Cognitive Remediation in Early Substance Abuse Treatment | NCT00334217

Studies
Cognitive Remediation in Early Substance Abuse Treatment

NCT00334217

Sponsor

US Department of Veterans Affairs

Status

Terminated

Last Update Posted

Jun 18, 2009Estimated

Enrollment

40Estimated

Phase

Not Applicable

Conditions

Substance-Related Disorders

Interventions

Cognitive Remediation

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2009

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

The intervention could not be successfully carried out in the SADP setting because of issues independent of the cognitive training intervention.

Expanded Access Info

Start Date

Aug 2005

Primary Completion Date

Aug 2007Actual

Completion Date

Dec 2008Actual

First Submitted Date

Jun 2, 2006

First Submission Date that Met QC Criteria

Jun 2, 2006

First Posted Date

Jun 6, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 17, 2009

Last Update Posted Date

Jun 18, 2009Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

US Department of Veterans AffairsFED

Collaborators

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	PSS CogRehab exercises	Behavioral: Cognitive Remediation
2	No Intervention	On-line computer games

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cognitive Remediation	Behavioral	PSS Cogrehab	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cognitive improvement and adherence to substance abuse treatment		6 month follow-up

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Veterans participating in a substance abuse day treatment program at the Errara Community Center

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Morris D Bell, PhD	VA Connecticut Health Care System (West Haven)	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
VA Connecticut Health Care System (West Haven)		West Haven	Connecticut	06516	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
10397417	Result	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. doi: 10.1016/s0165-1781(99)00031-1.
12201382	Result	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. doi: 10.1016/s0306-4603(01)00207-6.

ID	Term
D064419	Chemically-Induced Disorders
D001523	Mental Disorders

ID	Term
D001521	Behavior Therapy
D011613	Psychotherapy
D004191	Behavioral Disciplines and Activities