Cognitive Training in the Treatment of AUD

NCT ID: NCT02664038

Last Updated: 2024-08-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 59 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-22
• Study Completion Date: 2022-06-30

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.

Conditions

Alcohol Use Disorder Cognitive Decline

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

CRT+IDC

Cognitive Remediation Therapy for 13 weeks plus Individual Drug Counseling

Group Type: EXPERIMENTAL

Cognitive Remediation Training

Intervention Type: BEHAVIORAL

Up to 65 hours of computer based cognitive training of attention, verbal and visual memory, verbal and visual working memory, and executive functions

Computer Game Play+IDC

Computer arcade games for 13 weeks plus Individual Drug Counseling

Group Type: ACTIVE_COMPARATOR

Cognitive Remediation Training

Intervention Type: BEHAVIORAL

Up to 65 hours of computer based cognitive training of attention, verbal and visual memory, verbal and visual working memory, and executive functions

Interventions

Cognitive Remediation Training

Up to 65 hours of computer based cognitive training of attention, verbal and visual memory, verbal and visual working memory, and executive functions

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Morris D. Bell, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

West Haven, Connecticut, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

D2017-R

Identifier Type: -

Identifier Source: org_study_id