Substance AbusePhase 2NCT01410110
Cognitive Remediation and Work Therapy in the Initial Phase of Substance Abuse Treatment
A Phase 2 study testing Cognitive Training + Work Therapy and Work Therapy in people with Substance Abuse and Substance Dependence, run by Yale University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Substance Abuse, Substance Dependence, Cognitive Impairment
- What is being tested?
- Cognitive Training + Work Therapy and Work Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2010to Dec 2014
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Connecticut Healthcare System
West Haven, Connecticut, 06516
About this study
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.
Read the 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.
- Conditions
- Substance Abuse, Substance Dependence, Cognitive Impairment
- Being tested
- Cognitive Training + Work Therapy, Work Therapy
- Keywords
- Substance Abuse, Substance Dependence, Cognitive Impairment
- Medical subject headings
- Substance-Related Disorders, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Training + Work TherapyBehavioural
Cognitive training for 5 hours per week for 13 weeks and 15 hours of work therapy
Work TherapyBehavioural
20 hours per week of work therapy
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Cognitive Training + Work Therapy |
| Work Therapy Only | Active comparator | Same work therapy but for 20 hours per week. Receives: Behavioral: Work Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 30 Days Prior to 6 month follow-up
Weeks of Sobriety
0 to 26 Weeks. Higher number of Weeks is better.
Measured: 26 weeks
Secondary outcomes (6)
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.
Measured: Baseline, 3 month and 6 month follow-up
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 3 Months, 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2011 (estimated)
- Study startDec 2010
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Substance AbuseStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Morris D. Bell, Yale University
- Investigators
- Morris D Bell, Ph.D., Principal investigator, Yale University School of Medicine and VACHS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01410110
- Sponsor's protocol ID
- 1011007601
- Other IDs
- R21DA030744-02
- Status last verified
- Dec 2014
- First submitted
- 2 Aug 2011
- Last updated
- 19 Jan 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 27732034Bell 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.
PubMed 26828571Bell 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.
PubMed 26684868
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Remediation and Work Therapy in the Initial Phase of Substance Abuse Treatment
- ClinicalTrials.gov ID
- NCT01410110
- Acronym / sponsor ID
- 1011007601
- Conditions
- Substance Abuse, Substance Dependence, Cognitive Impairment
- Keywords
- Substance Abuse, Substance Dependence, Cognitive Impairment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 4 Aug 2011 (estimated)
- Results
- Posted 19 Jan 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive Training + Work Therapy | Experimental | Behavioral: Cognitive Training + Work TherapyCognitive 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 | Behavioral: Work TherapySame work therapy but for 20 hours per week. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Training + Work TherapyCognitive training for 5 hours per week for 13 weeks and 15 hours of work therapy | Behavioural | Cognitive Training + Work Therapy |
| Work Therapy20 hours per week of work therapy | Behavioural | Work Therapy Only |
Primary outcome
Days of Sobriety in First 90 Days
Time frame: 3 months
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
Time frame: 30 Days Prior to 6 month follow-up
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
Time frame: 26 weeks
0 to 26 Weeks. Higher number of Weeks is better.
6 secondary outcomes
Attention Index
Time frame: Baseline, 3 month and 6 month follow-up
Processing Speed Index
Time frame: Baseline, 3 Months, 6 Months
Verbal and Visual Learning and Memory
Time frame: Baseline, 3 Months, 6 Months
Verbal and Visual Working Memory
Time frame: Baseline, 3 Month, 6 Months
Executive Function
Time frame: Baseline, 3 Months, 6 Months
Global Index
Time frame: Baseline, 3 Months, 6 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27732034Bell 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.
- Derived from this study: PubMed 26828571Bell 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.
- Derived from this study: PubMed 26684868Bell 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Morris D Bell, Ph.D. principal investigator
Yale University School of Medicine and VACHS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cognitive Training + Work Therapy and Work Therapy in people with Substance Abuse and Substance Dependence, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Jan 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Days of Sobriety in First 90 Days (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01410110, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2015.