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?
調査の概要
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Ontario
-
Hamilton、Ontario、カナダ
- St. Joseph's Healthcare Hamilton
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:なし
- 介入モデル:単一グループの割り当て
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的:Group Extended Written Exposure Therapy
Participants will be invited to participate in group extended Written Exposure Therapy (described in the Interventions section).
|
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.
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
|
PTSD Checklist for DSM-5 (PCL-5)
時間枠: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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Posttraumatic Cognitions Inventory
時間枠: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.
|
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)
時間枠: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.
|
From pre-treatment (1 week before the start of group) to one-month follow-up at about 4 months
|
|
Borderline Symptom List Behaviour Supplement
時間枠:From pre-treatment (1 week before the start of group) to one-month follow-up at about 4 months
|
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.
|
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)
時間枠:From pre-treatment (1 week before the start of group) to one-month follow-up at about 4 months
|
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.
|
From pre-treatment (1 week before the start of group) to one-month follow-up at about 4 months
|
|
Experience of Shame Scale (ESS)
時間枠:From pre-treatment (1 week before the start of group) to one-month follow-up at about 4 months
|
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.
|
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)
時間枠:From pre-treatment (1 week before the start of group) to one-month follow-up at about 4 months
|
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.
|
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)
時間枠:Mid treatment (at about 5 weeks after start of group) and post treatment (at about 10 weeks)
|
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.
|
Mid treatment (at about 5 weeks after start of group) and post treatment (at about 10 weeks)
|
協力者と研究者
出版物と役立つリンク
一般刊行物
- 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.
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- 18906
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。