NIDA-CTN-0044: Web-delivery of Evidence-Based, Psychosocial Treatment for Substance Use Disorders Using the Therapeutic Education System (TES)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 507
- 试验地点
- 20
- 主要终点
- Reduced Substance Use and Improved Treatment Retention
研究概览
简要总结
The main objective of this study is to evaluate the effectiveness of including an interactive, web-based version of the Community Reinforcement Approach (CRA), called the Therapeutic Education System (TES), as part of community-based, outpatient substance abuse treatment.
详细描述
The principal objective of the planned trial is to evaluate the effectiveness of including an interactive, web-based version of the Community Reinforcement Approach (CRA), called the Therapeutic Education System (TES), as part of community-based, outpatient substance abuse treatment. CRA is a cognitive-behavioral intervention which seeks to give patients skills to achieve and maintain abstinence and improve social functioning and is often paired with contingency management, where patients earn rewards contingent upon drug negative urines. CRA is an intensive treatment, generally delivered in individual sessions 2 to 3 times per week. Thus, it is expensive and time-consuming to deliver, to train clinical staff, and to provide supervision to maintain clinical staff skill. However, because CRA is oriented toward knowledge and skills, it lends itself to being delivered by computer, using computer-interactive learning technologies.
Individuals accepted into community-based outpatient treatment for substance use disorders (excluding those receiving opioid pharmacotherapy for opioid dependence) will be eligible to participate. This is a multi-site, controlled trial, using NIDA's Clinical Trials Network platform, at approximately 10 Community Treatment Programs, in which participants (N = approximately 500) will be randomized to receive 12 weeks of either: (1) Treatment-as-Usual (TAU), reflecting standard treatment at the collaborating treatment programs in which participants are enrolled, or (2) a modification of TAU which includes access to the TES. It is hypothesized that access to TES will improve substance use outcome and retention in outpatient treatment.
Computer interactive interventions like TES have the potential to deliver science-based psychosocial treatments with high fidelity and cost-effectiveness while conserving clinician time to focus on monitoring and addressing patients' needs. If found to be effective, TES could substantially advance the substance abuse treatment system by improving quality of care delivered, increasing availability of treatment slots by extending and leveraging the efforts of clinical staff, and projecting treatment to rural and other underserved areas.
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 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female patients, 18 years or older, accepted for outpatient, substance abuse treatment at a participating study site.
- •Self-report any substance use problem (including alcohol, as long as they also report other drug use in addition to alcohol).
- •Self-report recent drug use.
- •Within 30 days of initiating treatment at a collaborating study site.
- •Self-report a planned substance abuse treatment episode of at least 3 months.
排除标准
- •Receiving opioid replacement medication.
- •Plan to move out of the area within the next 3 months.
- •Insufficient ability to provide informed consent.
- •Insufficient ability to use English to participate meaningfully in the consent process, the interventions or research assessments.
结局指标
主要结局
Reduced Substance Use and Improved Treatment Retention
时间窗: 12-week Treatment Phase
Compared to patients assigned to Treatment as Usual (TAU), patients assigned to modified TAU plus the Therapeutic Education System (Modified TAU + TES) will have: 1. reduced substance use (measured by a combination of self-report confirmed by urine toxicology) and 2. better retention in treatment at their community-based treatment programs.
次要结局
- Sustained outcome(3- and 6-months post treatment)
- Economic Analysis(12-week treatment phase, 3- and 6-months post treatment)
- Effectiveness(12-week treatment phase, 3- and 6-months post treatment)
- Coping Skills(12-week treatment phase, 3- and 6-months post treatment)
