Clinical trial NCT01410110: Cognitive Remediation and Work Therapy in the Initial Phase of Substance Abuse Treatment
Official title: Cognitive Remediation and Work Therapy in the Initial Phase of Substance Abuse Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Substance Abuse
Substance Dependence
Cognitive Impairment
Keywords: Substance Abuse
Substance Dependence
Cognitive Impairment
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2011-08-04
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Days of Sobriety in First 90 Days
timeFrame: 3 months
measure: Days of Use in Prior 30 Days
timeFrame: 30 Days Prior to 6 month follow-up
measure: Weeks of Sobriety
timeFrame: 26 weeks
Secondary outcomes:
measure: Attention Index
timeFrame: Baseline, 3 month and 6 month follow-up
measure: Processing Speed Index
timeFrame: Baseline, 3 Months, 6 Months
measure: Verbal and Visual Learning and Memory
timeFrame: Baseline, 3 Months, 6 Months
measure: Verbal and Visual Working Memory
timeFrame: Baseline, 3 Month, 6 Months
measure: Executive Function
timeFrame: Baseline, 3 Months, 6 Months
measure: Global Index
timeFrame: Baseline, 3 Months, 6 Months
Other outcomes:
Locations:
city: West Haven
country: United States
facility: VA Connecticut Healthcare System
state: Connecticut
Study officials:
affiliation: Yale University School of Medicine and VACHS
name: Morris D Bell, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.