Trial record 18 of 519 for:    Open Studies | "Substance-Related Disorders"

Performance-based Reinforcement to Enhance Cognitive Remediation Therapy

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Yale University
Sponsor:
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT01633138
First received: June 27, 2012
Last updated: April 1, 2014
Last verified: January 2013
  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 2014
Estimated Primary Completion Date: December 2014 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01633138

Contacts
Contact: Brian D Kiluk, PhD 203-974-5736
Contact: Matt Buck 203-974-5721

Locations
United States, Connecticut
Substance Abuse Treatment Unit Recruiting
New Haven, Connecticut, United States, 06511
Contact: Matt Buck    203-974-5721      
Principal Investigator: Brian D Kiluk, PhD         
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Brian D Kiluk, PhD Yale School of Medicine
  More Information

Additional 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: April 1, 2014
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
Disease
Schizophrenia and Disorders with Psychotic Features
Chemically-Induced Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on September 22, 2014