- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07576387
Extended Group Written Exposure Therapy for Comorbid PTSD and BPD (Traits)
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?
Přehled studie
Postavení
Intervence / Léčba
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Ontario
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Hamilton, Ontario, Kanada
- St. Joseph's Healthcare Hamilton
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: Group Extended Written Exposure Therapy
Participants will be invited to participate in group extended Written Exposure Therapy (described in the Interventions section).
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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 exposure.
There is no homework assigned between sessions.
However, group members will be asked to refrain from avoiding thinking about the trauma between sessions.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Časové okno |
|---|---|
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PTSD Checklist for DSM-5 (PCL-5)
Časové okno: From pre-treatment (1 week before the start of group) to one-month follow-up at about 4 months
|
From pre-treatment (1 week before the start of group) to one-month follow-up at about 4 months
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Posttraumatic Cognitions Inventory
Časové okno: From pre-treatment (1 week before the start of group) to one-month follow-up at about 4 months
|
A 36-item self-report questionnaire that assesses negative thoughts across three subscales: negative cognitions about the self (e.g., "I am a weak person"), negative cognitions about the world (e.g., "I have to be on guard all the time"), and self-blame (e.g., "the event happened because of the way I acted").
The PTCI has demonstrated good internal consistency, test-retest reliability, and convergent validity with other measures of posttraumatic cognitions.
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From pre-treatment (1 week before the start of group) to one-month follow-up at about 4 months
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Borderline Symptom List- Short Version (BSL-23)
Časové okno: From pre-treatment (1 week before the start of group) to one-month follow-up at about 4 months
|
The BSL-23 is a 23-item self-report measure that assesses for DSM borderline personality disorder symptomatology as well as associated problems such as self-criticism, loneliness, helplessness, and problems with trust.
The BSL-23 has demonstrated high internal consistency and test-retest reliability, and strong convergent validity with correlations with depression and general psychopathology severity.
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From pre-treatment (1 week before the start of group) to one-month follow-up at about 4 months
|
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Borderline Symptom List Behaviour Supplement
Časové okno: From pre-treatment (1 week before the start of group) to one-month follow-up at about 4 months
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The BSL-23 Behaviour Supplement is an 11-item supplemental measure used to assess frequency of problematic behaviours (e.g., non-suicidal self-injury, suicide attempts, suicidal communication, angry outbursts, misuse of substances, etc.) associated with borderline personality disorder.
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From pre-treatment (1 week before the start of group) to one-month follow-up at about 4 months
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Toronto Alexithymia Scale-20 (TAS-20)
Časové okno: From pre-treatment (1 week before the start of group) to one-month follow-up at about 4 months
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The TAS-20 is a 20-item self-report measure assessing for alexithymia (i.e., issues in identifying and processing emotions) across three factors: difficulty identifying feelings, difficulty describing feelings, and externally-oriented thinking.
The TAS-20 has demonstrated adequate levels of convergent validity, good internal consistency, and good test-retest reliability.
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From pre-treatment (1 week before the start of group) to one-month follow-up at about 4 months
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Experience of Shame Scale (ESS)
Časové okno: From pre-treatment (1 week before the start of group) to one-month follow-up at about 4 months
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The ESS is a 25-item self-report measure assessing characterological shame (e.g., shame of personal habits or personal ability), behavioural shame (e.g., shame in doing or saying something wrong), and bodily shame (e.g., shame regarding one's body).
The ESS has demonstrated good internal consistency and test-retest reliability.
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From pre-treatment (1 week before the start of group) to one-month follow-up at about 4 months
|
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Difficulties in Emotion Regulation Scale (DERS)
Časové okno: From pre-treatment (1 week before the start of group) to one-month follow-up at about 4 months
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The DERS is a widely used 36-item self-report measure assessing six dimensions of emotion regulation difficulties.
The DERS demonstrates good internal consistency, convergent validity, and predictive validity of behaviours reflective of emotion regulation difficulties.
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From pre-treatment (1 week before the start of group) to one-month follow-up at about 4 months
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Group Cohesion Scale - Revised (GCS-R)
Časové okno: Mid treatment (at about 5 weeks after start of group) and post treatment (at about 10 weeks)
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The GCS-R is a self-report measure that measure's group member's perception of their group and the strength of the bonds formed.
The GCS-R showed high reliability for use in research and is sensitive to detecting changes in cohesiveness as a function of group development.
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Mid treatment (at about 5 weeks after start of group) and post treatment (at about 10 weeks)
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Spolupracovníci a vyšetřovatelé
Sponzor
Publikace a užitečné odkazy
Obecné publikace
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
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