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临床试验/NCT00117741
NCT00117741已完成不适用

Evaluation of Dialectical Behavior Therapy (DBT)

University of Washington2 个研究点 分布在 1 个国家目标入组 86 人开始时间: 2004年6月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
86
试验地点
2
主要终点
Urinalysis

研究概览

简要总结

The purpose of this study is to compare a one year treatment program of Dialectical Behavior Therapy (DBT) + suboxone for opiate addicted individuals meeting criteria for borderline personality disorder (BPD) to a one year program of standard drug counseling (I/GDC) + suboxone.

详细描述

The purpose of this study is to compare a one year treatment program of Dialectical Behavior Therapy (DBT) + suboxone for opiate addicted individuals meeting criteria for borderline personality disorder (BPD) to a one year program of standard drug counseling (I/GDC) + suboxone. Drug counseling consists of manualized individual sessions + group therapy. This trial is being completed at two sites, at the University of Washington and at Duke University. One hundred and seventy-two individuals (86 per condition) with opiate dependence and meeting criteria for BPD will be enrolled in a one-year treatment and a one-year follow-up assessment. Each site (University of Washington, Duke) will enroll 86 clients with both treatment conditions being conducted at each site. Assessments measuring drug use, suicidal behaviors, retention and other treatment-related behaviors, general psychopathology and functioning, and increases in behavioral skills will be given at four month intervals for the entire two years.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Meets SCID-I criteria for opiate dependence.
  • Meets IPDE and SCID criteria for BPD (DSM-IV)
  • Over 18 years old
  • Resides within commuting distance of treatment
  • Consents to outpatient treatment for drug addiction

排除标准

  • Bipolar, Schizophrenia, Schizophreniform, or Schizoaffective Disorders, Psychosis NOS
  • IQ less than 70; life threatening anorexia; current and chronic absence of shelter; impending jail/prison for more than three weeks (problems which by their presence or severity preclude ability to attend or understand treatment and/or requires priority treatment over SUD treatment)
  • Court order to treatment, court order to treatment or to jail, or agency order to treatment or loss of child custody (due to consequent inability to freely drop-out of treatment)
  • Is pregnant, plans to become pregnant during treatment phase, or becomes pregnant before random assignment to study condition
  • Is unable to tolerate suboxone induction phase
  • Is currently stable on methadone
  • Current benzodiazepine use from which the participant is unwilling to taper
  • Refuses: to discontinue current mental health or drug abuse treatment or random assignment.

研究组 & 干预措施

Dialectical Behavior Therapy

Experimental

Participants receive standard dialectical behavior therapy and suboxone

干预措施: Dialectical Behavior Therapy (Behavioral)

Drug Counseling

Active Comparator

Participants receive standard individual and group counseling and suboxone.

干预措施: Drug Counseling (Behavioral)

结局指标

主要结局

Urinalysis

时间窗: one year treatment, one year follow-up

次要结局

  • Suicidal Behavior(one year treatment, one year follow-up)
  • Depression, anxiety, Axis I diagnostic remission(one year treatment, one year follow-up)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Marsha Linehan

Professor

University of Washington

研究点 (2)

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