Web-delivery of Evidence-based, Psychosocial Treatment for Substance Use Disorders (CTN-0044)
|Substance Abuse||Behavioral: Therapeutic Education System (TES) Behavioral: Treatment-as-Usual (TAU)||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||NIDA-CTN-0044: Web-delivery of Evidence-Based, Psychosocial Treatment for Substance Use Disorders Using the Therapeutic Education System (TES)|
- Reduced Substance Use and Improved Treatment Retention [ Time Frame: 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:
- reduced substance use (measured by a combination of self-report confirmed by urine toxicology) and
- better retention in treatment at their community-based treatment programs.
- Effectiveness [ Time Frame: 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).
- Sustained outcome [ Time Frame: 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 [ Time Frame: 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.
- Coping Skills [ Time Frame: 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.
|Study Start Date:||April 2010|
|Study Completion Date:||September 2012|
|Primary Completion Date:||June 2012 (Final data collection date for primary outcome measure)|
Experimental: 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).
Behavioral: Therapeutic Education System (TES)
Participants will received modified treatment-as-usual plus the computerized psychosocial intervention (Therapeutic Education System), including contingency management. Participants will be asked to use the self-directed TES intervention twice weekly and will be asked to complete 2 modules during each session (for a total of 4 modules per week) during the 12-week intervention. Participants will receive incentives contingent primarily upon abstinence from drugs of abuse and, secondarily, upon completion of TES modules.
Participants randomized to TAU will receive standard treatment offered and prescribed, as usual, in the outpatient substance abuse treatment program.
Behavioral: Treatment-as-Usual (TAU)
Participants in this condition will receive TAU, consisting of standard treatment offered at each collaborating CTP and will reflect the model of treatment typically provided to most individuals in outpatient, community-based substance abuse treatment settings in the U.S. These sessions will consist of a combination of group and individual counseling.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01104805
|United States, Connecticut|
|MCCA: Midwestern CT Council on Alcoholism|
|Danbury, Connecticut, United States, 06810|
|United States, Florida|
|The Center for Drug Free Living|
|Orlando, Florida, United States, 32856|
|United States, Hawaii|
|Waipahu, Hawaii, United States, 96797|
|United States, Indiana|
|Midtown Community Mental Health Center|
|Indianapolis, Indiana, United States, 46208|
|United States, Maryland|
|HARBEL Prevention and Recovery Center|
|Baltimore, Maryland, United States, 21214|
|United States, Massachusetts|
|Stanley Street Treatment and Resources (SSTAR)|
|Fall River, Massachusetts, United States, 02720|
|United States, New York|
|West Hempstead, New York, United States, 11552|
|United States, Oregon|
|Willamette Family, Inc.|
|Eugene, Oregon, United States, 97402|
|United States, Texas|
|Dallas, Texas, United States, 75208|
|United States, Washington|
|Everett, Washington, United States, 98201|
|Principal Investigator:||Edward V Nunes, MD||NIDA Clinical Trials Network - Long Island Regional Node|