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Web-based CBT4CBT for Alcohol (CBT4CBT Etoh)

Primary Purpose

Alcohol Abuse or Dependence

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Standard Treatment as Usual (TAU)
Web-based CBT4CBT for alcohol plus TAU
Web-based CBT with minimal clinical contact
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

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

Eligibility Criteria

18 Years - 70 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 alcohol abuse or dependence.
  • 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 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 8-week protocol is likely.
  • Are physically dependent on alcohol, opioids or benzodiazepines

Sites / Locations

  • Substance Abuse Treatment Unit (SATU)
  • Substance Abuse Treatment Unit (SATU)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Active Comparator

Arm Label

Standard Treatment as Usual (TAU)

Web-based CBT4CBT for alcohol plus TAU

Web-based CBT with minimal clinical contact

Arm Description

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

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

A computerized program that teaches skills for stopping drug and alcohol use by increasing coping skills such as how to understand patterns of drug and alcohol use, coping with cravings, etc. plus 10 minute check in with clinician.

Outcomes

Primary Outcome Measures

Reduction in alcohol use

Secondary Outcome Measures

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

Full Information

First Posted
June 6, 2012
Last Updated
March 4, 2020
Sponsor
Yale University
Collaborators
National Institute on Drug Abuse (NIDA), National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT01615497
Brief Title
Web-based CBT4CBT for Alcohol
Acronym
CBT4CBT Etoh
Official Title
Computer Based Training in Cognitive Behavioral Therapy Web-based Delivery of CBT4CBT for Alcohol
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

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

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 (Computer Based Training for Cognitive Behavioral Therapy) program specifically designed for alcohol to evaluate its effectiveness relative to standard outpatient counseling at the Substance Abuse Treatment Unit (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
Ninety alcohol 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) standard outpatient counseling plus web-based CBT, or (3) web-based CBT4CBT with minimal clinical monitoring. Treatments will be delivered over an 8-week period with a six-month follow-up after termination of the study treatments. The primary outcome measures will be reduction in alcohol use (frequency of alcohol use by time, confirmed by urine toxicology screens and breathalyzers). 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
Alcohol Abuse or Dependence
Keywords
cognitive behavior therapy, computer assisted instruction, alcohol abuse therapy, educational resource design and development

7. Study Design

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

8. Arms, Groups, and Interventions

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 alcohol and substance abuse.
Arm Title
Web-based CBT4CBT for alcohol plus TAU
Arm Type
Experimental
Arm Description
A computerized program that teaches skills for stopping drug and alcohol use by increasing coping skills such as how to understand patterns of drug use, coping with cravings, etc. plus standard treatment as usual.
Arm Title
Web-based CBT with minimal clinical contact
Arm Type
Active Comparator
Arm Description
A computerized program that teaches skills for stopping drug and alcohol use by increasing coping skills such as how to understand patterns of drug and alcohol use, coping with cravings, etc. plus 10 minute check in with clinician.
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 alcohol and drug counseling sessions one time per week lasting one hour each time.
Intervention Type
Behavioral
Intervention Name(s)
Web-based CBT4CBT for alcohol plus TAU
Intervention Description
Subjects work with a computerized program that teaches skills for stopping alcohol and drug use and increasing coping skills. Computerized sessions are one time per week and last about one hour per session. Plus TAU
Intervention Type
Behavioral
Intervention Name(s)
Web-based CBT with minimal clinical contact
Intervention Description
Subjects work with a computerized program that teaches skills for stopping alcohol and drug use and increasing coping skills. Computerized sessions are one time per week and last about one hour per session. Plus 10 minute check in with clinician.
Primary Outcome Measure Information:
Title
Reduction in alcohol use
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Subjects ability to demonstrate coping skills through a computerized role-playing evaluation and homework
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 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 alcohol abuse or dependence. 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 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 8-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
06511
Country
United States
Facility Name
Substance Abuse Treatment Unit (SATU)
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
27488212
Citation
Kiluk BD, Devore KA, Buck MB, Nich C, Frankforter TL, LaPaglia DM, Yates BT, Gordon MA, Carroll KM. Randomized Trial of Computerized Cognitive Behavioral Therapy for Alcohol Use Disorders: Efficacy as a Virtual Stand-Alone and Treatment Add-On Compared with Standard Outpatient Treatment. Alcohol Clin Exp Res. 2016 Sep;40(9):1991-2000. doi: 10.1111/acer.13162. Epub 2016 Aug 4.
Results Reference
derived

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Web-based CBT4CBT for Alcohol

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