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OpenTrials
Completed

NCT Number: NCT01442597

Computer Based Training in Cognitive Behavioral Therapy Web-based

The investigators are conducting a randomized clinical trial of our new web-based version of the CBT4CBT program to evaluate its effectiveness relative to standard outpatient counseling at SATU. The computer-based training program (CBT4CBT) focuses on teaching basic coping skills, presenting examples of effective use of coping skills in a number of realistic situations in video form, and providing opportunities for patients to practice and review new skills while receiving substance abuse treatment.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Substance Abuse Treatment Unit (SATU)

New Haven, Connecticut, 06510, United States

About this study

One hundred eighty drug-using individuals seeking treatment at the Substance Abuse Treatment Unit (SATU) of the Connecticut Mental Health Center will be randomized to (1) standard outpatient counseling at SATU (typically consisting of weekly group counseling), (2) individual clinician delivered CBT, or (3) web-based CBT4CBT. Treatments will be delivered over a 12-week period with a six-month follow-up after termination of the study treatments. The primary outcome measures will be reduction in substance use (frequency of drug use by time, confirmed by urine toxicology screens). Secondary outcomes will include treatment utilization and cost, several measures intended to detect whether web-based CBT4CBT retains key characteristics of traditional clinician-administered CBT (e.g., acquisition of coping skills, use of change strategies), participant characteristics which will be evaluated as potential moderators of outcome, as well as participant satisfaction and treatment credibility.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Are 18 years of age or older.
  • Are applying for outpatient, non-agonist substance abuse treatment at SATU.
  • Meet current DSM-IV criteria for cocaine, marijuana,opioid,or amphetamine dependence.
  • Are sufficiently stable for 12 weeks of outpatient treatment.
  • Can commit to 12 weeks of treatment and are willing to be randomized to treatment
  • Are willing to provide locator information for follow-up.
  • Are fluent in English and have a 6th grader or higher reading level

Exclusion criteria

  • Have an untreated bipolar or schizophrenic disorder.
  • Who have a current legal case pending such that incarceration during 12-week protocol is likely.
  • Are physically dependent on alcohol, opioids or benzodiazepines

Treatment and study plan

Standard Treatment as Usual (TAU)

Behavioral

Treatment normally offered at this clinic which could include individual or group drug counseling sessions one time per week last one hour each time.

Individual clinician-provided CBT

Behavioral

Individual drug counseling sessions with trained clinicians using CBT one time per week last one hour per session.

CBT4CBT

Behavioral

Subjects work with a computerized program that teaches skills for stopping drug use and increasing coping skills. Computerized sessions are one time per week and last about one hour per session.

Primary outcomes

  1. Reduction in drug abuse

    Time frame: 12 weeks

Secondary outcomes

  1. Subjects ability to demonstrate coping skills through a computerized role-playing evaluation

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Acronym: Man VS Machine

Important dates

Study start
2012
Primary completion
2018
Study completion
2018
First posted
Sep 28, 2011
Registry last updated
Mar 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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