Computer Based Training in Cognitive Behavioral Therapy Web-based

NCT ID: NCT01442597

Last Updated: 2020-03-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 164 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2018-01-31

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.

Conditions

Substance Abuse

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Individual clinician-provided CBT

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

Group Type: ACTIVE_COMPARATOR

Individual clinician-provided CBT

Intervention Type: BEHAVIORAL

Individual drug counseling sessions with trained clinicians using CBT one time per week last one hour per session.

CBT4CBT

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.

Group Type: EXPERIMENTAL

CBT4CBT

Intervention Type: BEHAVIORAL

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.

Standard Treatment as Usual (TAU)

Treatment that would normally be received at the clinic typically consisting of individual or group counseling sessions focusing on 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 drug counseling sessions one time per week last one hour each time.

Interventions

Individual clinician-provided CBT

Individual drug counseling sessions with trained clinicians using CBT one time per week last one hour per session.

Intervention Type: BEHAVIORAL

CBT4CBT

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.

Intervention Type: BEHAVIORAL

Standard Treatment As Usual (TAU)

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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kathleen Carroll, PhD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Substance Abuse Treatment Unit (SATU)

New Haven, Connecticut, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 29792052 (View on PubMed)

Other Identifiers

2P50DA009241-21

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1004006632

Identifier Type: -

Identifier Source: org_study_id