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

Cognitive Impairment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01410110
• Other study ID #: 1011007601
• Secondary ID: R21DA030744-02
• Status: Completed
• Phase: Phase 2
• First received: August 2, 2011
• Last updated: January 14, 2015
• Start date: December 2010
• Est. completion date: December 2014

Study information

• Verified date: December 2014
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cognition Disorders
• Cognitive Impairment
• Substance Abuse
• Substance Dependence
• Substance-Related Disorders

Intervention

Behavioral:
• Cognitive Training + Work Therapy
Cognitive training for 5 hours per week for 13 weeks and 15 hours of work therapy
• Work Therapy
20 hours per week of work therapy

Locations

Country	Name	City	State
United States	VA Connecticut Healthcare System	West Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Days of Sobriety in First 90 Days	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.	3 months	No
Primary	Days of Use in Prior 30 Days	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.	30 Days Prior to 6 month follow-up	No
Primary	Weeks of Sobriety	0 to 26 Weeks. Higher number of Weeks is better.	26 weeks	No
Secondary	Attention Index	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.	Baseline, 3 month and 6 month follow-up	No
Secondary	Processing Speed Index	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.	Baseline, 3 Months, 6 Months	No
Secondary	Verbal and Visual Learning and Memory	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.	Baseline, 3 Months, 6 Months	No
Secondary	Verbal and Visual Working Memory	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.	Baseline, 3 Month, 6 Months	No
Secondary	Executive Function	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.	Baseline, 3 Months, 6 Months	No
Secondary	Global Index	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.	Baseline, 3 Months, 6 Months	No