Web-delivery of Evidence-based, Psychosocial Treatment for Substance Use Disorders

Substance Abuse Clinical Trial

— CTN-0044  

Official title:

NIDA-CTN-0044: Web-delivery of Evidence-Based, Psychosocial Treatment for Substance Use Disorders Using the Therapeutic Education System (TES)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01104805
• Other study ID #: NYSPI #6051
• Secondary ID: U10DA013035NIDA-
• Status: Completed
• Phase: N/A
• First received: April 14, 2010
• Last updated: July 6, 2017
• Start date: April 2010
• Est. completion date: September 2012

Study information

• Verified date: July 2017
• Source: New York State Psychiatric Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 507
• Est. completion date: September 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Substance Abuse
• Substance-Related Disorders

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	HARBEL Prevention and Recovery Center	Baltimore	Maryland
United States	Homeward Bound	Dallas	Texas
United States	MCCA: Midwestern CT Council on Alcoholism	Danbury	Connecticut
United States	Willamette Family, Inc.	Eugene	Oregon
United States	Evergreen Manor	Everett	Washington
United States	Stanley Street Treatment and Resources (SSTAR)	Fall River	Massachusetts
United States	Midtown Community Mental Health Center	Indianapolis	Indiana
United States	The Center for Drug Free Living	Orlando	Florida
United States	Hina Mauka	Waipahu	Hawaii
United States	Project Outreach	West Hempstead	New York

Sponsors (2)

Lead Sponsor	Collaborator
New York State Psychiatric Institute	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduced Substance Use and Improved Treatment Retention	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.	12-week Treatment Phase
Secondary	Effectiveness	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).	12-week treatment phase, 3- and 6-months post treatment
Secondary	Sustained outcome	To evaluate if improved substance use and retention outcomes are maintained 3- and 6-months post-intervention.	3- and 6-months post treatment
Secondary	Economic Analysis	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.	12-week treatment phase, 3- and 6-months post treatment
Secondary	Coping Skills	To examine coping skills acquisition as a treatment process factor that may underlie changes observed during treatment.	12-week treatment phase, 3- and 6-months post treatment

External Links

•   National Institute on Drug Abuse, Clinical Trials Network