Alcohol Use Disorder Cognitive DeclineNCT02664038
Cognitive Training in the Treatment of AUD
A study testing Cognitive Remediation Training in people with Alcohol Use Disorder Cognitive Decline, run by VA Office of Research and Development at 1 site in United States.
Trial summary
Alcohol Use Disorders (AUDs) have a significant public health impact and are highly prevalent in Veterans. Alcohol related brain effects on neurocognition (attention, memory and executive function) reduce ability to benefit from current treatments. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Alcohol Use Disorder Cognitive Decline
- What is being tested?
- Cognitive Remediation Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Aug 2016to 30 Jun 2022
- Phase
- Interventional
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Veterans enrolled in VA AUD treatment as usual and Non-Veteran community members in AUD treatment
- Have a primary diagnosis of AUD and are within 30 days of detoxification or last use at time of recruitment
Who cannot join
- Other medical illnesses that compromise neurocognition
- Active use of prescribed opioids or benzodiazepines that may hinder new learning
- Commitment to complete active phase and attend follow-up
- No pending incarceration or plans to leave the state
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
West Haven, Connecticut, 06516
About this study
Official title: Cognitive Training in the Treatment of Alcohol Use Disorders in Older Veterans
Alcohol Use Disorders (AUDs) have a significant public health impact and are highly prevalent in Veterans. Alcohol related brain effects on neurocognition (attention, memory and executive function) reduce ability to benefit from current treatments. These cognitive impairments are especially common in the early phase of recovery, persist over years and get worse with age. Recent research suggests that cognitive remediation therapy (CRT) may improve attention, memory and executive function in other disorders, and the investigators just completed pilot study with AUD Veterans found significantly greater improvements for those receiving CRT. The proposed study examines AUD outcomes and neurocognitive improvements when CRT is combined with a standardized alcohol treatment. The investigators hypothesize that CRT will improve neurocognition and AUD outcomes more than standardized alcohol treatment alone. Findings will determine whether CRT augmentation can benefit Veterans with AUDs.
Read the detailed description
This study aims to determine whether a combined intervention of cognitive remediation therapy (CRT) and Individual Drug Counseling (IDC) can benefit older Veterans in the initial phase of alcohol abuse treatment by improving abstinence outcomes and neurocognition. Substantial cognitive impairment is associated with alcohol use disorders (AUD), and becomes worse with years of use and the aging processes. In particular, Veterans entering treatment for AUD display cognitive deficits that may reduce their ability to benefit from treatment. While there is considerable variety in the severity and types of cognitive impairment found in newly recovering patients, problems with attention, learning and memory and executive function are common. Since treatment requires that the individual be able to sustain attention, remember what is learned, and apply it to recovery, impaired underlying cognitive processes make successful treatment less likely. Moreover, problems with executive functioning and other pre-frontal cognitive processes have been associated with decreased treatment retention and poorer AUD treatment outcomes. Although cognition can improve with sustained abstinence, it is during the early phase of recovery, when cognition is most impaired, that patients receive the most intensive treatment. AUD is a major cause of suffering and functional disability for older Veterans and a common co-morbidity with other physical and mental disorders. Finding more effective treatments of AUD remains a priority for VA healthcare.
The purpose of the proposed study is to learn whether CRT plus IDC, an evidence-based outpatient AUD treatment is more effective than a Game-Play Placebo plus IDC. Game-Play Placebo has been used to provide equipoise between conditions in other CRT studies and in a current CRT study with mTBI Veterans funded by DoD being conducted by the PI. The current study is a randomized controlled trial (RCT) with a target enrollment of 90 Veterans in the initial phase of AUD treatment. The study is sufficiently powered to allow us to fulfill the following aims and test their related hypotheses:
Specific Primary Aim # 1: To determine if CRT+IDC is more effective than Game-Play Placebo +IDC in decreasing alcohol use in older Veterans during the 3 month active intervention period.
Ho1: CRT+IDC will be more effective than Game-Play Placebo+IDC in reducing heavy drinking days and decreasing days of use as measured by Breathalyzer and Timeline Follow-back Method (TLFB) during the 90 days of active intervention.
Secondary Aim #1: To determine if CRT+IDC is more effective than Game-Play Placebo+ IDC in sustaining decreased alcohol use in older Veterans at the end of 6 months (3 months after the active intervention period).
Ho2: CRT+IDC will be more effective than Game-Play Placebo+IDC in reducing heavy drinking days and decreasing days of use as measured by Breathalyzer and Timeline Follow-back Method (TLFB) for the 30 days preceding 6 month follow-up.
Secondary Aim #2: To determine if the combination of CRT and IDC is more effective than game play placebo and IDC in improving neurocognitive functioning.
