Performance-based Reinforcement to Enhance Cognitive Remediation Therapy

• Sponsor: Yale University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01633138
• Collaborator: National Institute on Drug Abuse (NIDA) (NIH)
• Enrollment: 40
• Location: 1
• Arms: 2
• Duration (Months): 27
• Patients Per Site Per Month: 1.5

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Substance-Related Disorders; Mental Disorders	Behavioral: Cognitive Remediation Therapy - Standard; Behavioral: Cognitive Remediation Therapy plus Contingency Management	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Pilot Study of Performance-based Reinforcement to Enhance Cognitive Remediation Therapy for Substance Users
• Study Start Date: Sep 1, 2012
• Actual Primary Completion Date: Dec 1, 2014
• Actual Study Completion Date: Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

1. 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

1. 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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Substance Abuse Treatment Unit	New Haven	Connecticut	United States	06511

Sponsors and Collaborators

• Yale University
• National Institute on Drug Abuse (NIDA)

Investigators

• Principal Investigator: Brian D Kiluk, PhD, Yale School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yale University
• ClinicalTrials.gov Identifier: NCT01633138
• Other Study ID Numbers: 1205010253; P50DA009241
• First Posted: Jul 4, 2012
• Last Update Posted: Mar 9, 2020
• Last Verified: Mar 1, 2020

• Keywords provided by Yale University: cognitive remediation therapy; substance abuse treatment
• Additional relevant MeSH terms: Disease; Substance-Related Disorders; Mental Disorders

Study Results

No Results Posted as of Mar 9, 2020