Web-delivery of Evidence-based, Psychosocial Treatment for Substance Use Disorders
CTN-0044
NIDA-CTN-0044: Web-delivery of Evidence-Based, Psychosocial Treatment for Substance Use Disorders Using the Therapeutic Education System (TES)
3 other identifiers
interventional
507
1 country
10
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2010
Typical duration for not_applicable
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2010
CompletedFirst Submitted
Initial submission to the registry
April 14, 2010
CompletedFirst Posted
Study publicly available on registry
April 15, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2012
CompletedJuly 11, 2017
July 1, 2017
2.2 years
April 14, 2010
July 6, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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: 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.
12-week Treatment Phase
Secondary Outcomes (4)
Effectiveness
12-week treatment phase, 3- and 6-months post treatment
Sustained outcome
3- and 6-months post treatment
Economic Analysis
12-week treatment phase, 3- and 6-months post treatment
Coping Skills
12-week treatment phase, 3- and 6-months post treatment
Study Arms (2)
Therapeutic Education System (TES)
EXPERIMENTALParticipants 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-as-Usual (TAU)
OTHERParticipants randomized to TAU will receive standard treatment offered and prescribed, as usual, in the outpatient substance abuse treatment program.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
MCCA: Midwestern CT Council on Alcoholism
Danbury, Connecticut, 06810, United States
The Center for Drug Free Living
Orlando, Florida, 32856, United States
Hina Mauka
Waipahu, Hawaii, 96797, United States
Midtown Community Mental Health Center
Indianapolis, Indiana, 46208, United States
HARBEL Prevention and Recovery Center
Baltimore, Maryland, 21214, United States
Stanley Street Treatment and Resources (SSTAR)
Fall River, Massachusetts, 02720, United States
Project Outreach
West Hempstead, New York, 11552, United States
Willamette Family, Inc.
Eugene, Oregon, 97402, United States
Homeward Bound
Dallas, Texas, 75208, United States
Evergreen Manor
Everett, Washington, 98201, United States
Related Publications (5)
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.
PMID: 34366201DERIVEDMurphy 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.
PMID: 26880594DERIVEDCochran 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.
PMID: 25697725DERIVEDMitchell 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.
PMID: 25671593DERIVEDCochran 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.
PMID: 24708748DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Edward V Nunes, MD
NIDA Clinical Trials Network - Long Island Regional Node
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 14, 2010
First Posted
April 15, 2010
Study Start
April 1, 2010
Primary Completion
June 1, 2012
Study Completion
September 1, 2012
Last Updated
July 11, 2017
Record last verified: 2017-07