Ho3: Veterans receiving CRT+IDC will show greater improvement than Veterans receiving Game-Play Placebo+IDC at 3 month follow-up on a global index of neurocognitive function, and on an index of working memory and an index of executive function.
Ho4: Differential improvements in neurocognitive function will be sustained at 6 month follow-up.
- Conditions
- Alcohol Use Disorder Cognitive Decline
- Being tested
- Cognitive Remediation Training
- Keywords
- AUD, Neuropsychology, Cognitive Remediation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Remediation TrainingBehavioural
Up to 65 hours of computer based cognitive training of attention, verbal and visual memory, verbal and visual working memory, and executive functions
| Study group | Role | What they receive |
|---|---|---|
| CRT+IDC | Experimental | Cognitive Remediation Therapy for 13 weeks plus Individual Drug Counseling Receives: Behavioral: Cognitive Remediation Training |
| Computer Game Play+IDC | Active comparator | Computer arcade games for 13 weeks plus Individual Drug Counseling Receives: Behavioral: Cognitive Remediation Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Days of Heavy Alcohol Use Assessed by Weekly Time Line Follow-back and Breathalyzer
Heavy alcohol use over 90 days as verified by Time Line Follow-back or breathalyzer findings. Minimum = 0. Maximum = 90. Fewer days is better.
Measured: 3 months of active treatment
Secondary outcomes (3)
Days of Heavy Alcohol Use Assessed by Weekly Time Line Follow-back and Breathalyzer
Days of heavy drinking days over 30 days adjusted for baseline 30 Day heavy drinking days prior to randomization. Minimum = 0. Maximum = 30. Fewer days is better.
Measured: 30 days preceding 6 month follow-up, 3 months after active treatment.
Penn Alcohol Craving Scale
Changes in self-ratings of alcohol craving from baseline to 6 months. Minimum score = 0. Maximum score = 30. Lower is better.
Measured: 6 month follow-up
Neurocognitive Composite Score (Average of T-scores for Measures of Attention, Processing Speed, Memory, Delayed Recall, Executive Function)
Changes from baseline on Neurocognitive Composite Score Minimum score = 30; Mean = 50 indicates the population mean with a standard deviation of 10; Maximum score = 70. Higher is better.
Measured: Baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2016 (estimated)
- Study start22 Aug 2016
- Primary completion30 Sep 2021
- Study completion30 Jun 2022
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.
- Other trials for Alcohol Use Disorder Cognitive DeclineStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Morris D. Bell, PhD, Principal investigator, VA Connecticut Healthcare System West Haven Campus, West Haven, CT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02664038
- Sponsor's protocol ID
- D2017-R
- Status last verified
- Aug 2024
- First submitted
- 14 Jan 2016
- Last updated
- 27 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Training in the Treatment of Alcohol Use Disorders in Older Veterans
- ClinicalTrials.gov ID
- NCT02664038
- Acronym / sponsor ID
- D2017-R
- Conditions
- Alcohol Use Disorder Cognitive Decline
- Keywords
- AUD, Neuropsychology, Cognitive Remediation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 22 Aug 2016 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 26 Jan 2016 (estimated)
- Results
- Posted 27 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Alcohol Use Disorders (AUDs) have a significant public health impact and are highly prevalent in Veterans. Alcohol related brain effects on neurocognition (attention, memory and executive function) reduce ability to benefit from current treatments. These cognitive impairments are especially common in the early phase of recovery, persist over years and get worse with age. Recent research suggests that cognitive remediation therapy (CRT) may improve attention, memory and executive function in other disorders, and the investigators just completed pilot study with AUD Veterans found significantly greater improvements for those receiving CRT. The proposed study examines AUD outcomes and neurocognitive improvements when CRT is combined with a standardized alcohol treatment. The investigators hypothesize that CRT will improve neurocognition and AUD outcomes more than standardized alcohol treatment alone. Findings will determine whether CRT augmentation can benefit Veterans with AUDs.
Detailed description
This study aims to determine whether a combined intervention of cognitive remediation therapy (CRT) and Individual Drug Counseling (IDC) can benefit older Veterans in the initial phase of alcohol abuse treatment by improving abstinence outcomes and neurocognition. Substantial cognitive impairment is associated with alcohol use disorders (AUD), and becomes worse with years of use and the aging processes. In particular, Veterans entering treatment for AUD display cognitive deficits that may reduce their ability to benefit from treatment. While there is considerable variety in the severity and types of cognitive impairment found in newly recovering patients, problems with attention, learning and memory and executive function are common. Since treatment requires that the individual be able to sustain attention, remember what is learned, and apply it to recovery, impaired underlying cognitive processes make successful treatment less likely. Moreover, problems with executive functioning and other pre-frontal cognitive processes have been associated with decreased treatment retention and poorer AUD treatment outcomes. Although cognition can improve with sustained abstinence, it is during the early phase of recovery, when cognition is most impaired, that patients receive the most intensive treatment. AUD is a major cause of suffering and functional disability for older Veterans and a common co-morbidity with other physical and mental disorders. Finding more effective treatments of AUD remains a priority for VA healthcare.
