Performance-based Reinforcement to Enhance Cognitive Remediation Therapy

Substance-Related Disorders Clinical Trial

Official title:

Pilot Study of Performance-based Reinforcement to Enhance Cognitive Remediation Therapy for Substance Users

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01633138
• Other study ID #: 1205010253
• Secondary ID: P50DA009241
• Status: Completed
• Phase: N/A
• Start date: September 2012
• Est. completion date: December 2014

Study information

• Verified date: March 2020
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Disease
• Mental Disorders
• Substance-Related Disorders

Intervention

Behavioral:
• Cognitive Remediation Therapy - Standard
Computerized cognitive remediation therapy provided three times per week for four weeks
• Cognitive Remediation Therapy plus Contingency Management
Standard cognitive remediation therapy plus monetary incentives based on performance provided three times per week for four weeks.

Locations

Country	Name	City	State
United States	Substance Abuse Treatment Unit	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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"	4 weeks
Secondary	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).	4 weeks

External Links

•   Related Info