Cognitive Remediation and Work Therapy in the Initial Phase of Substance Abuse Treatment
2 other identifiers
interventional
48
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Dec 2010
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2010
CompletedFirst Submitted
Initial submission to the registry
August 2, 2011
CompletedFirst Posted
Study publicly available on registry
August 4, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedResults Posted
Study results publicly available
January 19, 2015
CompletedJanuary 19, 2015
December 1, 2014
4 years
August 2, 2011
December 15, 2014
January 14, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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
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
Weeks of Sobriety
0 to 26 Weeks. Higher number of Weeks is better.
26 weeks
Secondary Outcomes (6)
Attention Index
Baseline, 3 month and 6 month follow-up
Processing Speed Index
Baseline, 3 Months, 6 Months
Verbal and Visual Learning and Memory
Baseline, 3 Months, 6 Months
Verbal and Visual Working Memory
Baseline, 3 Month, 6 Months
Executive Function
Baseline, 3 Months, 6 Months
- +1 more secondary outcomes
Study Arms (2)
Cognitive Training + Work Therapy
EXPERIMENTALCognitive 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.
Work Therapy Only
ACTIVE COMPARATORSame work therapy but for 20 hours per week.
Interventions
Cognitive training for 5 hours per week for 13 weeks and 15 hours of work therapy
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Yale Universitylead
Study Sites (1)
VA Connecticut Healthcare System
West Haven, Connecticut, 06516, United States
Related Publications (3)
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.
PMID: 27732034DERIVEDBell 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.
PMID: 26828571DERIVEDBell 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.
PMID: 26684868DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Use of WT limited recruitment to only those willing to participate in a work program for 13 weeks, reducing generalizability. WT may have powerful effects on sobriety that obscured benefits of CRT. As a pilot, this study was not adequately powered.
Results Point of Contact
- Title
- Morris Bell, Ph.D.
- Organization
- Yale University School of Medicine
Study Officials
- PRINCIPAL INVESTIGATOR
Morris D Bell, Ph.D.
Yale University School of Medicine and VACHS
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
August 2, 2011
First Posted
August 4, 2011
Study Start
December 1, 2010
Primary Completion
December 1, 2014
Study Completion
December 1, 2014
Last Updated
January 19, 2015
Results First Posted
January 19, 2015
Record last verified: 2014-12