Cognitive Remediation in Early Substance Abuse Treatment
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ClinicalTrials.gov Identifier: NCT00334217 |
Recruitment Status
:
Terminated
(The intervention could not be successfully carried out in the SADP setting because of issues independent of the cognitive training intervention.)
First Posted
: June 6, 2006
Last Update Posted
: June 18, 2009
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Tracking Information | ||||
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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 |
Cognitive improvement and adherence to substance abuse treatment [ Time Frame: 6 month follow-up ] | |||
Original Primary Outcome Measures ICMJE |
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 |
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 |
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Study Type ICMJE | Interventional | |||
Study Phase | Not Applicable | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Substance-Related Disorders | |||
Intervention ICMJE | Behavioral: Cognitive Remediation
PSS Cogrehab |
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Study Arms |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Terminated | |||
Estimated Enrollment ICMJE |
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:
Exclusion Criteria: |
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Sex/Gender |
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Ages | Child, Adult, Senior | |||
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 |
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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 |