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Cognitive Remediation and Work Therapy in the Initial Phase of Substance Abuse Treatment

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by Yale University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Yale University
ClinicalTrials.gov Identifier:
NCT01410110
First received: August 2, 2011
Last updated: August 3, 2011
Last verified: August 2011
  Purpose

The initial phase of substance abuse treatment is a vulnerable period for relapse. Cognitive impairments are common during this phase and may reduce the ability to benefit from other forms of substance abuse and rehabilitation services. The study compares a rehabilitation program that combines work therapy with computer-based cognitive training of attention, memory and executive functions to work therapy alone in a 3 months outpatient substance abuse program. It is hypothesized that cognitive training will increase days of sobriety during the active intervention and better substance abuse outcomes at 6 month follow-up.


Condition Intervention Phase
Substance Abuse
Substance Dependence
Cognitive Impairment
Behavioral: Cognitive Training + Work Therapy
Behavioral: Work Therapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cognitive Remediation and Work Therapy in the Initial Phase of Substance Abuse Treatment

Further study details as provided by Yale University:

Primary Outcome Measures:
  • Percent Days of Abstinence [ Time Frame: 3 months and 6 months ] [ Designated as safety issue: No ]
    Abstinence will be determined by toxicology screening, breathalizer and substance abuse calendar weekly during 3 months of active intervention. At 6 month follow-up, relapse will be determined by substance abuse calendar and clinical record review.


Secondary Outcome Measures:
  • Cognitive functioning and symptoms [ Time Frame: Baseline, 3 month and 6 month follow-up ] [ Designated as safety issue: No ]
    Neurocognitive assessments will measure attention, memory, executive function and impulsivity. Symptoms will be measured with the Brief Symptom Inventory


Estimated Enrollment: 50
Study Start Date: December 2010
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cognitive Training + Work Therapy

Cognitive Training using auditory and visual Positscience software 5 hours/per week for 13 weeks.

Work Therapy for 15 hours per week at half minimum wage doing entry level duties at medical center job sites, supervised by regular medical center staff.

Behavioral: Cognitive Training + Work Therapy
Cognitive training for 5 hours per week for 13 weeks and 15 hours of work therapy
Active Comparator: Work Therapy Only
Same work therapy but for 20 hours per week.
Behavioral: Work Therapy
20 hours per week of work therapy

Detailed Description:

This proposal aims to pilot test a cognitive remediation therapy (CRT) combined with work therapy (WT) as an adjunct to the initial phase of outpatient substance abuse treatment. There is ample research evidence of cognitive impairment across substance abuse disorders, particularly in the early phase of recovery. Cognitive impairment has been associated with poorer substance abuse treatment outcomes and may be remediated through programs of exercises that target these impairments. The investigators have previously reported on a model of providing CRT with work therapy (WT) in an outpatient context for people with psychotic disorders, which showed significant improvements in executive function and working memory, and in important functional outcomes such as work performance and sustained work activity. The investigators propose to apply this same approach to a sample of participants recruited from a 30-day residential program for substance abusers who are beginning their recovery. When they are discharged, they will be able to continue WT, which may encourage their engagement in CRT and in substance abuse outpatient services.

Our Specific Aims are: 1. Test the feasibility and tolerability of CRT & WT in the early phase of substance abuse treatment. 2. Obtain effect size for CRT & WT compared to WT alone on a primary substance abuse outcome measure (Percent Days of Abstinence, PDA) for a future R01 RCT submission. 3. Obtain effect sizes for secondary outcomes (cognitive, psychosocial, vocational). 3. Examine effects of moderators such as age, type of substance abuse, and cognitive functioning that may be relevant for determining inclusion/exclusion criteria for an RCT. 4. Examine mediators of outcome such as neuropsychological change and treatment adherence to understand the mechanisms of treatment effects.

The investigators propose to accomplish these aims by randomizing 50 participants who wish to receive WT services into two conditions: 25 will be assigned to 15 hours of WT plus 5 hours of CRT each week (CRT+WT) and 25 will be assigned to an active control of 20 hours of WT. The active intervention will be for 13 weeks. CRT will be comprised of a repetitive training on a hierarchy of progressive visual and auditory exercise from Positscience. WT will involve paid work activity in a placement of their choosing on the medical center campus. Participants will be paid the same hourly rate (half federal minimum wage) for their time in CRT and WT. Comprehensive assessments will be performed at intake, 3 months and 6 months. These will include substance abuse, cognitive, and psychosocial outcomes as well as adherence to treatment. During the 3 months of active intervention participants will have weekly observed urine toxicology screens, breathalyzer tests and PDA assessments, as well as monthly work performance evaluations. Data analyses will include random effects regression models, as well as models of moderator and mediator effects on the primary outcome of PDA. If meaningful effects are found, these results will guide a subsequent R01 submission.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • In the initial phase of treatment for substance abuse or dependence at VACHS.
  • Fluency in English 6th grade or higher reading level DSM-IV criteria for any current drug use disorder
  • Willingness to attend follow-up assessments at 13 and 26 weeks
  • Willingness to submit to observed urine toxicology and breathalyzer screenings

Exclusion Criteria:

  • Untreated psychotic disorder
  • Current prescribed treatment of opioids or benzodiazepines
  • Having a legal case that may lead to incarceration during study period
  • Residential plans that would interfere with participation
  • Developmental disability or medical illness that may significantly compromise cognition or prevent work activity
  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: NCT01410110

Contacts
Contact: Lukasz Krol, Psy.D. 203 932-5711 ext 2225 lukasz.krol@yale.edu
Contact: Andrea Weinstein, MA 203 932-5711 ext 4155 andrea.weinstein@yale.edu

Locations
United States, Connecticut
VA Connecticut Healthcare System Recruiting
West Haven, Connecticut, United States, 06516
Contact: Lukasz Krol, Psy.D.    203-932-5711 ext 2225    lukasz.krol@yale.edu   
Contact: Andrea Weinstein, MA    203 932-5711 ext 4155    andrea.weinstein@yale.edu   
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Morris D Bell, Ph.D. Yale University School of Medicine and VACHS
  More Information

No publications provided

Responsible Party: Morris David Bell, Ph.D., Yale University School of Medicine & VA Connecticut Healthcare Service
ClinicalTrials.gov Identifier: NCT01410110     History of Changes
Other Study ID Numbers: 1011007601, R21DA030744-02
Study First Received: August 2, 2011
Last Updated: August 3, 2011
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by Yale University:
Substance Abuse
Substance Dependence
Cognitive Impairment

Additional relevant MeSH terms:
Cognition Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on November 20, 2014