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临床试验/NCT03678051
NCT03678051已完成不适用

A Randomized Trial of CBT4CBT for Women in Residential Treatment for Substance Use Disorders

Virginia Commonwealth University2 个研究点 分布在 1 个国家目标入组 63 人开始时间: 2018年10月4日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
63
试验地点
2
主要终点
Days of Use

研究概览

简要总结

This project examines computer-delivered cognitive-behavioral intervention (CBT4CBT) as an adjunct to residential treatment for women with substance use disorders (SUD). The project will conduct a 2-arm randomized clinical trial (RCT) comparing post-discharge relapse rates for treatment as usual (TAU) with access to the CBT4CBT program vs. TAU in a residential sample of women with SUDs.

详细描述

Women with substance use disorders face unique barriers to substance use treatment, and as a result, are less likely to seek treatment for substance use than their male counterparts. Women's residential treatment settings have been shown to have higher rates of treatment completion and better outcomes; however, relapse rates for substance use are high, with estimates ranging from 40-60%. Cognitive behavioral therapy (CBT) has been identified as an evidence-based treatment known to improve relapse rates by teaching clients how to recognize and respond to their cues for substance use. Women may particularly benefit from CBT, as their relapse risk factors include depression, interpersonal stress, and relationship conflict.

Despite the effectiveness of CBT, its dissemination is hindered due to limited availability of trained clinicians, cost, and limited resources. Computer-based training for cognitive behavioral therapy (CBT4CBT) offers an opportunity to improve the quality and reach of treatment services that is both feasible and cost-effective. Studies to date have demonstrated the utility of CBT4CBT in outpatient settings; however, it has not yet been evaluated as an adjunct to residential treatment for SUDs.

The specific aims are to: 1) Examine feasibility for use of CBT4CBT in a residential treatment program for women with SUDs; 2) Conduct a small RCT comparing TAU with access to the CBT4CBT program (CBT4CBT; intervention) vs. treatment as usual (TAU; control) using relapse rates and days of use as primary treatment outcomes; 3) Exploratory analyses will identify other correlates (e.g., coping strategies, depression) of relapse at 4 and 12 weeks post-discharge.

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 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • ≥18 years of age
  • Meet DSM-5 criteria for a SUD (current)
  • Own a smartphone
  • Can return to facility for the 4 and 12-week follow-up visits.

排除标准

  • Cognitive or psychiatric impairment
  • Language barriers that preclude informed consent

结局指标

主要结局

Days of Use

时间窗: 12-week follow-up period

Number of days of any substance use in 12 weeks post-discharge.

Any Relapse

时间窗: 12-week follow-up period

Percent of participants experiencing any relapse (yes/no), defined as any substance use (alcohol or other drugs) by self-report (smartphone or in person) and/or urine drug toxicology or Breathalyzer during 12-week follow-up period.

次要结局

  • Time to Relapse:(12-week follow-up period)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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