Computer Based Training in CBT in Primary Care

September 11, 2018 updated by: Yale University
To conduct an 8-week randomized trial evaluating the feasibility and efficacy of adding CBT4CBT to treatment as usual in a community based primary care program in a population of 60 individuals who meet current DSM criteria for substance use disorder other than nicotine.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The investigators will conduct an initial evaluation of the computer program as an enhancement of treatment as usual in a community-based primary care clinic. Sixty individuals with a current DSM-IV alcohol or substance use disorder will be randomly assigned to either (1) treatment as usual, or (2) treatment as usual plus exposure to the 'CBT for CBT' program over a period of 8 weeks. Primary outcomes will be retention in treatment and reduction in drug use over 8 weeks. Secondary outcomes include treatment utilization

Study Type

Interventional

Enrollment (Actual)

58

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06604
        • Yale New Haven Hospital St Raphael's Campus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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:

  • Are 18 years of age or older.
  • Are applying for outpatient substance abuse treatment
  • Meet current DSM-IV criteria for cocaine, marijuana, opioid, alcohol or other stimulant use disorder
  • Are sufficiently stable for 8 weeks of outpatient treatment
  • Can commit to 8 weeks of treatment and are willing to be randomized to treatment
  • Are willing to provide locator information.

Exclusion Criteria:

  • Have an untreated bipolar or schizophrenic disorder
  • Have a current legal case pending such that incarceration during the 8 week protocol is likely
  • Are in need of detoxification from alcohol, opioids or benzodiazepines

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Standard treatment as usual (TAU)
Treatment normally offered at this primary care clinic
ACTIVE_COMPARATOR: TAU plus CBT4CBT program
Treatment normally offered at this clinic PLUS 8 weeks of CBT4CBT computerized therapy.
Behavioral: Standard Treatment As Usual (TAU)
Treatment normally offered at this primary care clinic
Behavioral: CBT4CBT program

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
retention in treatment
Time Frame: 0 - 8 weeks
subjects returning for treatment at primary care unit and completing CBT4CBT program for those assigned
0 - 8 weeks
reduction in drug use
Time Frame: 0 - 8 weeks
Using urine and breathalyzer screening for negative drug and alcohol testing
0 - 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

  • Principal Investigator: Kathleen M Carroll, PhD, Yale University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 1, 2016

Primary Completion (ACTUAL)

August 31, 2018

Study Completion (ACTUAL)

August 31, 2018

Study Registration Dates

First Submitted

January 4, 2017

First Submitted That Met QC Criteria

January 5, 2017

First Posted (ESTIMATE)

January 6, 2017

Study Record Updates

Last Update Posted (ACTUAL)

September 12, 2018

Last Update Submitted That Met QC Criteria

September 11, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1607018152
  • R01DA030369 (NIH)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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