NCT01615497

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2012

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 6, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 8, 2012

Completed
5 months until next milestone

Study Start

First participant enrolled

November 1, 2012

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

March 9, 2020

Status Verified

March 1, 2020

Enrollment Period

2.6 years

First QC Date

June 6, 2012

Last Update Submit

March 4, 2020

Conditions

Keywords

cognitive behavior therapycomputer assisted instructionalcohol abuse therapyeducational resource design and development

Outcome Measures

Primary Outcomes (1)

  • Reduction in alcohol use

    8 weeks

Secondary Outcomes (1)

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

    8 weeks

Study Arms (3)

Standard Treatment as Usual (TAU)

ACTIVE COMPARATOR

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

Behavioral: Standard Treatment as Usual (TAU)

Web-based CBT4CBT for alcohol plus TAU

EXPERIMENTAL

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.

Behavioral: Web-based CBT4CBT for alcohol plus TAU

Web-based CBT with minimal clinical contact

ACTIVE COMPARATOR

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.

Behavioral: Web-based CBT with minimal clinical contact

Interventions

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.

Standard Treatment as Usual (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

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 10 minute check in with clinician.

Web-based CBT with minimal clinical contact

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Substance Abuse Treatment Unit (SATU)

New Haven, Connecticut, 06511, United States

Location

Substance Abuse Treatment Unit (SATU)

New Haven, Connecticut, 06519, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Alcoholism

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

AlcoholsOrganic Chemicals

Study Officials

  • Kathleen Carroll, PhD

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 6, 2012

First Posted

June 8, 2012

Study Start

November 1, 2012

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

March 9, 2020

Record last verified: 2020-03

Locations