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Computer Based Training in CBT in Primary Care

Primary Purpose

Substance Abuse

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Standard Treatment As Usual (TAU)
CBT4CBT program
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Substance Abuse

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Yale New Haven Hospital St Raphael's Campus

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Standard treatment as usual (TAU)

TAU plus CBT4CBT program

Arm Description

Treatment normally offered at this primary care clinic

Treatment normally offered at this clinic PLUS 8 weeks of CBT4CBT computerized therapy.

Outcomes

Primary Outcome Measures

retention in treatment
subjects returning for treatment at primary care unit and completing CBT4CBT program for those assigned
reduction in drug use
Using urine and breathalyzer screening for negative drug and alcohol testing

Secondary Outcome Measures

Full Information

First Posted
January 4, 2017
Last Updated
September 11, 2018
Sponsor
Yale University
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT03013478
Brief Title
Computer Based Training in CBT in Primary Care
Official Title
Computer Based Training in CBT in Primary Care
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
November 2016 (Actual)
Primary Completion Date
August 31, 2018 (Actual)
Study Completion Date
August 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Abuse

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard treatment as usual (TAU)
Arm Type
No Intervention
Arm Description
Treatment normally offered at this primary care clinic
Arm Title
TAU plus CBT4CBT program
Arm Type
Active Comparator
Arm Description
Treatment normally offered at this clinic PLUS 8 weeks of CBT4CBT computerized therapy.
Intervention Type
Behavioral
Intervention Name(s)
Standard Treatment As Usual (TAU)
Intervention Description
Treatment normally offered at this primary care clinic
Intervention Type
Behavioral
Intervention Name(s)
CBT4CBT program
Primary Outcome Measure Information:
Title
retention in treatment
Description
subjects returning for treatment at primary care unit and completing CBT4CBT program for those assigned
Time Frame
0 - 8 weeks
Title
reduction in drug use
Description
Using urine and breathalyzer screening for negative drug and alcohol testing
Time Frame
0 - 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathleen M Carroll, PhD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale New Haven Hospital St Raphael's Campus
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06604
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
32371660
Citation
Tetrault JM, Holt SR, Cavallo DA, O'Connor PG, Gordon MA, Corvino JK, Nich C, Carroll KM. Computerized Cognitive Behavioral Therapy for Substance Use Disorders in a Specialized Primary Care Practice: A Randomized Feasibility Trial to Address the RT Component of SBIRT. J Addict Med. 2020 Dec;14(6):e303-e309. doi: 10.1097/ADM.0000000000000663.
Results Reference
derived

Learn more about this trial

Computer Based Training in CBT in Primary Care

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