The Effect of Cognitive Enhancement as a Precursor to Computer Based Training for Cognitive Behavioral Therapy (CBT4CBT)
Project 1
2 other identifiers
interventional
99
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Apr 2015
Longer than P75 for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 23, 2014
CompletedFirst Posted
Study publicly available on registry
June 25, 2014
CompletedStudy Start
First participant enrolled
April 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2020
CompletedOctober 14, 2020
October 1, 2020
5.4 years
June 23, 2014
October 9, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Reduction in cocaine use
Using urine and breathalyzer screening for negative cocaine and alcohol testing.
12 weeks
Secondary Outcomes (1)
Subjects ability to demonstrate coping skills acquisition through a computerized role-playing evaluation
12 weeks
Other Outcomes (1)
Increased cognitive function and working memory
12 weeks
Study Arms (3)
Treatment As Usual (TAU)
ACTIVE COMPARATORTreatment normally offered at this clinic which could include individual or group drug counseling sessions three times per week lasting three hours each time.
TAU plus Rapid Abstinence Initiation (RAI)
EXPERIMENTALTreatment 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)
EXPERIMENTALTreatment 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.
Interventions
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 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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Yale Universitylead
- National Institute on Drug Abuse (NIDA)collaborator
Study Sites (2)
MCCA
Bridgeport, Connecticut, 06601, United States
MCCA
New Haven, Connecticut, 06511, United States
MeSH Terms
Interventions
Study Officials
- STUDY DIRECTOR
Brian Kiluk, PhD
Yale University
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
June 23, 2014
First Posted
June 25, 2014
Study Start
April 1, 2015
Primary Completion
August 31, 2020
Study Completion
August 31, 2020
Last Updated
October 14, 2020
Record last verified: 2020-10