The purpose of the proposed study is to learn whether CRT plus IDC, an evidence-based outpatient AUD treatment is more effective than a Game-Play Placebo plus IDC. Game-Play Placebo has been used to provide equipoise between conditions in other CRT studies and in a current CRT study with mTBI Veterans funded by DoD being conducted by the PI. The current study is a randomized controlled trial (RCT) with a target enrollment of 90 Veterans in the initial phase of AUD treatment. The study is sufficiently powered to allow us to fulfill the following aims and test their related hypotheses:
Specific Primary Aim # 1: To determine if CRT+IDC is more effective than Game-Play Placebo +IDC in decreasing alcohol use in older Veterans during the 3 month active intervention period.
Ho1: CRT+IDC will be more effective than Game-Play Placebo+IDC in reducing heavy drinking days and decreasing days of use as measured by Breathalyzer and Timeline Follow-back Method (TLFB) during the 90 days of active intervention.
Secondary Aim #1: To determine if CRT+IDC is more effective than Game-Play Placebo+ IDC in sustaining decreased alcohol use in older Veterans at the end of 6 months (3 months after the active intervention period).
Ho2: CRT+IDC will be more effective than Game-Play Placebo+IDC in reducing heavy drinking days and decreasing days of use as measured by Breathalyzer and Timeline Follow-back Method (TLFB) for the 30 days preceding 6 month follow-up.
Secondary Aim #2: To determine if the combination of CRT and IDC is more effective than game play placebo and IDC in improving neurocognitive functioning.
Ho3: Veterans receiving CRT+IDC will show greater improvement than Veterans receiving Game-Play Placebo+IDC at 3 month follow-up on a global index of neurocognitive function, and on an index of working memory and an index of executive function.
Ho4: Differential improvements in neurocognitive function will be sustained at 6 month follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CRT+IDC | Experimental | Behavioral: Cognitive Remediation TrainingCognitive Remediation Therapy for 13 weeks plus Individual Drug Counseling |
| Computer Game Play+IDC | Active comparator | Behavioral: Cognitive Remediation TrainingComputer arcade games for 13 weeks plus Individual Drug Counseling |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Veterans enrolled in VA AUD treatment as usual and Non-Veteran community members in AUD treatment
- Have a primary diagnosis of AUD and are within 30 days of detoxification or last use at time of recruitment
Key exclusion criteria (4 listed)
- Other medical illnesses that compromise neurocognition
- Active use of prescribed opioids or benzodiazepines that may hinder new learning
- Commitment to complete active phase and attend follow-up
- No pending incarceration or plans to leave the state
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 TrainingUp to 65 hours of computer based cognitive training of attention, verbal and visual memory, verbal and visual working memory, and executive functions | Behavioural | CRT+IDC, Computer Game Play+IDC |
Primary outcome
Days of Heavy Alcohol Use Assessed by Weekly Time Line Follow-back and Breathalyzer
Time frame: 3 months of active treatment
Heavy alcohol use over 90 days as verified by Time Line Follow-back or breathalyzer findings. Minimum = 0. Maximum = 90. Fewer days is better.
3 secondary outcomes
Days of Heavy Alcohol Use Assessed by Weekly Time Line Follow-back and Breathalyzer
Time frame: 30 days preceding 6 month follow-up, 3 months after active treatment.
Penn Alcohol Craving Scale
Time frame: 6 month follow-up
Neurocognitive Composite Score (Average of T-scores for Measures of Attention, Processing Speed, Memory, Delayed Recall, Executive Function)
Time frame: Baseline to 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Alcohol Use Disorder Cognitive Decline
Active, not recruitingPhase 1
rTMS in Older Adults With MCI and AUD
Alcohol Use Disorder, Mild Cognitive Impairment
Active, not recruitingObservational study
Factors Predicting Outcome in Group Treatment of Alcohol Use Disorders (AUDs)
Alcohol Use Disorder (AUD), Alcohol Abuse
Active, not recruiting
NEUROPSYCHOLOGICAL REHABILITATION FOR ALCOHOL USE DISORDERS
Alcohol Use Disorder Cognitive Decline
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, PhD principal investigator
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
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 Training in people with Alcohol Use Disorder Cognitive Decline, run by VA Office of Research and Development 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 2 inclusion and 4 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 27 Aug 2024. 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?
Yes. Results are posted in the registry (first posted 27 Aug 2024). 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 Heavy Alcohol Use Assessed by Weekly Time Line Follow-back and Breathalyzer (time frame: 3 months of active treatment). 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 27 Aug 2024.