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Computer-assisted, Evidence-based Psychosocial InterventionCPTNCT01277939

CPT for Offenders With SUD

A study testing Therapeutic Education System (TES) in people with Computer-assisted, Evidence-based Psychosocial Intervention and for Substance Abuse Treatment, run by National Development and Research Institutes, Inc. at 10 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Therapeutic Education System (TES)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
376 participants
Where
10 sitesUnited States
Study dates
Sep 2009to Aug 2012
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

United States10 sites
  • Airway Heights Corrections Center

    Airway Heights, Washington, 99001

  • SCI Cambridge Springs

    Cambridge Springs, Pennsylvania, 16403

  • Colorado Territorial Correctional Facility

    Cañon City, Colorado, 81215

  • Four Mile Correctional Center

    Cañon City, Colorado, 81215

  • Fremont Correctional Facility

    Cañon City, Colorado, 81215

  • Denver Women's Correctional Facility

    Denver, Colorado, 80239

  • Blackburn Correctional Complex

    Lexington, Kentucky, 40511

  • Trinidad Correctional Facility

    Model, Colorado, 81509

  • La Vista Correctional Facility

    Pueblo, Colorado, 81002

  • Sterling Correctional Facility

    Sterling, Colorado, 80751

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Therapeutic Education System (TES), Standard Care

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Therapeutic Education System (TES)Behavioural

    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).

  • Standard CareBehavioural

    Psycho-educational and psycho-social approaches to substance use disorders (commonly offered in prison settings) delivered by counselors in group formats.

Study groups in NCT01277939
Study groupRoleWhat they receive
Therapeutic Education System (TES)ExperimentalExperimental (E) condition, the Therapeutic Education System (TES) delivered via effective informational technologies and multimedia learning tools.
Receives: Behavioral: Therapeutic Education System (TES)
Standard CareActive comparatorThe 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.
Receives: Behavioral: Standard Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time Line Follow Back for Drug and Alcohol Use (Sobell et al., 1996)

    Measure for substance use.

    Measured: 6 months post-prison release

  2. Urinalysis

    To detect any change in illicit drug use.

    Measured: 6 months post-prison release

  3. Risk Behavior Survey (Booth et al., 1993)

    To assess both drug-related and sex-related HIV risk behavior.

    Measured: 6 months post-prison release

  4. DOC record systems

    To provide the reincarceration status of each participant.

    Measured: At an average of 11 months post-prison release

Secondary outcomes (5)
  1. 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

    Measured: 6 months post-prison release

  2. Addiction Severity Index-Lite

    Measures areas of health status improvement, psychological status, family/social relationships, and employment. (www.tresearch.org)

    Measured: 6 months post-prison release

  3. The Treatment Services Review instrument (McLellan et al., www.tresearch.org)

    Used to investigate the role of treatment services received post-release (in aftercare).

    Measured: 6 months post-prison release

  4. Brief Drug Abuse Treatment Cost Analysis Program (BriefDATCAP)

    Measures for the cost effectiveness analyses.

    Measured: 6 months post-prison release

  5. EuroQol EQ5D (QOL) (the EuroQol Group, 1990)

    Describes and value health-related quality of life and for constructing Quality-Adjusted Life Year estimates (QALYs).

    Measured: 6 months post-prison release

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jan 2011 (estimated)
  2. Study startSep 2009
  3. Primary completionAug 2011
  4. Study completionAug 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
376 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01277939
Sponsor's protocol ID
NDRI-612
Other IDs
1RC2DA028967
Acronym
CPT
Status last verified
Aug 2013
First submitted
12 Jan 2011
Last updated
2 Sep 2013
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Therapeutic Education System (TES) in people with Computer-assisted, Evidence-based Psychosocial Intervention and for Substance Abuse Treatment, run by National Development and Research Institutes, Inc. at 10 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time Line Follow Back for Drug and Alcohol Use (Sobell et al., 1996) (time frame: 6 months post-prison release). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2013.

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