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

• ClinicalTrials.gov Identifier: NCT01104805
• Recruitment Status: Completed
• First Posted: April 15, 2010
• Last Update Posted: July 11, 2017
• Sponsor: New York State Psychiatric Institute
• Collaborator: National Institute on Drug Abuse (NIDA)
• Information provided by (Responsible Party): New York State Psychiatric Institute

Tracking Information

• First Submitted Date: April 14, 2010
• First Posted Date: April 15, 2010
• Last Update Posted Date: July 11, 2017
• Study Start Date: April 2010
• Actual Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 14, 2010)

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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: April 14, 2010)

• 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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

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

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.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Substance Abuse

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.
  Other Names:

  • Therapeutic Education System
  • TES
• 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

Study Arms

• 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).
  Intervention: Behavioral: 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.
  Intervention: Behavioral: Treatment-as-Usual (TAU)

Publications *

• Luderer HF, Campbell ANC, Nunes EV, Enman NM, Xiong X, Gerwien R, Maricich YA. Engagement patterns with a digital therapeutic for substance use disorders: Correlations with abstinence outcomes. J Subst Abuse Treat. 2022 Jan;132:108585. doi: 10.1016/j.jsat.2021.108585. Epub 2021 Jul 30.
• Murphy SM, Campbell AN, Ghitza UE, Kyle TL, Bailey GL, Nunes EV, Polsky D. Cost-effectiveness of an internet-delivered treatment for substance abuse: Data from a multisite randomized controlled trial. Drug Alcohol Depend. 2016 Apr 1;161:119-26. doi: 10.1016/j.drugalcdep.2016.01.021. Epub 2016 Jan 30.
• Cochran G, Stitzer M, Campbell AN, Hu MC, Vandrey R, Nunes EV. Web-based treatment for substance use disorders: differential effects by primary substance. Addict Behav. 2015 Jun;45:191-4. doi: 10.1016/j.addbeh.2015.02.002. Epub 2015 Feb 8.
• Mitchell SG, Schwartz RP, Alvanzo AA, Weisman MS, Kyle TL, Turrigiano EM, Gibson ML, Perez L, McClure EA, Clingerman S, Froias A, Shandera DR, Walker R, Babcock DL, Bailey GL, Miele GM, Kunkel LE, Norton M, Stitzer ML. The Use of Technology in Participant Tracking and Study Retention: Lessons Learned From a Clinical Trials Network Study. Subst Abus. 2015;36(4):420-6. doi: 10.1080/08897077.2014.992565. Epub 2015 Feb 11.
• Cochran G, Stitzer M, Nunes EV, Hu MC, Campbell A. Clinically relevant characteristics associated with early treatment drug use versus abstinence. Addict Sci Clin Pract. 2014 Apr 4;9(1):6. doi: 10.1186/1940-0640-9-6.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 15, 2012): 507
• Original Estimated Enrollment (submitted: April 14, 2010): 500
• Actual Study Completion Date: September 2012
• Actual Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01104805
• Other Study ID Numbers: NYSPI #6051; U10DA013035 ( U.S. NIH Grant/Contract ); NIDA-CTN-0044 ( Other Identifier: NIDA CTN Protocol Number )
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: New York State Psychiatric Institute
• Original Responsible Party: Edward V. Nunes, M.D., Professor of Clinical Psychiatry, NYSPI/Columbia University
• Current Study Sponsor: New York State Psychiatric Institute
• Original Study Sponsor: National Institute on Drug Abuse (NIDA)
• Collaborators: National Institute on Drug Abuse (NIDA)

Investigators

• Principal Investigator: Edward V Nunes, MD; NIDA Clinical Trials Network - Long Island Regional Node

• PRS Account: New York State Psychiatric Institute
• Verification Date: July 2017