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Computer Based Training in Cognitive Behavioral Therapy Web-based (Man VS Machine)

Primary Purpose

Substance Abuse

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Standard Treatment As Usual (TAU)
Individual clinician-provided CBT
CBT4CBT
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Substance Abuse focused on measuring cognitive behavior therapy, computer assisted instruction, drug abuse therapy, educational resource design and development

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Substance Abuse Treatment Unit (SATU)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Active Comparator

Arm Label

Individual clinician-provided CBT

CBT4CBT

Standard Treatment as Usual (TAU)

Arm Description

Individual treatment provided by a trained Cognitive Behavioral Therapy (CBT)clinician who will cover the same skills provided by the CBT4CBT computer program.

A computerized program that teaches skills for stopping drug use and increasing coping skills such as how to understand patterns of drug use, coping with cravings, etc.

Treatment that would normally be received at the clinic typically consisting of individual or group counseling sessions focusing on substance abuse.

Outcomes

Primary Outcome Measures

Reduction in drug abuse

Secondary Outcome Measures

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

Full Information

First Posted
September 26, 2011
Last Updated
March 4, 2020
Sponsor
Yale University
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT01442597
Brief Title
Computer Based Training in Cognitive Behavioral Therapy Web-based
Acronym
Man VS Machine
Official Title
Computer Based Training in Cognitive Behavioral Therapy Web-based
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
January 2018 (Actual)
Study Completion Date
January 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
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Abuse
Keywords
cognitive behavior therapy, computer assisted instruction, drug abuse therapy, educational resource design and development

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
164 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Individual clinician-provided CBT
Arm Type
Active Comparator
Arm Description
Individual treatment provided by a trained Cognitive Behavioral Therapy (CBT)clinician who will cover the same skills provided by the CBT4CBT computer program.
Arm Title
CBT4CBT
Arm Type
Experimental
Arm Description
A computerized program that teaches skills for stopping drug use and increasing coping skills such as how to understand patterns of drug use, coping with cravings, etc.
Arm Title
Standard Treatment as Usual (TAU)
Arm Type
Active Comparator
Arm Description
Treatment that would normally be received at the clinic typically consisting of individual or group counseling sessions focusing on substance abuse.
Intervention Type
Behavioral
Intervention Name(s)
Standard Treatment As Usual (TAU)
Intervention Description
Treatment normally offered at this clinic which could include individual or group drug counseling sessions one time per week last one hour each time.
Intervention Type
Behavioral
Intervention Name(s)
Individual clinician-provided CBT
Intervention Description
Individual drug counseling sessions with trained clinicians using CBT one time per week last one hour per session.
Intervention Type
Behavioral
Intervention Name(s)
CBT4CBT
Intervention Description
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 Outcome Measure Information:
Title
Reduction in drug abuse
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Subjects ability to demonstrate coping skills through a computerized role-playing evaluation
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathleen Carroll, PhD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Substance Abuse Treatment Unit (SATU)
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
29792052
Citation
Kiluk BD, Nich C, Buck MB, Devore KA, Frankforter TL, LaPaglia DM, Muvvala SB, Carroll KM. Randomized Clinical Trial of Computerized and Clinician-Delivered CBT in Comparison With Standard Outpatient Treatment for Substance Use Disorders: Primary Within-Treatment and Follow-Up Outcomes. Am J Psychiatry. 2018 Sep 1;175(9):853-863. doi: 10.1176/appi.ajp.2018.17090978. Epub 2018 May 24.
Results Reference
derived

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Computer Based Training in Cognitive Behavioral Therapy Web-based

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