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

• ClinicalTrials.gov Identifier: NCT01410110
• Recruitment Status: Completed
• First Posted: August 4, 2011
• Results First Posted: January 19, 2015
• Last Update Posted: January 19, 2015
• Sponsor: Yale University
• Information provided by (Responsible Party): Morris D. Bell, Yale University

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Substance Abuse; Substance Dependence; Cognitive Impairment	Behavioral: Cognitive Training + Work Therapy; Behavioral: Work Therapy	Phase 2

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 48 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Cognitive Remediation and Work Therapy in the Initial Phase of Substance Abuse Treatment
• Study Start Date: December 2010
• Actual Primary Completion Date: December 2014
• Actual Study Completion Date: December 2014

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. Days of Sobriety in First 90 Days [ Time Frame: 3 months ]
   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.
2. Days of Use in Prior 30 Days [ Time Frame: 30 Days Prior to 6 month follow-up ]
   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.
3. Weeks of Sobriety [ Time Frame: 26 weeks ]
   0 to 26 Weeks. Higher number of Weeks is better.

Secondary Outcome Measures :

1. Attention Index [ Time Frame: Baseline, 3 month and 6 month follow-up ]
   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.
2. Processing Speed Index [ Time Frame: Baseline, 3 Months, 6 Months ]
   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.
3. Verbal and Visual Learning and Memory [ Time Frame: Baseline, 3 Months, 6 Months ]
   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.
4. Verbal and Visual Working Memory [ Time Frame: Baseline, 3 Month, 6 Months ]
   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.
5. Executive Function [ Time Frame: Baseline, 3 Months, 6 Months ]
   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.
6. Global Index [ Time Frame: Baseline, 3 Months, 6 Months ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Bell MD, Laws HB, Petrakis IB. A randomized controlled trial of cognitive remediation and work therapy in the early phase of substance use disorder recovery for older veterans: Neurocognitive and substance use outcomes. Psychiatr Rehabil J. 2017 Mar;40(1):94-102. doi: 10.1037/prj0000211. Epub 2016 Oct 10.

Bell MD, Vissicchio NA, Weinstein AJ. Cognitive Training and Work Therapy for the Treatment of Verbal Learning and Memory Deficits in Veterans With Alcohol Use Disorders. J Dual Diagn. 2016;12(1):83-9. doi: 10.1080/15504263.2016.1145779.

Bell MD, Vissicchio NA, Weinstein AJ. Visual and verbal learning deficits in Veterans with alcohol and substance use disorders. Drug Alcohol Depend. 2016 Feb 1;159:61-5. doi: 10.1016/j.drugalcdep.2015.11.007. Epub 2015 Dec 2.

• Responsible Party: Morris D. Bell, Professor, Yale University
• ClinicalTrials.gov Identifier: NCT01410110
• Other Study ID Numbers: 1011007601; R21DA030744-02 ( U.S. NIH Grant/Contract )
• First Posted: August 4, 2011
• Results First Posted: January 19, 2015
• Last Update Posted: January 19, 2015
• Last Verified: December 2014

Keywords provided by Morris D. Bell, Yale University:

Substance Abuse; Substance Dependence; Cognitive Impairment

Additional relevant MeSH terms:

Substance-Related Disorders; Cognitive Dysfunction; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Chemically-Induced Disorders