West Haven, Connecticut 06516

  • Cognitive Impairment


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.

Study summary:

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.


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 Contact:

Principal Investigator
Morris D Bell, Ph.D.
Yale University School of Medicine and VACHS

Lukasz Krol, Psy.D.
Phone: 203 932-5711 ext. 2225
Email: lukasz.krol@yale.edu

Backup Contact:

Email: andrea.weinstein@yale.edu
Andrea Weinstein, MA
Phone: 203 932-5711 ext. 4155

Location Contact:

West Haven, Connecticut 06516
United States

Lukasz Krol, Psy.D.
Phone: 203-932-5711
Email: lukasz.krol@yale.edu

Site Status: Recruiting

Data Source: ClinicalTrials.gov

Date Processed: September 16, 2021

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