CPT for Offenders With SUD (CPT)

Computerized Psychosocial Treatment for Offenders With Substance Use Disorders

This study will evaluate the comparative effectiveness of Therapeutic Education System (TES), a computer-based, psychosocial treatment program, relative to standard care when offered to individuals with substance use disorders in prison settings. The study will assess the comparative effectiveness of these interventions primarily by examining changes in: (1) substance use (e.g., weeks of abstinence), (2) HIV risk behavior (evaluated as both sex-related and drug-related HIV risk behavior) and (3) reincarceration rates. The study will also examine the extent to which these interventions improve psychosocial functioning (e.g., employment, health, and psychological status) and quality of life, and promote relevant skills acquisition (e.g., improve communication skills, reduce "criminal thinking"). The investigators predict significantly better outcomes for E vs. C due to TES' research-based content and use of proven informational technologies.

Study Overview

• Status: Completed
• Conditions: Computer-assisted, Evidence-based Psychosocial Intervention; for Substance Abuse Treatment
• Intervention / Treatment: Behavioral: Therapeutic Education System (TES); Behavioral: Standard Care

Detailed Description

The majority of individuals in criminal justice settings across the U.S. have a critical need for science-based, psychosocial treatment that targets substance use and HIV risk behavior. The investigative team has developed and demonstrated the efficacy of an interactive, computer-based, psychosocial treatment pro-gram, the Therapeutic Education System (TES), which can answer this need. TES is theoretically grounded in evidence-based psychosocial treatments (Community Reinforcement Approach and Cognitive Behavioral Therapy), and employs state-of-the-art, proven informational technologies and multimedia learning tools to promote skills acquisition, experiential learning and behavioral change. This computer-based therapeutic tool allows complex interventions to be delivered with fidelity to the evidence-based model and at low cost due to its self-directed nature (e.g., minimal staff time/training needed), thus offering considerable potential for future sustainability and dissemination within criminal justice systems.

The study employs random assignment of incarcerated male and female offenders with substance use disorders (N=526) to either (1) TES (N=263), or (2) Standard Care (N=263), in a multi-site trial conducted in 8 prison substance abuse programs. Along with NDRI (the applicant organization), the collaborating study sites (University of California Los Angeles, Temple University, and the University of Kentucky) operate Research Centers that belong to the Criminal Justice Drug Abuse Treatment Studies (CJDATS) network, a NIDA-funded cooperative agreement, which has established relationships with criminal justice partners from Departments of Corrections across the U.S. Aim 1 is to test the comparative effectiveness of TES vs. Standard Care on measures of drug use (e.g., weeks of abstinence) and HIV risk behavior (both sex-related and drug-related HIV risk behavior) at 3- and 6-months post prison discharge, as well as on reincarceration rates using official Department of Corrections records. Aim 2 is to evaluate the cost and cost-effectiveness of TES relative to standard care. The investigators predict that TES will be significantly more effective and cost effective than Standard Care.

The project is significant in its use of an innovative, computer-based technology and in its potential to produce a major increase in the effective and cost-effective delivery of science-based psychosocial treatment to substance-abusing offenders in prison, and thereby make a considerable public health contribution. Thus, funding the proposed 2-year project can markedly accelerate the pace and achievement of research and dissemination efforts to meet the needs of the U.S. correctional community by providing effective and practical treatment interventions for its large substance-abusing population.

• Study Type: Interventional
• Enrollment (Actual): 376
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Canon City, Colorado, United States, 81215
      • Colorado Territorial Correctional Facility
    • Canon City, Colorado, United States, 81215
      • Four Mile Correctional Center
    • Canon City, Colorado, United States, 81215
      • Fremont Correctional Facility
    • Denver, Colorado, United States, 80239
      • Denver Women's Correctional Facility
    • Model, Colorado, United States, 81509
      • Trinidad Correctional Facility
    • Pueblo, Colorado, United States, 81002
      • La Vista Correctional Facility
    • Sterling, Colorado, United States, 80751
      • Sterling Correctional Facility
  • Kentucky
    • Lexington, Kentucky, United States, 40511
      • Blackburn Correctional Complex
  • Pennsylvania
    • Cambridge Springs, Pennsylvania, United States, 16403
      • SCI Cambridge Springs
  • Washington
    • Airway Heights, Washington, United States, 99001
      • Airway Heights Corrections Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• individual's parole eligibility date or mandatory release date must be scheduled to occur within a minimum of 4 months (to allow intake an treatment to be completed) and a maximum of 6 months (to ensure that their release follows completion of their treatment such that sufficient time remains for post-prison follow-up interviews to occur within the two-year project timeframe)
• the state criminal justice system must have identified the individual to have a substance use disorder that requires a substance abuse intervention
• the individual must give their informed consent

Exclusion Criteria:

• the individual must not already be participating in substance abuse treatment
• the individual must speak English, as TES is now only available in English

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Therapeutic Education System (TES); Experimental (E) condition, the Therapeutic Education System (TES) delivered via effective informational technologies and multimedia learning tools.	Behavioral: Therapeutic Education System (TES); Therapeutic Education System (TES) is an interactive, computer-based, psychosocial treatment program. TES is theoretically grounded in evidence-based psychosocial treatments (Community Reinforcement Approach and Cognitive Behavioral Therapy).
Active Comparator: Standard Care; The Control (C) condition, Standard Care, consisting of psycho-educational and psycho-social approaches to substance use disorders (commonly offered in prison settings) delivered by counselors in group formats.	Behavioral: Standard Care; Psycho-educational and psycho-social approaches to substance use disorders (commonly offered in prison settings) delivered by counselors in group formats.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time Line Follow Back for Drug and Alcohol Use (Sobell et al., 1996)	Measure for substance use.	6 months post-prison release
Urinalysis	To detect any change in illicit drug use.	6 months post-prison release
Risk Behavior Survey (Booth et al., 1993)	To assess both drug-related and sex-related HIV risk behavior.	6 months post-prison release
DOC record systems	To provide the reincarceration status of each participant.	At an average of 11 months post-prison release

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Coping Strategies Scale	Measures skills acquisition, such as problem solving and dealing with urges to use substances of abuse (Litt et al., 2005), and psychosocial functioning	6 months post-prison release
Addiction Severity Index-Lite	Measures areas of health status improvement, psychological status, family/social relationships, and employment. (www.tresearch.org)	6 months post-prison release
The Treatment Services Review instrument (McLellan et al., www.tresearch.org)	Used to investigate the role of treatment services received post-release (in aftercare).	6 months post-prison release
Brief Drug Abuse Treatment Cost Analysis Program (BriefDATCAP)	Measures for the cost effectiveness analyses.	6 months post-prison release
EuroQol EQ5D (QOL) (the EuroQol Group, 1990)	Describes and value health-related quality of life and for constructing Quality-Adjusted Life Year estimates (QALYs).	6 months post-prison release

Collaborators and Investigators

• Sponsor: National Development and Research Institutes, Inc.
• Collaborators: National Institute on Drug Abuse (NIDA); University of California, Los Angeles; University of Miami; Temple University; University of Kentucky
• Investigators: Principal Investigator: Stan Sacks, PhD, National Development & Research Institutes

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (Actual): August 1, 2011
• Study Completion (Actual): August 1, 2012

Study Registration Dates

• First Submitted: January 12, 2011
• First Submitted That Met QC Criteria: January 14, 2011
• First Posted (Estimate): January 17, 2011

Study Record Updates

• Last Update Posted (Estimate): September 2, 2013
• Last Update Submitted That Met QC Criteria: August 29, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders
• Other Study ID Numbers: NDRI-612; 1RC2DA028967 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No