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临床试验/NCT01193205
NCT01193205
已完成
1 期

Evaluating the Effectiveness of Dialectical Behaviour Skills Training for Suicidality in Borderline Personality Disorder

Centre for Addiction and Mental Health1 个研究点 分布在 1 个国家目标入组 84 人2010年7月

概览

阶段
1 期
干预措施
未指定
疾病 / 适应症
Borderline Personality Disorder
发起方
Centre for Addiction and Mental Health
入组人数
84
试验地点
1
主要终点
Deliberate Self-harm Inventory (DSHI; Gratz, 2001) and Lifetime Suicide Attempt Self-Injury interview (LSASI; formerly Lifetime Parasuicide Count, Linehan MM, Comtois KA, unpublished manuscript, 1996)
状态
已完成
最后更新
9年前

概览

简要总结

The aim of this study is to evaluate the effectiveness of a 20-week Dialectical Behaviour Therapy (DBT) skills training group for the treatment of chronic suicidal and non-suicidal self-injurious (NSSI) behaviours in individuals diagnosed with borderline personality disorder (BPD). Previous research has established the effectiveness of a one year comprehensive, combined individual and group DBT treatment. However, in practice, DBT is often offered in a skills only group format. This study will consist of a randomized, controlled trial designed to evaluate the effectiveness of DBT compared to a wait list control. 84 participants will be randomized to the 20-week DBT group or the wait-list and the following outcomes will be assessed:

  1. frequency of suicidal and NSSI behaviours
  2. symptom distress
  3. impulsivity
  4. treatment retention
  5. skill acquisition and
  6. social functioning

Assessments will occur at pre-treatment, 10 weeks, 20 weeks and 3 months post treatment. The following main hypotheses will be examined: (1) Patients in the DBT skills group condition will have superior outcomes to patients on the treatment as usual wait list control in areas targeted by the treatment: frequency of suicidal and NSSI behaviours, emergency room visits, psychiatric hospital admissions, impulsivity, and knowledge and use of behavioral skills, general symptoms. The group receiving DBT will have superior outcomes at post treatment and these outcomes will be maintained during the three month post-treatment follow-up.

详细描述

The study will consist of a single-blind, two-arm randomized controlled trial designed to evaluate the effectiveness of DBT skills group offered as an adjunct to treatment as usual compared to a wait list control plus treatment as usual. The continuation of treatment as usual in both arms is permitted for two reasons. First, it would be unethical to assign suicidal patients to a wait list condition that prohibited involvement in ongoing treatment. Second, the proposed design enables us to address the question of the additive effect of the DBT skills group intervention. Subjects will be randomized to receive 20 weeks of DBT group skills training plus treatment as usual, or to a wait list control plus treatment as usual. Clinical effectiveness outcomes will be assessed at baseline, at 10 weeks, at 20 weeks and at 8 months follow-up. DBT skills training is a manualized intervention developed by Linehan (1993). Key skills from the modules described in Miller, Rathus, and Linehan (2006) will serve as the basis of the DBT skills group, delivered in a psychoeducational format over the course of weekly two-hour sessions. The skills group covers five modules: mindfulness, emotion regulation, distress tolerance, interpersonal effectiveness, and dialectics.

注册库
clinicaltrials.gov
开始日期
2010年7月
结束日期
2012年12月
最后更新
9年前
研究类型
Interventional
研究设计
Single Group
性别
All

研究者

责任方
Principal Investigator
主要研究者

Shelley McMain

Head, Borderline Personality Disorder Clinic

Centre for Addiction and Mental Health

入排标准

入选标准

  • diagnosis of DSM-IV Borderline Personality Disorder
  • 18-60 years of age
  • have had two suicidal or non-suicidal self-injurious behaviours in the past five years with one occurring in the past ten weeks
  • be literate in English
  • provide informed consent to participate in the study.

排除标准

  • not meet DSM-IV criteria for a psychotic disorder, bipolar disorder or, dementia
  • not have evidence of an organic brain syndrome or mental retardation based on clinical interview
  • not participated in DBT treatment during the past year

结局指标

主要结局

Deliberate Self-harm Inventory (DSHI; Gratz, 2001) and Lifetime Suicide Attempt Self-Injury interview (LSASI; formerly Lifetime Parasuicide Count, Linehan MM, Comtois KA, unpublished manuscript, 1996)

时间窗: baseline; 10 weeks; 20 weeks; 3 month follow up

Self-report measures assessing self-harm and suicidal behaviour

次要结局

  • Barett Impulsiveness Scale (BIS-11; Patton et al., 1995)(Baseline; 10 weeks; 20 weeks; 3 months follow up)
  • The State-trait Anger Expression Inventory (STAXI; Spielberger, Krasner & Solomon, 1988)(Baseline; 10 weeks; 20 weeks; 3 months Follow up)
  • The Borderline Evaluation of Severity over time Scale (BEST; Phfolm & Bloom, 1997)(Baseline; 10 weeks; 20 weeks; 3 months Follow up)
  • Treatment History Interview (THI-2; Linehan & Heard, 1987)(baseline; 10 weeks; 20 weeks; 3 month follow up)
  • The Symptom Checklist 90 - Revised (SCL-90-R; Derogatis, 1983)(Baseline; 10 weeks; 20 weeks; 3 months Follow up)

研究点 (1)

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