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临床试验/NCT01094223
NCT01094223已完成不适用

Mindfulness Based Relapse Prevention for Stimulant Users

University of California, Los Angeles1 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2010年4月1日最近更新:
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
62
试验地点
1
主要终点
Depressive symptoms

研究概览

简要总结

The broad, long-term objective of the current research is to improve treatment for stimulant use disorders by augmenting traditional relapse prevention therapy with innovative meditation-based strategies to promote affect regulation skills. Based on Mindfulness-Based Cognitive Therapy for depression (Segal, Teasdale, & Williams, 2002), Marlatt and colleagues recently developed a manualized intervention for the treatment of substance using populations: Mindfulness Based Relapse Prevention (MBRP). The specific aims of this research are 1) To conduct a pilot randomized clinical trial to assess the feasibility of recruiting and retaining individuals for a large scale study and to determine the effect size of MBRP relative to a health education (ED) control group in stimulant users receiving contingency management (CM).

详细描述

Both MBRP and ED participants will be assessed at baseline, treatment-end, and 1 month post-treatment. 2) To test the impact of MBRP compared to ED on negative affect, stimulant use, and health care outcomes. 3) To evaluate the differential effects of MBRP versus ED on HIV-risk behavior of participants, and 4) To examine potential mechanisms of action of MBRP, including reductions in stress reactivity and biological indicators of arousal such as blood pressure and heart rate. The investigators hypothesize that MBRP will be more efficacious than ED in reducing negative affect and stimulant use. Further, the investigators expect that MBRP will produce greater reductions in HIV-risk behaviors, stress reactivity, and arousal, and these changes will be associated with substance use outcomes. MBRP incorporates specific substance-focused cognitive therapy techniques with an additional emphasis on mindfulness skills. By providing coping skills to address affect regulation and stress reactivity, two important factors in stimulant relapse, MBRP may provide a promising augmenting strategy for the treatment of stimulant users.

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
None

入排标准

年龄范围
18 Years 至 59 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Age 18 to 59
  • •DSM-IV diagnosis of Stimulant Dependence
  • •Able to provide informed consent
  • •Willing and able to participate in study procedures

排除标准

  • •Presence of life threatening or unstable medical illness, such as acute pulmonary, cardiovascular, or musculoskeletal disease, that would require treatment or make study participation difficult
  • •Lack of proficiency in English
  • •Currently homeless (unless residing in a recovery home for which contact information can be provided)
  • •Dependence on an illicit substance for which medical detoxification is imminently needed.
  • •Presence of clinically significant psychiatric symptoms as assessed by MINI, such as psychosis or acute mania, that would require ongoing treatment or make study compliance difficult.

研究组 & 干预措施

Mindfulness

Experimental

Mindfulness Based Relapse Prevention (MBRP). Meditation based therapy group incorporating relapse prevention skills training.

干预措施: Mindfulness Based Relapse Prevention (Behavioral)

Health Education

Active Comparator

Health education, psychoeducation group focused on various topics pertaining to physical health

干预措施: Health Education (Behavioral)

结局指标

主要结局

Depressive symptoms

时间窗: baseline (week 0), weekly during treatment (weeks 1-12), and at follow-up (week 24)

The Beck Depression Inventory (BDI), a well validated self-report measure (Beck, 1967) will be administered at baseline, weekly during treatment, and at follow-up. Both the absolute total scores and change scores will be used for analyses.

次要结局

  • HIV Risk behaviors(baseline (week 0), treatment-end (week 12), and follow up (week 24))

研究者

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

Suzette Glasner-Edwards

Principal Investigator

University of California, Los Angeles

研究点 (1)

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