The Effect of Cognitive Enhancement as a Precursor to Computer Based Training for Cognitive Behavioral Therapy (CBT4CBT)

Phase 1

Completed

• Conditions: Cocaine Use Disorder
• Interventions: Behavioral: Treatment As Usual (TAU); Behavioral: TAU plus Rapid Abstinence Initiation (RAI); Behavioral: TAU plus RAI plus Cognitive Control Training (CCT)

• Registration Number: NCT02174614
• Lead Sponsor: Yale University

Brief Summary

The investigators are conducting a randomized clinical trial of rapid abstinence initiation and cognitive control training as a precursor to our new web-based version of the CBT4CBT (Computer Based Training for Cognitive Behavioral Therapy) program to evaluate its effectiveness relative to standard outpatient counseling at the Midwestern Connecticut Council of Alcoholism (MCCA). CCT will be used to assess attention, working memory and inhibitory control and 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 cocaine abuse treatment.

Detailed Description

150 cocaine dependent individuals will be randomly assigned to one of 3 conditions delivered over 4 weeks in the context of intensive outpatient treatment. 1. Treatment as Usual (TAU), 2. rapid abstinence initiation (RAI) or 3. computerized cognitive control training with escalating reinforcement for improved performance on training tasks (CCT). All participants will then receive an 8 week trial of CBT4CBT in addition to TAU. Follow up evaluation thru 6 months posttreatment will assess durability and delayed emergence of treatment effects.

Study Timeline

• Study First Submitted: 2014-06-23
• Study First Submitted QC: 2014-06-24
• Study First Posted: 2014-06-25
• Study Start: 2015-04
• Primary Completion: 2020-08-31
• Study Completion: 2020-08-31
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-09
• Last Update Posted: 2020-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 99

Inclusion Criteria

• 18 years of age or older
• Meet current DSM-5 criteria for cocaine use disorder
• Are sufficiently stable for 12 weeks of outpatient treatment
• Are willing to provide locator information for follow-up
• Are fluent in English
• Have a 6th grade or higher reading level for completion of assessments

Exclusion Criteria

• Untreated bipolar or schizophrenic disorder
• Current suicide risk
• Have a legal case pending such that incarceration during the 12-week protocol is likely
• Are physically dependent on alcohol, opioids or benzodiazepines and require detoxification

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TAU plus Rapid Abstinence Initiation (RAI)	Treatment As Usual (TAU)	Treatment normally offered at this clinic which could include individual or group drug counseling sessions three times per week lasting three hours each time PLUS the chance to earn money for urine specimens that are negative for cocaine during the first 4 weeks of treatment
TAU plus RAI plus Cognitive Control Training (CCT)	TAU plus RAI plus Cognitive Control Training (CCT)	Treatment normally offered at this clinic which could include individual or group drug counseling sessions three times per week lasting three hours each time PLUS the chance to earn money for urine specimens that are negative for cocaine during the first 4 weeks of treatment PLUS sessions of computerized games 3 times per week for the first 4 weeks.
TAU plus Rapid Abstinence Initiation (RAI)	TAU plus Rapid Abstinence Initiation (RAI)	Treatment normally offered at this clinic which could include individual or group drug counseling sessions three times per week lasting three hours each time PLUS the chance to earn money for urine specimens that are negative for cocaine during the first 4 weeks of treatment
TAU plus RAI plus Cognitive Control Training (CCT)	Treatment As Usual (TAU)	Treatment normally offered at this clinic which could include individual or group drug counseling sessions three times per week lasting three hours each time PLUS the chance to earn money for urine specimens that are negative for cocaine during the first 4 weeks of treatment PLUS sessions of computerized games 3 times per week for the first 4 weeks.
TAU plus RAI plus Cognitive Control Training (CCT)	TAU plus Rapid Abstinence Initiation (RAI)	Treatment normally offered at this clinic which could include individual or group drug counseling sessions three times per week lasting three hours each time PLUS the chance to earn money for urine specimens that are negative for cocaine during the first 4 weeks of treatment PLUS sessions of computerized games 3 times per week for the first 4 weeks.
Treatment As Usual (TAU)	Treatment As Usual (TAU)	Treatment normally offered at this clinic which could include individual or group drug counseling sessions three times per week lasting three hours each time.

Primary Outcome Measures

Name	Time	Method
Reduction in cocaine use	12 weeks	Using urine and breathalyzer screening for negative cocaine and alcohol testing.

Secondary Outcome Measures

Name	Time	Method
Subjects ability to demonstrate coping skills acquisition through a computerized role-playing evaluation	12 weeks	Use of CBT4CBT program with acquisition of skills demonstrated through homework assignments.

Trial Locations

Locations (1)

MCCA; 🇺🇸 New Haven, Connecticut, United States