search
Back to results

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

Primary Purpose

Substance Abuse, Substance Dependence, Cognitive Impairment

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Cognitive Training + Work Therapy
Work Therapy
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Substance Abuse focused on measuring Substance Abuse, Substance Dependence, Cognitive Impairment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • VA Connecticut Healthcare System

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cognitive Training + Work Therapy

Work Therapy Only

Arm Description

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.

Same work therapy but for 20 hours per week.

Outcomes

Primary Outcome Measures

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.
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.
Weeks of Sobriety
0 to 26 Weeks. Higher number of Weeks is better.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.

Full Information

First Posted
August 2, 2011
Last Updated
January 14, 2015
Sponsor
Yale University
search

1. Study Identification

Unique Protocol Identification Number
NCT01410110
Brief Title
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

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yale University

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Abuse, Substance Dependence, Cognitive Impairment
Keywords
Substance Abuse, Substance Dependence, Cognitive Impairment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cognitive Training + Work Therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Work Therapy Only
Arm Type
Active Comparator
Arm Description
Same work therapy but for 20 hours per week.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Training + Work Therapy
Intervention Description
Cognitive training for 5 hours per week for 13 weeks and 15 hours of work therapy
Intervention Type
Behavioral
Intervention Name(s)
Work Therapy
Intervention Description
20 hours per week of work therapy
Primary Outcome Measure Information:
Title
Days of Sobriety in First 90 Days
Description
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.
Time Frame
3 months
Title
Days of Use in Prior 30 Days
Description
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.
Time Frame
30 Days Prior to 6 month follow-up
Title
Weeks of Sobriety
Description
0 to 26 Weeks. Higher number of Weeks is better.
Time Frame
26 weeks
Secondary Outcome Measure Information:
Title
Attention Index
Description
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.
Time Frame
Baseline, 3 month and 6 month follow-up
Title
Processing Speed Index
Description
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.
Time Frame
Baseline, 3 Months, 6 Months
Title
Verbal and Visual Learning and Memory
Description
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.
Time Frame
Baseline, 3 Months, 6 Months
Title
Verbal and Visual Working Memory
Description
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.
Time Frame
Baseline, 3 Month, 6 Months
Title
Executive Function
Description
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.
Time Frame
Baseline, 3 Months, 6 Months
Title
Global Index
Description
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.
Time Frame
Baseline, 3 Months, 6 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Morris D Bell, Ph.D.
Organizational Affiliation
Yale University School of Medicine and VACHS
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Connecticut Healthcare System
City
West Haven
State/Province
Connecticut
ZIP/Postal Code
06516
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
27732034
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.
Results Reference
derived
PubMed Identifier
26828571
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.
Results Reference
derived
PubMed Identifier
26684868
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs