Web-delivery of Evidence-based, Psychosocial Treatment for Substance Use Disorders
- Conditions
- Substance Abuse
- Interventions
- Behavioral: Treatment-as-Usual (TAU)Behavioral: Therapeutic Education System (TES)
- Registration Number
- NCT01104805
- Lead Sponsor
- New York State Psychiatric Institute
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 507
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treatment-as-Usual (TAU) Treatment-as-Usual (TAU) Participants randomized to TAU will receive standard treatment offered and prescribed, as usual, in the outpatient substance abuse treatment program. Therapeutic Education System (TES) Therapeutic Education System (TES) Participants randomized to this arm will replace approximately 2 hours of Standard Treatment with the Therapeutic Education System (TES) (comprised of a web-based version of the Community Reinforcement Approach and contingency management).
- Primary Outcome Measures
Name Time Method Reduced Substance Use and Improved Treatment Retention 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.
- Secondary Outcome Measures
Name Time Method Sustained outcome 3- and 6-months post treatment To evaluate if improved substance use and retention outcomes are maintained 3- and 6-months post-intervention.
Economic Analysis 12-week treatment phase, 3- and 6-months post treatment To perform a comprehensive economic analysis of including TES in TAU to inform decisions regarding adoption of this new therapeutic tool (assessing incremental costs per increased abstinence time and quality adjusted life year). The economic analyses are clinically important, as even if the computerized intervention is shown to be effective, it may not be adopted in community-based treatment programs unless it is shown to be cost-effective due to the considerable financial constraints in such treatment settings.
Effectiveness 12-week treatment phase, 3- and 6-months post treatment To evaluate the relative effectiveness of TAU vs. modified TAU + TES on several secondary outcome measures, including measures of HIV risk behavior, psychosocial functioning (in areas of criminal activity, health status improvement, psychological status, family/social relationships, and employment, and treatment acceptability (based on participant feedback).
Coping Skills 12-week treatment phase, 3- and 6-months post treatment To examine coping skills acquisition as a treatment process factor that may underlie changes observed during treatment.
Trial Locations
- Locations (10)
Project Outreach
🇺🇸West Hempstead, New York, United States
Willamette Family, Inc.
🇺🇸Eugene, Oregon, United States
Hina Mauka
🇺🇸Waipahu, Hawaii, United States
The Center for Drug Free Living
🇺🇸Orlando, Florida, United States
Midtown Community Mental Health Center
🇺🇸Indianapolis, Indiana, United States
HARBEL Prevention and Recovery Center
🇺🇸Baltimore, Maryland, United States
Homeward Bound
🇺🇸Dallas, Texas, United States
Stanley Street Treatment and Resources (SSTAR)
🇺🇸Fall River, Massachusetts, United States
MCCA: Midwestern CT Council on Alcoholism
🇺🇸Danbury, Connecticut, United States
Evergreen Manor
🇺🇸Everett, Washington, United States