Web-based CBT4CBT for Alcohol

NCT ID: NCT01615497

Last Updated: 2020-03-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2015-06-30

Brief Summary

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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

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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.

Conditions

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Alcohol Abuse or Dependence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Standard Treatment as Usual (TAU)

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

Group Type ACTIVE_COMPARATOR

Standard Treatment as Usual (TAU)

Intervention Type BEHAVIORAL

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.

Web-based CBT4CBT for alcohol plus TAU

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.

Group Type EXPERIMENTAL

Web-based CBT4CBT for alcohol plus TAU

Intervention Type BEHAVIORAL

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

Web-based CBT with minimal clinical contact

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.

Group Type ACTIVE_COMPARATOR

Web-based CBT with minimal clinical contact

Intervention Type BEHAVIORAL

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.

Interventions

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Standard Treatment as Usual (TAU)

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

Web-based CBT4CBT for alcohol plus TAU

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

Web-based CBT with minimal clinical contact

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role collaborator

Yale University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kathleen Carroll, PhD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

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Substance Abuse Treatment Unit (SATU)

New Haven, Connecticut, United States

Site Status

Substance Abuse Treatment Unit (SATU)

New Haven, Connecticut, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 27488212 (View on PubMed)

Other Identifiers

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R21AA021405-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1204010157

Identifier Type: -

Identifier Source: org_study_id

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