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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT01104805
First received: April 14, 2010
Last updated: October 15, 2012
Last verified: October 2012
  Purpose

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 Intervention Phase
Substance Abuse
Behavioral: Therapeutic Education System (TES)
Behavioral: Treatment-as-Usual (TAU)
Phase 3

Study Type: Interventional
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)

Further study details as provided by New York State Psychiatric Institute:

Primary Outcome Measures:
  • Reduced Substance Use and Improved Treatment Retention [ Time Frame: 12-week Treatment Phase ] [ Designated as safety issue: No ]

    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:
  • Effectiveness [ Time Frame: 12-week treatment phase, 3- and 6-months post treatment ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    To examine coping skills acquisition as a treatment process factor that may underlie changes observed during treatment.


Enrollment: 507
Study Start Date: April 2010
Study Completion Date: September 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01104805

Locations
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
Investigators
Principal Investigator: Edward V Nunes, MD NIDA Clinical Trials Network - Long Island Regional Node
  More Information

Additional Information:
No publications provided by New York State Psychiatric Institute

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT01104805     History of Changes
Other Study ID Numbers: NYSPI #6051, U10DA013035, NIDA-CTN-0044
Study First Received: April 14, 2010
Last Updated: October 15, 2012
Health Authority: United States: National Institute on Drug Abuse (NIDA)
United States: Federal Government

Keywords provided by New York State Psychiatric Institute:
Drug Abuse
Substance Abuse
Substance Use Disorder
Addiction
Behavioral Treatment

Additional relevant MeSH terms:
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 28, 2014