The Effect of Cognitive Enhancement as a Precursor to Computer Based Training for Cognitive Behavioral Therapy (CBT4CBT) (Project 1)

Yale University

Status and phase: Completed; Phase 1

Conditions: Cocaine Use Disorder

Treatments: Behavioral: TAU plus RAI plus Cognitive Control Training (CCT); Behavioral: TAU plus Rapid Abstinence Initiation (RAI); Behavioral: Treatment As Usual (TAU)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02174614

2P50DA009241-21 (U.S. NIH Grant/Contract)

1405013937

Details and patient eligibility

About

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.

Full 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.

Enrollment: 99 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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99 participants in 3 patient groups

Treatment As Usual (TAU)

Active Comparator group

Description:

Treatment normally offered at this clinic which could include individual or group drug counseling sessions three times per week lasting three hours each time.

Treatment:

Behavioral: Treatment As Usual (TAU)

TAU plus Rapid Abstinence Initiation (RAI)

Experimental group

Description:

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

Treatment:

Behavioral: Treatment As Usual (TAU)

Behavioral: TAU plus Rapid Abstinence Initiation (RAI)

TAU plus RAI plus Cognitive Control Training (CCT)

Experimental group

Description:

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:

Behavioral: Treatment As Usual (TAU)

Behavioral: TAU plus RAI plus Cognitive Control Training (CCT)

Behavioral: TAU plus Rapid Abstinence Initiation (RAI)