AAT for Alcohol Use Disorder in Veterans

NCT05372029 | Recruiting

• 1 other identifier: D3793-R
• Study Type: interventional
• Target: 176
• Locations: 1 country
• Sites: 1

Brief Summary

The proposed study will test a novel treatment for alcohol use disorders (AUD) to determine if it helps Veterans reduce their hazardous drinking and recover from alcohol-related functional impairments across social, occupational, and domestic domains. To do so, the investigators will evaluate clinical, cognitive, and neural effects of a computer-delivered Approach Avoidance Training (AAT) treatment - which changes implicit tendencies to approach alcohol-related cues - in conjunction with standard VA care. The project will support RR\&D's mission to improve Veterans' participation in their lives and community by determining if this innovative alternative technique can improve recovery outcomes for Veterans with AUD and exploring how the intervention works.

Conditions

Alcohol Use Disorder

Keywords

alcohol; cognitive training; intervention; neuroimaging

Outcome Measures

Primary Outcomes (1)

• Change in the Drinker Inventory of Consequences (DrInC)

  The DrInC assesses alcohol-related adverse functional consequences across physical (e.g., harmed physical health), interpersonal (e.g., loss of relationships), role responsibilities (e.g., missed work), psychological (e.g., loss of hobbies), and impulse control-related problems (e.g., legal problems) with higher scores indicating worse outcomes. Total scores range from 0 to 50.

  Baseline, post (week 6), follow up 1 (3 mo.), followup 2 (6 mo.)

Secondary Outcomes (3)

• Change in the Timeline Follow-back Procedure (TLFB)

  Baseline, post (week 6), follow up 1 (3 mo.), followup 2 (6 mo.)

• Change in Alcohol Approach Avoidance Behavioral Assessment (approach bias score)

  Baseline, post (week 6)

• Change in Alcohol Approach Avoidance Imaging Assessment (BOLD neural signal)

  Baseline, post (week 6)

Other Outcomes (5)

• Change in Sheehan Disability Scale (SDS)

  Baseline, post (week 6), follow up 1 (3 mo.), followup 2 (6 mo.)

• Change in The Substance Use Recovery Evaluator (SURE)

  Baseline, post (week 6), follow up 1 (3 mo.), followup 2 (6 mo.)

• Change in Alcohol Inhibition fMRI task (BOLD neural signal)

  Baseline, post (week 6)

Study Arms (2)

Approach Avoidance Training

EXPERIMENTAL

AAT condition, participants use a joystick to respond to the color of the border surrounding the stimulus images presented (i.e., "pull for green, push for blue"). The stimuli used are alcohol-related images and neutral beverage images. To experimentally manipulate automatic action tendencies, a contingency is set between alcohol stimuli and avoidance behaviors

Behavioral: Approach Avoidance Training

Sham Training

SHAM COMPARATOR

In the Sham participants use a joystick to respond to the color of the border surrounding stimulus images presented. There is no contingency between instruction type and pictures (i.e., non-training version of the task)

Behavioral: Sham Training

Interventions

Approach Avoidance Training BEHAVIORAL

AAT condition, participants use a joystick to respond to the color of the border surrounding the stimulus images presented (i.e., "pull for green, push for blue"). The stimuli used are alcohol-related images and neutral beverage images. To experimentally manipulate automatic action tendencies, a contingency is set between alcohol stimuli and avoidance behaviors

Also known as: AAT

Approach Avoidance Training

Sham Training BEHAVIORAL

In the Sham participants use a joystick to respond to the color of the border surrounding stimulus images presented. There is no contingency between instruction type and pictures (i.e., non-training version of the task)

Sham Training

Eligibility Criteria

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

You may qualify if:

• fluent in English
• primary diagnosis of AUD with no more than 90 days abstinence from alcohol
• week stability if taking psychotropic medications

You may not qualify if:

• lifetime history of psychotic or bipolar disorder
• neurodegenerative or neurodevelopmental disorders
• history of moderate or severe traumatic brain injury or other known neurological condition
• sensory deficits that would preclude completing tasks
• suicidal or homicidal ideation within the past month necessitating urgent higher level care
• concurrent individual psychotherapy or other treatment outside of standard DDRP programming
• conditions unsafe for completing MRI scanning for those completing the scanning component only (e.g., metal in body)

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA San Diego Healthcare System, San Diego, CA

San Diego, California, 92161-0002, United States

RECRUITING

Related Publications (1)

• Caudle MM, Klaming R, Fong C, Harle K, Taylor C, Spadoni A, Bomyea J. Approach avoidance training versus Sham in veterans with alcohol use disorder: protocol for a randomized controlled trial. BMC Psychiatry. 2023 Jul 12;23(1):499. doi: 10.1186/s12888-023-04961-z.

  PMID: 37438722 DERIVED

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Jessica A Bomyea, PhD

  VA San Diego Healthcare System, San Diego, CA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jessica A Bomyea, PhD

CONTACT

(858) 642-3720; jessica.bomyea@va.gov

Andrea Spadoni Townsend, PhD

CONTACT

(858) 855-8585; aspadoni@health.ucsd.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Randomization will occur using a code corresponding to intervention arm. Participant and provider will not know the number-condition link.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Two group randomized controlled trial of AAT versus comparator

Study Record Dates

• First Submitted: May 9, 2022
• First Posted: May 12, 2022
• Study Start: February 3, 2023
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: November 25, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)