NCT01442597

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
164

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2012

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

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

September 26, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 28, 2011

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2012

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

March 6, 2020

Status Verified

March 1, 2020

Enrollment Period

6 years

First QC Date

September 26, 2011

Last Update Submit

March 4, 2020

Conditions

Substance Abuse

Keywords

cognitive behavior therapycomputer assisted instructiondrug abuse therapyeducational resource design and development

Outcome Measures

Primary Outcomes (1)

  • Reduction in drug abuse

    12 weeks

Secondary Outcomes (1)

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

    12 weeks

Study Arms (3)

Individual clinician-provided CBT

ACTIVE COMPARATOR

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

Behavioral: Individual clinician-provided CBT

CBT4CBT

EXPERIMENTAL

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.

Behavioral: CBT4CBT

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 substance abuse.

Behavioral: Standard Treatment As Usual (TAU)

Interventions

Standard Treatment As Usual (TAU)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.

Standard Treatment as Usual (TAU)
Individual clinician-provided CBTBEHAVIORAL

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

Individual clinician-provided CBT
CBT4CBTBEHAVIORAL

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.

CBT4CBT

Eligibility Criteria

Age18 Years - 65 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 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Substance Abuse Treatment Unit (SATU)

New Haven, Connecticut, 06510, United States

Location

Related Publications (1)

  • 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.

    PMID: 29792052DERIVED

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Officials

  • Kathleen Carroll, PhD

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 26, 2011

First Posted

September 28, 2011

Study Start

January 1, 2012

Primary Completion

January 1, 2018

Study Completion

January 1, 2018

Last Updated

March 6, 2020

Record last verified: 2020-03

Locations

US(1)