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| ID | Type | Description | Link |
|---|---|---|---|
| R21DA030744-02 | U.S. NIH Grant/Contract | View source |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cognitive Training + Work Therapy | Experimental | 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. |
|
| Work Therapy Only | Active Comparator | Same work therapy but for 20 hours per week. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Training + Work Therapy | Behavioral | Cognitive training for 5 hours per week for 13 weeks and 15 hours of work therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Processing Speed Index |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Morris D Bell, Ph.D. | Yale University School of Medicine and VACHS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Connecticut Healthcare System | West Haven | Connecticut | 06516 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27732034 | Derived | 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. | |
| 26828571 | Derived | 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. |
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Following informed consent, participants completed baseline assessments and their VA medical record was reviewed to determine whether they met inclusion/exclusion criteria.
Recruitment was by referral from clinicians at VA Substance Abuse program including a 21 day substance abuse day program and a 30 day residential program. Recruitment began in January 2011 and was completed in March 2014.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cognitive Training + Work Therapy | 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. Cognitive Training + Work Therapy: Cognitive training for 5 hours per week for 13 weeks and 15 hours of work therapy |
| FG001 | Work Therapy Only | Same work therapy but for 20 hours per week. Work Therapy: 20 hours per week of work therapy |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Cognitive Training + Work Therapy | 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. Cognitive Training + Work Therapy: Cognitive training for 5 hours per week for 13 weeks and 15 hours of work therapy |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | Days of Sobriety | 3 months |
|
Entire length of study
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cognitive Training + Work Therapy | 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. Cognitive Training + Work Therapy: Cognitive training for 5 hours per week for 13 weeks and 15 hours of work therapy |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Morris Bell, Ph.D. | Yale University School of Medicine | 203-932-5711 | 2281 | morris.bell@yale.edu |
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| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
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| ID | Term |
|---|---|
| D000091942 | Cognitive Training |
| ID | Term |
|---|---|
| D000066530 | Neurological Rehabilitation |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
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| Work Therapy | Behavioral | 20 hours per week of work therapy |
|
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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 26684868 | Derived | 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. |
| BG001 | Work Therapy Only | Same work therapy but for 20 hours per week. Work Therapy: 20 hours per week of work therapy |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Marital Status | Number | participants |
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| Axis 1 Primary Diagnosis | Number | participants |
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| Education | Mean | Standard Deviation | years |
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| Felony Convictions | Number | participants |
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| Disability (SSDI or VA Service Connected) | Number | participants |
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| Global Assessment of Function (GAF) | The Global Assessment of Function Scale range is from 1 to 100. Higher scores indicate better functioning. | Mean | Standard Deviation | units on a scale |
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Same work therapy but for 20 hours per week. Work Therapy: 20 hours per week of work therapy |
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|
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| 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. | Posted | Mean | Standard Deviation | T Scores | Baseline, 3 month and 6 month follow-up |
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| 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. | Posted | Mean | Standard Deviation | Days of Use | 30 Days Prior to 6 month follow-up |
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| Primary | Weeks of Sobriety | 0 to 26 Weeks. Higher number of Weeks is better. | 1 additional participant in Work Therapy Only had missing data for this variable. | Posted | Mean | Standard Deviation | Weeks | 26 weeks |
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| 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. | Posted | Mean | Standard Deviation | T Scores | Baseline, 3 Months, 6 Months |
|
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| 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. | Posted | Mean | Standard Deviation | T Scores | Baseline, 3 Months, 6 Months |
|
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| 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. | Posted | Mean | Standard Deviation | T Scores | Baseline, 3 Month, 6 Months |
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| 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. | Posted | Mean | Standard Deviation | T Scores | Baseline, 3 Months, 6 Months |
|
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| 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. | Posted | Mean | Standard Deviation | T Scores | Baseline, 3 Months, 6 Months |
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| 0 |
| 24 |
| 0 |
| 24 |
| EG001 | Work Therapy Only | Same work therapy but for 20 hours per week. Work Therapy: 20 hours per week of work therapy | 0 | 24 | 0 | 24 |
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| D005791 |
| Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| 6 Month |
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| 6 Months |
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| 6 Months |
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| 6 Month |
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| 6 Month |
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| 6 Months |
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