Cognitive Remediation in Early Substance Abuse Treatment

Tracking Information
First Submitted Date ICMJE	June 2, 2006
First Posted Date ICMJE	June 6, 2006
Last Update Posted Date	June 18, 2009
Study Start Date ICMJE	August 2005
Actual Primary Completion Date	August 2007 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: June 4, 2008)	Cognitive improvement and adherence to substance abuse treatment [ Time Frame: 6 month follow-up ]
Original Primary Outcome Measures ICMJE; (submitted: June 2, 2006)	Post-treatment neuropsychological testing, 6-month follow-up testing
Change History	Complete list of historical versions of study NCT00334217 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE	Not Provided
Original Secondary Outcome Measures ICMJE; (submitted: June 2, 2006)	Alcohol use disorder inventory, Alcohol/Substance Use Inventory, Beck Depression Inventory
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Cognitive Remediation in Early Substance Abuse Treatment
Official Title ICMJE	Cognitive Remediation in the Initial Phase of Substance Abuse Treatment: Feasibility and Efficacy
Brief Summary	This study is for the purpose of determining whether cognitive remediation may improve cognition and treatment response in patients entering substance abuse day treatment
Detailed Description	Background: Patients entering substance abuse treatment display cognitive deficits that may reduce their ability to benefit from their treatment. While there is considerable variety in the severity and types of cognitive impairment found in newly recovering patients, problems with attention, memory and executive function are very common. Since treatment requires sustained attention, remembering what is learned, integrating that knowledge and applying it to recovery, impairment in underlying cognitive processes makes successful treatment less likely. Although cognitive functioning improves with sustained sobriety, it is during the early phase of recovery that most patients receive the most intensive treatment. Recent research has suggested that cognitive remediation exercises during this early phase may speed up the return of cognitive functioning and in so doing may have a direct effect on whether patients find the treatment useful and complete their treatment. By keeping patients in treatment longer, cognitive remediation may have an indirect effect on substance abuse outcomes. Objectives: To pilot test the introduction of cognitive remediation at the Substance Abuse Day Treatment Program (SADP) at the Errara Community Care Center. Aims are 1) to assess the receptivity of patients to the intervention by determining rates of agreement to participate, 2) to determine the number of cognitive remediation sessions that patients are willing to engage in, 3) to assess a variety of cognitive remediation tasks for their acceptability, 4) to evaluate neuropsychological improvements using pre-post assessment, 5) to evaluate its effects on substance abuse treatment participation, and 6) to evaluate its effects on substance abuse outcomes at 6 months follow-up. Design: Randomized clinical trial of cognitive remediation with an active control condition with observations at baseline, end of treatment and 6-months from intake
Study Type ICMJE	Interventional
Study Phase	Not Applicable
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Substance-Related Disorders
Intervention ICMJE	Behavioral: Cognitive Remediation; PSS Cogrehab
Study Arms	Experimental: 1 PSS CogRehab exercises Intervention: Behavioral: Cognitive Remediation; No Intervention: 2 On-line computer games
Publications *	Horner MD, Harvey RT, Denier CA. Self-report and objective measures of cognitive deficit in patients entering substance abuse treatment. Psychiatry Res. 1999 May 31;86(2):155-61.; Teichner G, Horner MD, Roitzsch JC, Herron J, Thevos A. Substance abuse treatment outcomes for cognitively impaired and intact outpatients. Addict Behav. 2002 Sep-Oct;27(5):751-63.; Grohman K, Fals-Stewart W. The detection of cognitive impairment among substance-abusing patients: the accuracy of the neuropsychological assessment battery-screening module. Exp Clin Psychopharmacol. 2004 Aug;12(3):200-7.; O'Malley S, Adamse M, Heaton RK, Gawin FH. Neuropsychological impairment in chronic cocaine abusers. Am J Drug Alcohol Abuse. 1992;18(2):131-44.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Terminated
Estimated Enrollment ICMJE; (submitted: June 2, 2006)	40
Original Enrollment ICMJE	Same as current
Actual Study Completion Date	December 2008
Actual Primary Completion Date	August 2007 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Inclusion Criteria: Veterans participating in a substance abuse day treatment program at the Errara Community Center Exclusion Criteria:
Sex/Gender	Sexes Eligible for Study: All
Ages	Child, Adult, Older Adult
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00334217
Other Study ID Numbers ICMJE	O3108R
Has Data Monitoring Committee	Not Provided
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Bell, Morris - Principal Investigator, Department of Veterans Affairs
Study Sponsor ICMJE	VA Office of Research and Development
Collaborators ICMJE	Not Provided
Investigators ICMJE	Principal Investigator: Morris D Bell, PhD VA Connecticut Health Care System (West Haven)
PRS Account	VA Office of Research and Development
Verification Date	June 2009
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP