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Cognitive Training in the Treatment of AUD

Primary Purpose

Alcohol Use Disorder Cognitive Decline

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Remediation Training
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Use Disorder Cognitive Decline focused on measuring AUD, Neuropsychology, Cognitive Remediation

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • VA Connecticut Healthcare System West Haven Campus, West Haven, CT

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CRT+IDC

Computer Game Play+IDC

Arm Description

Cognitive Remediation Therapy for 13 weeks plus Individual Drug Counseling

Computer arcade games for 13 weeks plus Individual Drug Counseling

Outcomes

Primary Outcome Measures

Alcohol and other drug use assessed by weekly Time Line Follow-back and breathalyzer
Heavy Drinking Days and Days of use over 90 days

Secondary Outcome Measures

Alcohol and other drug use assessed by weekly Time Line Follow-back and breathalyzer
Heavy Drinking Days and Days of use over 30 days
Penn Alcohol Craving Scale
Changes in self-ratings of alcohol craving from baseline.
Neurocognitive assessments using neurocognitive tests of attention, processing speed, executive function and memory
Changes from baseline on neurocognitive domains of attention, processing speed, executive function, working memory and learning and memory.

Full Information

First Posted
January 14, 2016
Last Updated
July 18, 2022
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT02664038
Brief Title
Cognitive Training in the Treatment of AUD
Official Title
Cognitive Training in the Treatment of Alcohol Use Disorders in Older Veterans
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
August 22, 2016 (Actual)
Primary Completion Date
September 30, 2021 (Actual)
Study Completion Date
June 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use Disorder Cognitive Decline
Keywords
AUD, Neuropsychology, Cognitive Remediation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CRT+IDC
Arm Type
Experimental
Arm Description
Cognitive Remediation Therapy for 13 weeks plus Individual Drug Counseling
Arm Title
Computer Game Play+IDC
Arm Type
Active Comparator
Arm Description
Computer arcade games for 13 weeks plus Individual Drug Counseling
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Remediation Training
Intervention Description
Up to 65 hours of computer based cognitive training of attention, verbal and visual memory, verbal and visual working memory, and executive functions
Primary Outcome Measure Information:
Title
Alcohol and other drug use assessed by weekly Time Line Follow-back and breathalyzer
Description
Heavy Drinking Days and Days of use over 90 days
Time Frame
3 months of active treatment
Secondary Outcome Measure Information:
Title
Alcohol and other drug use assessed by weekly Time Line Follow-back and breathalyzer
Description
Heavy Drinking Days and Days of use over 30 days
Time Frame
30 days preceding 6 month follow-up, 3 months after active treatment.
Title
Penn Alcohol Craving Scale
Description
Changes in self-ratings of alcohol craving from baseline.
Time Frame
3 months of active treatment and 6 month follow-up
Title
Neurocognitive assessments using neurocognitive tests of attention, processing speed, executive function and memory
Description
Changes from baseline on neurocognitive domains of attention, processing speed, executive function, working memory and learning and memory.
Time Frame
7 weeks, 3 month and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Morris D. Bell, PhD
Organizational Affiliation
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
City
West Haven
State/Province
Connecticut
ZIP/Postal Code
06516
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Cognitive Training in the Treatment of AUD

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