Back to resultsPerformance-based Reinforcement to Enhance Cognitive Remediation Therapy
Primary Purpose
Substance-Related Disorders, Mental Disorders
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Remediation Therapy - Standard
Cognitive Remediation Therapy plus Contingency Management
Sponsored by
About this trial
This is an interventional treatment trial for Substance-Related Disorders focused on measuring cognitive remediation therapy, substance abuse treatment
Eligibility Criteria
Inclusion Criteria:
- 18 to 60 years old
- Primary Alcohol and/or Cocaine Abuse/Dependence Diagnosis
- Abstinence from all drugs/alcohol for 30 days
- Mild cognitive impairment
- Sufficiently stable and plan to commit to 4 weeks of outpatient treatment
- Fluent in English and 6th grade reading ability
Exclusion Criteria:
- Severe cognitive impairment indicative of dementia
- Untreated bipolar or psychotic disorder
- Have current legal case pending such that incarceration during 4-week study is likely
Sites / Locations
- Substance Abuse Treatment Unit
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
CRT-S
CRT-CM
Arm Description
Cognitive Remediation Therapy - Standard
Cognitive Remediation Therapy plus Contingency Management
Outcomes
Primary Outcome Measures
Improvement in performance scores on computerized cognitive remediation tasks
Performance scores on various computerized cognitive remediation tasks will be measured repeatedly during the 4 week study. These scores include "time to completion", "number of errors", "number of words correctly recalled", and "percentage of task completed"
Secondary Outcome Measures
Improved cognitive function on neuropsychological tests
Change in cognitive function between baseline and post-treatment will be measured by performance on neuropsychological tests, such as Trail Making Test A & B, Wisconsin Card Sort Test, Digit Symbol Test from WAIS-IV, and the Continuous Performance Test-II (CPT-II).
Full Information
NCT ID
NCT01633138
First Posted
June 27, 2012
Last Updated
March 4, 2020
Sponsor
Yale University
Collaborators
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT01633138
Brief Title
Performance-based Reinforcement to Enhance Cognitive Remediation Therapy
Official Title
Pilot Study of Performance-based Reinforcement to Enhance Cognitive Remediation Therapy for Substance Users
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
National Institute on Drug Abuse (NIDA)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to investigate whether monetary reinforcement for performance will enhance the effects of cognitive remediation therapy for substance users seeking treatment at an outpatient facility.
Detailed Description
Forty individuals seeking treatment for an alcohol or cocaine use disorder at the Substance Abuse Treatment Unit (SATU) will be randomized to receive cognitive remediation therapy with or without additional compensation based on performance. Participants will use the computerized cognitive remediation program (PSSCogRehab 2012) three times per week for four weeks. The primary outcome measure will be an improved performance on the computerized tasks, with secondary outcomes of changes in cognitive functioning (e.g., attention, concentration, memory) as measured by neuropsychological tests between baseline and post-treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance-Related Disorders, Mental Disorders
Keywords
cognitive remediation therapy, substance abuse treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CRT-S
Arm Type
Active Comparator
Arm Description
Cognitive Remediation Therapy - Standard
Arm Title
CRT-CM
Arm Type
Experimental
Arm Description
Cognitive Remediation Therapy plus Contingency Management
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Remediation Therapy - Standard
Intervention Description
Computerized cognitive remediation therapy provided three times per week for four weeks
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Remediation Therapy plus Contingency Management
Intervention Description
Standard cognitive remediation therapy plus monetary incentives based on performance provided three times per week for four weeks.
Primary Outcome Measure Information:
Title
Improvement in performance scores on computerized cognitive remediation tasks
Description
Performance scores on various computerized cognitive remediation tasks will be measured repeatedly during the 4 week study. These scores include "time to completion", "number of errors", "number of words correctly recalled", and "percentage of task completed"
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Improved cognitive function on neuropsychological tests
Description
Change in cognitive function between baseline and post-treatment will be measured by performance on neuropsychological tests, such as Trail Making Test A & B, Wisconsin Card Sort Test, Digit Symbol Test from WAIS-IV, and the Continuous Performance Test-II (CPT-II).
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 to 60 years old
Primary Alcohol and/or Cocaine Abuse/Dependence Diagnosis
Abstinence from all drugs/alcohol for 30 days
Mild cognitive impairment
Sufficiently stable and plan to commit to 4 weeks of outpatient treatment
Fluent in English and 6th grade reading ability
Exclusion Criteria:
Severe cognitive impairment indicative of dementia
Untreated bipolar or psychotic disorder
Have current legal case pending such that incarceration during 4-week study is likely
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian D Kiluk, PhD
Organizational Affiliation
Yale School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Substance Abuse Treatment Unit
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Performance-based Reinforcement to Enhance Cognitive Remediation Therapy
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