Web-delivery of Evidence-based, Psychosocial Treatment for Substance Use Disorders (CTN-0044)

New York State Psychiatric Institute

Status: Completed

Conditions: Substance Abuse

Treatments: Behavioral: Treatment-as-Usual (TAU); Behavioral: Therapeutic Education System (TES)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01104805

NIDA-CTN-0044 (Other Identifier)

U10DA013035 (U.S. NIH Grant/Contract)

NYSPI #6051

Details and patient eligibility

About

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.

Full 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.

Enrollment: 507 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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507 participants in 2 patient groups

Therapeutic Education System (TES)

Experimental group

Description:

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).

Treatment:

Behavioral: Therapeutic Education System (TES)

Treatment-as-Usual (TAU)

Other group

Description:

Participants randomized to TAU will receive standard treatment offered and prescribed, as usual, in the outpatient substance abuse treatment program.

Treatment:

Behavioral: Treatment-as-Usual (TAU)