Substance-Related DisordersNCT01633138
Performance-based Reinforcement to Enhance Cognitive Remediation Therapy
A study testing Cognitive Remediation Therapy - Standard and Cognitive Remediation Therapy plus Contingency Management in people with Substance-Related Disorders and Mental Disorders, run by Yale University at 1 site in United States.
Trial summary
The purpose of this study is to investigate whether monetary reinforcement for performance will enhance the effects of cognitive remediation therapy for substance users seeking treatment at an outpatient facility. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Substance-Related Disorders, Mental Disorders
- What is being tested?
- Cognitive Remediation Therapy - Standard and Cognitive Remediation Therapy plus Contingency Management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 18 to 60 years old
- Primary Alcohol and/or Cocaine Abuse/Dependence Diagnosis
- Abstinence from all drugs/alcohol for 30 days
- Mild cognitive impairment
- Sufficiently stable and plan to commit to 4 weeks of outpatient treatment
- Fluent in English and 6th grade reading ability
Who cannot join
- Severe cognitive impairment indicative of dementia
- Untreated bipolar or psychotic disorder
- Have current legal case pending such that incarceration during 4-week study is likely
Trial locations and contacts
1 site in 1 country.
United States1 site
Substance Abuse Treatment Unit
New Haven, Connecticut, 06511
About this study
Official title: Pilot Study of Performance-based Reinforcement to Enhance Cognitive Remediation Therapy for Substance Users
The purpose of this study is to investigate whether monetary reinforcement for performance will enhance the effects of cognitive remediation therapy for substance users seeking treatment at an outpatient facility.
Read the detailed description
Forty individuals seeking treatment for an alcohol or cocaine use disorder at the Substance Abuse Treatment Unit (SATU) will be randomized to receive cognitive remediation therapy with or without additional compensation based on performance. Participants will use the computerized cognitive remediation program (PSSCogRehab 2012) three times per week for four weeks. The primary outcome measure will be an improved performance on the computerized tasks, with secondary outcomes of changes in cognitive functioning (e.g., attention, concentration, memory) as measured by neuropsychological tests between baseline and post-treatment.
- Conditions
- Substance-Related Disorders, Mental Disorders
- Being tested
- Cognitive Remediation Therapy - Standard, Cognitive Remediation Therapy plus Contingency Management
- Keywords
- cognitive remediation therapy, substance abuse treatment
- Medical subject headings
- Substance-Related Disorders, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Remediation Therapy - StandardBehavioural
Computerized cognitive remediation therapy provided three times per week for four weeks
Cognitive Remediation Therapy plus Contingency ManagementBehavioural
Standard cognitive remediation therapy plus monetary incentives based on performance provided three times per week for four weeks.
| Study group | Role | What they receive |
|---|---|---|
| CRT-S | Active comparator | Cognitive Remediation Therapy - Standard Receives: Behavioral: Cognitive Remediation Therapy - Standard |
| CRT-CM | Experimental | Cognitive Remediation Therapy plus Contingency Management Receives: Behavioral: Cognitive Remediation Therapy plus Contingency Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in performance scores on computerized cognitive remediation tasks
Performance scores on various computerized cognitive remediation tasks will be measured repeatedly during the 4 week study. These scores include "time to completion", "number of errors", "number of words correctly recalled", and "percentage of task completed"
Measured: 4 weeks
Secondary outcomes (1)
Improved cognitive function on neuropsychological tests
Change in cognitive function between baseline and post-treatment will be measured by performance on neuropsychological tests, such as Trail Making Test A \& B, Wisconsin Card Sort Test, Digit Symbol Test from WAIS-IV, and the Continuous Performance Test-II (CPT-II).
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2012 (estimated)
- Study startSep 2012
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance-Related DisordersStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Brian D Kiluk, PhD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01633138
- Sponsor's protocol ID
- 1205010253
- Other IDs
- P50DA009241
- Status last verified
- Mar 2020
- First submitted
- 27 Jun 2012
- Last updated
- 9 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Performance-based Reinforcement to Enhance Cognitive Remediation Therapy for Substance Users
- ClinicalTrials.gov ID
- NCT01633138
- Acronym / sponsor ID
- 1205010253
- Conditions
- Substance-Related Disorders, Mental Disorders
- Keywords
- cognitive remediation therapy, substance abuse treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Sep 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 4 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate whether monetary reinforcement for performance will enhance the effects of cognitive remediation therapy for substance users seeking treatment at an outpatient facility.
Detailed description
Forty individuals seeking treatment for an alcohol or cocaine use disorder at the Substance Abuse Treatment Unit (SATU) will be randomized to receive cognitive remediation therapy with or without additional compensation based on performance. Participants will use the computerized cognitive remediation program (PSSCogRehab 2012) three times per week for four weeks. The primary outcome measure will be an improved performance on the computerized tasks, with secondary outcomes of changes in cognitive functioning (e.g., attention, concentration, memory) as measured by neuropsychological tests between baseline and post-treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CRT-S | Active comparator | Behavioral: Cognitive Remediation Therapy - StandardCognitive Remediation Therapy - Standard |
| CRT-CM | Experimental | Behavioral: Cognitive Remediation Therapy plus Contingency ManagementCognitive Remediation Therapy plus Contingency Management |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 18 to 60 years old
- Primary Alcohol and/or Cocaine Abuse/Dependence Diagnosis
- Abstinence from all drugs/alcohol for 30 days
- Mild cognitive impairment
- Sufficiently stable and plan to commit to 4 weeks of outpatient treatment
Key exclusion criteria (3 listed)
- Severe cognitive impairment indicative of dementia
- Untreated bipolar or psychotic disorder
- Have current legal case pending such that incarceration during 4-week study is likely
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 Remediation Therapy - StandardComputerized cognitive remediation therapy provided three times per week for four weeks | Behavioural | CRT-S |
| Cognitive Remediation Therapy plus Contingency ManagementStandard cognitive remediation therapy plus monetary incentives based on performance provided three times per week for four weeks. | Behavioural | CRT-CM |
Primary outcome
Improvement in performance scores on computerized cognitive remediation tasks
Time frame: 4 weeks
Performance scores on various computerized cognitive remediation tasks will be measured repeatedly during the 4 week study. These scores include "time to completion", "number of errors", "number of words correctly recalled", and "percentage of task completed"
1 secondary outcome
Improved cognitive function on neuropsychological tests
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2020.
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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.
Brian D Kiluk, PhD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Remediation Therapy - Standard and Cognitive Remediation Therapy plus Contingency Management in people with Substance-Related Disorders and Mental Disorders, 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 6 inclusion and 3 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 9 Mar 2020. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Improvement in performance scores on computerized cognitive remediation tasks (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Mar 2020.