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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01104805
Recruitment Status : Completed
First Posted : April 15, 2010
Last Update Posted : July 11, 2017
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Substance Abuse Behavioral: Therapeutic Education System (TES) Behavioral: Treatment-as-Usual (TAU) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 507 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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)
Study Start Date : April 2010
Actual Primary Completion Date : June 2012
Actual Study Completion Date : September 2012

Arm Intervention/treatment
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.
Other Names:
  • Therapeutic Education System
  • TES

Treatment-as-Usual (TAU)
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.
Other Names:
  • Treatment as Usual
  • TAU
  • Standard Treatment

Primary Outcome Measures :
  1. 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:

    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 :
  1. 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).

  2. 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.

  3. 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.

  4. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01104805

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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
Hina Mauka
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
Project Outreach
West Hempstead, New York, United States, 11552
United States, Oregon
Willamette Family, Inc.
Eugene, Oregon, United States, 97402
United States, Texas
Homeward Bound
Dallas, Texas, United States, 75208
United States, Washington
Evergreen Manor
Everett, Washington, United States, 98201
Sponsors and Collaborators
New York State Psychiatric Institute
National Institute on Drug Abuse (NIDA)
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Principal Investigator: Edward V Nunes, MD NIDA Clinical Trials Network - Long Island Regional Node
Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: New York State Psychiatric Institute Identifier: NCT01104805    
Other Study ID Numbers: NYSPI #6051
U10DA013035 ( U.S. NIH Grant/Contract )
NIDA-CTN-0044 ( Other Identifier: NIDA CTN Protocol Number )
First Posted: April 15, 2010    Key Record Dates
Last Update Posted: July 11, 2017
Last Verified: July 2017
Keywords provided by New York State Psychiatric Institute:
Drug Abuse
Substance Abuse
Substance Use Disorder
Behavioral Treatment
Additional relevant MeSH terms:
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Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders