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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Morris D. Bell, Yale University
ClinicalTrials.gov Identifier:
NCT01410110
First received: August 2, 2011
Last updated: January 14, 2015
Last verified: December 2014
  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:
  • Days of Sobriety in First 90 Days [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Abstinence will be determined by toxicology screening, breathalyzer and substance abuse calendar weekly during 3 months of active intervention. Days of sobriety has a range of 0 to 90 with higher being a better outcome.

  • Days of Use in Prior 30 Days [ Time Frame: 30 Days Prior to 6 month follow-up ] [ Designated as safety issue: No ]
    Days of Use based on Time-Line Follow-back, Toxicology Screen, Breathalyzer, and Chart Review. The range at 6 month follow-up is 0 to 30 days of use with more days being a worse outcome.

  • Weeks of Sobriety [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
    0 to 26 Weeks. Higher number of Weeks is better.


Secondary Outcome Measures:
  • Attention Index [ Time Frame: Baseline, 3 month and 6 month follow-up ] [ Designated as safety issue: No ]
    Index comprised on Trails A and Continuous Performance Test. T scores for the assessments are averaged. T scores range from 30 to 80 with a mean of 50. Higher scores are better.

  • Processing Speed Index [ Time Frame: Baseline, 3 Months, 6 Months ] [ Designated as safety issue: No ]
    Wechsler Adult Intelligence Scale (WAIS) Digit Coding and Symbol Search. T scores for the assessments are averaged. T scores range from 30 to 80 with a mean of 50. Higher scores are better.

  • Verbal and Visual Learning and Memory [ Time Frame: Baseline, 3 Months, 6 Months ] [ Designated as safety issue: No ]
    Brief Visual-Spatial Memory Test (BVMT) and Hopkins Verbal Learning and Memory Test (HVLT). Total Score T Scores for tests were averaged. T score range is 30 to 80 with a mean of 50. Higher scores are better.

  • Verbal and Visual Working Memory [ Time Frame: Baseline, 3 Month, 6 Months ] [ Designated as safety issue: No ]
    WAIS Digit Span and Wechsler Memory Scale (WMS) Spatial Span. T Scores are averaged. T Scores range from 30 to 80 with a mean of 50. Higher scores are better.

  • Executive Function [ Time Frame: Baseline, 3 Months, 6 Months ] [ Designated as safety issue: No ]
    Mazes, Wisconsin Card Sorting Task (WCST) Perseverative Error, Non-Perseverative Error, Conceptual Level. T Scores for each variable were averaged together. T Scores have a range of 30 to 80 with a mean of 50. Higher scores are better.

  • Global Index [ Time Frame: Baseline, 3 Months, 6 Months ] [ Designated as safety issue: No ]
    Comprised of the average of 5 Index T Scores (Attention, Processing Speed, Visual and Verbal Memory and Learning, Working Memory and Executive Function). T Scores range from 30 to 80 with a mean of 50. Higher scores are better.


Enrollment: 48
Study Start Date: December 2010
Study Completion Date: December 2014
Primary Completion Date: December 2014 (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 (Days of Use) for a future R01 RCT submission. 3. Obtain effect sizes for secondary outcomes (e.g. neurocognition).

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

Locations
United States, Connecticut
VA Connecticut Healthcare System
West Haven, Connecticut, United States, 06516
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 D. Bell, Professor, Yale University
ClinicalTrials.gov Identifier: NCT01410110     History of Changes
Other Study ID Numbers: 1011007601, R21DA030744-02
Study First Received: August 2, 2011
Results First Received: December 15, 2014
Last Updated: January 14, 2015
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 June 28, 2015