Performance-based Reinforcement to Enhance Cognitive Remediation Therapy
This study is not yet open for participant recruitment.
Verified June 2012 by Yale University
Sponsor:
Yale University
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT01633138
First received: June 27, 2012
Last updated: June 29, 2012
Last verified: June 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Substance-Related Disorders Mental Disorders |
Behavioral: Cognitive Remediation Therapy - Standard Behavioral: Cognitive Remediation Therapy plus Contingency Management |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Pilot Study of Performance-based Reinforcement to Enhance Cognitive Remediation Therapy for Substance Users |
Resource links provided by NLM:
Further study details as provided by Yale University:
Primary Outcome Measures:
- Improvement in performance scores on computerized cognitive remediation tasks [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]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 [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]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).
| Estimated Enrollment: | 40 |
| Study Start Date: | September 2012 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: CRT-S
Cognitive Remediation Therapy - Standard
|
Behavioral: Cognitive Remediation Therapy - Standard
Computerized cognitive remediation therapy provided three times per week for four weeks
|
|
Experimental: CRT-CM
Cognitive Remediation Therapy plus Contingency Management
|
Behavioral: Cognitive Remediation Therapy plus Contingency Management
Standard cognitive remediation therapy plus monetary incentives based on performance provided three times per week for four weeks.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01633138
Contacts
| Contact: Brian D Kiluk, PhD | 203-974-5736 | |
| Contact: Elizabeth Vollono | 203-974-5732 |
Locations
| United States, Connecticut | |
| Substance Abuse Treatment Unit (SATU) | |
| New Haven, Connecticut, United States, 06511 | |
Sponsors and Collaborators
Yale University
Investigators
| Principal Investigator: | Brian D Kiluk, PhD | Yale School of Medicine |
More Information
No publications provided
| Responsible Party: | Yale University |
| ClinicalTrials.gov Identifier: | NCT01633138 History of Changes |
| Other Study ID Numbers: | 1205010253 |
| Study First Received: | June 27, 2012 |
| Last Updated: | June 29, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Yale University:
|
cognitive remediation therapy substance abuse treatment |
Additional relevant MeSH terms:
|
Mental Disorders Psychotic Disorders Substance-Related Disorders Schizophrenia and Disorders with Psychotic Features |
ClinicalTrials.gov processed this record on June 13, 2013