Project 1: The Effect of Cognitive Enhancement as a Precursor to Computer Based Training for Cognitive Behavioral Therapy (CBT4CBT)
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: 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. |
Behavioral: 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.
|
| Experimental: 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 |
Behavioral: 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.
Behavioral: 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 followed by 8 weeks of CBT4CBT computerized therapy.
|
| Experimental: 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. |
Behavioral: 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.
Behavioral: 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 followed by 8 weeks of CBT4CBT computerized therapy.
Behavioral: 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 cognitive control training (CCT) 3 times per week for the first 4 weeks followed by 8 weeks of CBT4CBT computerized therapy.
|
Outcome Measures
Primary Outcome Measures
- Reduction in cocaine use [12 weeks]
Using urine and breathalyzer screening for negative cocaine and alcohol testing.
Secondary Outcome Measures
- 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.
Other Outcome Measures
- Increased cognitive function and working memory [12 weeks]
development of skills used in attention, working memory and inhibitory control as demonstrated through an extensive assessment battery.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
18 years of age or older
-
Meet current DSM-5 criteria for cocaine use disorder
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Are sufficiently stable for 12 weeks of outpatient treatment
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Are willing to provide locator information for follow-up
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Are fluent in English
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Have a 6th grade or higher reading level for completion of assessments
Exclusion Criteria:
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Untreated bipolar or schizophrenic disorder
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Current suicide risk
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Have a legal case pending such that incarceration during the 12-week protocol is likely
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Are physically dependent on alcohol, opioids or benzodiazepines and require detoxification
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | MCCA | Bridgeport | Connecticut | United States | 06601 |
| 2 | MCCA | New Haven | Connecticut | United States | 06511 |
Sponsors and Collaborators
- Yale University
- National Institute on Drug Abuse (NIDA)
Investigators
- Study Director: Brian Kiluk, PhD, Yale University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 1405013937
- 2P50DA009241-21