Performance-based Reinforcement to Enhance Cognitive Remediation Therapy

Not Applicable

Completed

• Conditions: Substance-Related Disorders; Mental Disorders

• Registration Number: NCT01633138
• Lead Sponsor: Yale University

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.

Study Timeline

• Study First Submitted: 2012-06-27
• Study First Submitted QC: 2012-06-29
• Study First Posted: 2012-07-04
• Study Start: 2012-09
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-04
• Last Update Posted: 2020-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Improvement in performance scores on computerized cognitive remediation tasks	4 weeks	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

Name	Time	Method
Improved cognitive function on neuropsychological tests	4 weeks	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).

Trial Locations

Locations (1)

Substance Abuse Treatment Unit; 🇺🇸 New Haven, Connecticut, United States