Cognitive Training in the Treatment of AUD

NCT02664038 | Completed Results

• 1 other identifier: D2017-R
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcohol Use Disorder Cognitive Decline

Keywords

AUD; Neuropsychology; Cognitive Remediation

Outcome Measures

Primary Outcomes (1)

• 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.

  3 months of active treatment

Secondary Outcomes (3)

• Days of Heavy Alcohol Use Assessed by Weekly Time Line Follow-back and Breathalyzer

  30 days preceding 6 month follow-up, 3 months after active treatment.

• Penn Alcohol Craving Scale

  6 month follow-up

• Neurocognitive Composite Score (Average of T-scores for Measures of Attention, Processing Speed, Memory, Delayed Recall, Executive Function)

  Baseline to 6 months

Study Arms (2)

CRT+IDC

EXPERIMENTAL

Cognitive Remediation Therapy for 13 weeks plus Individual Drug Counseling

Behavioral: Cognitive Remediation Training

Computer Game Play+IDC

ACTIVE COMPARATOR

Computer arcade games for 13 weeks plus Individual Drug Counseling

Behavioral: Cognitive Remediation Training

Interventions

Cognitive Remediation Training BEHAVIORAL

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

CRT+IDC; Computer Game Play+IDC

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

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

West Haven, Connecticut, 06516, United States

Location

Limitations and Caveats

Due to the pandemic, recruitment was below the 90 subjects proposed.

Results Point of Contact

• Title: Morris Bell, Ph.D., Senior Research Career Scientist
• Organization: VA Connecticut Healthcare System

morris.bell@va.gov

203-932-5711

Study Officials

• Morris D. Bell, PhD

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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2016
• First Posted: January 26, 2016
• Study Start: August 22, 2016
• Primary Completion: September 30, 2021
• Study Completion: June 30, 2022
• Last Updated: August 27, 2024
• Results First Posted: August 27, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)