal of this open label trial is to evaluate the effectiveness of virtual group extended Written Exposure Therapy (GE-WET) in reducing Post-Traumatic Stress Disorder (PTSD) symptoms in patients with comorbid PTSD and Borderline Personality Disorder (BPD) or BPD traits. GE-WET involves attending weekly 2-hour group WET sessions for the duration of 10 weeks, in which they write about their trauma experience using specific instructions. This study will be conducted at St. Joseph's Healthcare Hamilton's Community Psychiatry Clinic with clients wait listed for PTSD treatment (ages 18- 65, any gender, co-morbid PTSD and BPD/BPD traits). The main questions this study aims to answer are: Does GE-WET reduce PTSD symptoms (based on PCL-5 measures) in this population (outpatient clients ages 18-65 of any gender, with a diagnosis of PTSD and BPD or BPD traits)? Does GE-WET result in reduced drop-out rates for this population, compared to that of other evidence-based treatment for PTSD? What are participants subjective experience of GE-WET?

Interventions

  • Behavioral Group Written Exposure Therapy
    Group Extended Written Exposure Therapy (GE-WET) is a time-limited cognitive behavioural therapy for Posttraumatic Stress Disorder (PTSD) aimed at allowing patients to process their traumatic experiences in a safe environment. GE-WET will consist of 10 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

Primary outcome measures

  • PTSD Checklist for DSM-5 (PCL-5) [Time frame: From pre-treatment (1 week before the start of group) to one-month follow-up at about 4 months]
Secondary outcome measures (7)
  • Posttraumatic Cognitions Inventory [Time frame: From pre-treatment (1 week before the start of group) to one-month follow-up at about 4 months]
  • Borderline Symptom List- Short Version (BSL-23) [Time frame: From pre-treatment (1 week before the start of group) to one-month follow-up at about 4 months]
  • Borderline Symptom List Behaviour Supplement [Time frame: From pre-treatment (1 week before the start of group) to one-month follow-up at about 4 months]
  • Toronto Alexithymia Scale-20 (TAS-20) [Time frame: From pre-treatment (1 week before the start of group) to one-month follow-up at about 4 months]
  • Experience of Shame Scale (ESS) [Time frame: From pre-treatment (1 week before the start of group) to one-month follow-up at about 4 months]
  • Difficulties in Emotion Regulation Scale (DERS) [Time frame: From pre-treatment (1 week before the start of group) to one-month follow-up at about 4 months]
  • Group Cohesion Scale - Revised (GCS-R) [Time frame: Mid treatment (at about 5 weeks after start of group) and post treatment (at about 10 weeks)]

Eligibility criteria

Inclusion criteria

  • Reading and writing proficiency in English
  • Access to an electronic device to attend virtual group meetings
  • Age 18-65
  • Previous diagnosis of Posttraumatic Stress Disorder (PTSD) and Borderline Personality Disorder (BPD)/BPD traits
  • Completion of a DBT skills group via St. Joe's Community Psychiatry Clinic

Exclusion criteria

  • Diagnosis of an active severe substance use disorder or psychotic disorder
  • Untreated active psychotic symptoms, mania, or hypomania
  • Has attempted suicide in the 2 months prior to treatment beginning
  • Has engaged in high-risk self-harm (e.g., cutting, burning, asphyxiation) in the 2 months prior to beginning treatment
  • Has completed Cognitive Processing Therapy or another active PTSD treatment (i.e., prolonged exposure) in the past year

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Canada · 1 center
  • St. Joseph's Healthcare Hamilton — Hamilton

Publications

  • 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.
  • 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.
  • Andrews B, Qian M, Valentine JD. Predicting depressive symptoms with a new measure of shame: The Experience of Shame Scale. Br J Clin Psychol. 2002 Mar;41(Pt 1):29-42. doi: 10.1348/014466502163778. PMID 11931676
  • Bagby RM, Taylor GJ, Parker JD. The Twenty-item Toronto Alexithymia Scale--II. Convergent, discriminant, and concurrent validity. J Psychosom Res. 1994 Jan;38(1):33-40. doi: 10.1016/0022-3999(94)90006-x. PMID 8126688
  • Bohus M, Kleindienst N, Limberger MF, Stieglitz RD, Domsalla M, Chapman AL, Steil R, Philipsen A, Wolf M. The short version of the Borderline Symptom List (BSL-23): development and initial data on psychometric properties. Psychopathology. 2009;42(1):32-9. doi: 10.1159/000173701. Epub 2008 Nov 20. PMID 19023232
  • 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.

Identifiers

NCT: NCT07576387 · 18906

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