AAT for Alcohol Use Disorder in Veterans

NCT ID: NCT05372029

Last Updated: 2025-11-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 176 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-03
• Study Completion Date: 2026-09-30

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.

Detailed Description

Veterans with alcohol use disorders (AUD) would be greatly served by development of effective interventions to address high relapse rates and difficulty with resuming optimal functional recovery (i.e., re-engaging in vocational, social, and daily life roles that are critical to maintaining alcohol consumption goals). Approach bias toward alcohol, an implicit motivational response to alcohol cues observable across behavioral and neural indicators, is a core feature of AUD that impedes recovery but is not routinely treated in standard care. Treatment options that target approach bias may improve outcomes by decreasing the appetitive pull of alcohol, so that individuals are better able to disengage from habitual drinking behaviors in the service of their functional goals and objectives. Approach Avoidance Training (AAT) is a computer-delivered treatment program that shifts behavioral and neural indicators of approach bias for alcohol and has been shown to improve drinking-related outcomes in AUD when used in conjunction with standard care. Given the promise of this intervention for AUD, there is a critical need to determine if this treatment can be successfully used for Veterans who commonly present with complex comorbidities, and to pinpoint cognitive and neurobiological processes of change. The overall objectives of this proposal are to determine whether Alcohol Approach Avoidance Training (AAT) improves recovery outcomes in Veterans undergoing standard care for AUD with co-occurring conditions, and to identify the underlying cognitive and neural substrates modified. The central hypothesis is that AAT training will improve critical recovery outcomes for Veterans and improve behavioral and neural indicators of approach bias. The investigators will explore whether effects of AAT generalize to related top-down and bottom-up neurocognitive processes. The investigators will also explore potential predictors of treatment response. The overall objectives will be addressed in a randomized controlled trial of 136 Veterans completing standard care in the local VA setting with either AAT or a control condition. Aim 1 will determine if repeatedly practicing avoidance of alcohol cues through AAT can improve recovery outcomes and hazardous drinking. Aim 2 will determine if AAT modifies approach bias by measuring this construct with multiple assessment methods (i.e., behavioral, fMRI). Exploratory aims will examine if AAT modifies inhibition (top-down) and cue reactivity (bottom up) processing, and the extent to which baseline comorbidity severity, treatment engagement characteristics, or baseline approach bias (behavioral task reaction times, brain response during fMRI) are associated with clinical outcomes. The project is expected to determine if AAT shows clinical potential that would warrant expansion to other substances of abuse and a larger multisite confirmatory efficacy trial in Veterans with AUD. Results of the study will inform the utility of AAT as an adjunctive AUD treatment for Veterans, potentially offering a novel, low-cost, and portable alternative option to improve recovery in these individuals. Consistent with the RR&D mission to maximize "functional independence, quality of life and participation in their lives and community," the project will provide a foundation for neuroscience-based alternative therapeutic options to improve recovery in Veterans with AUD.

Conditions

Alcohol Use Disorder

Study Design

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

Study Groups

Approach Avoidance Training

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

Group Type: EXPERIMENTAL

Approach Avoidance Training

Intervention Type: 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

Sham Training

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)

Group Type: SHAM_COMPARATOR

Sham Training

Intervention Type: 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)

Interventions

Approach Avoidance Training

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

Intervention Type: BEHAVIORAL

Sham Training

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)

Intervention Type: BEHAVIORAL

Other Intervention Names

AAT

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 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

Jessica A Bomyea, PhD

Role: PRINCIPAL_INVESTIGATOR

VA San Diego Healthcare System, San Diego, CA

Locations

VA San Diego Healthcare System, San Diego, CA

San Diego, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Jessica A Bomyea, PhD

Role: CONTACT

jessica.bomyea@va.gov

(858) 642-3720

Andrea Spadoni Townsend, PhD

Role: CONTACT

aspadoni@health.ucsd.edu

(858) 855-8585

Facility Contacts

Jessica A Bomyea, PhD

Role: primary

jessica.bomyea@va.gov

858-642-3720

References

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.

Reference Type: DERIVED

PMID: 37438722 (View on PubMed)

Other Identifiers

D3793-R

Identifier Type: -

Identifier Source: org_study_id