NCT06380985

Personalized Approach Bias Modification in Heavy Drinking Veterans With Mild to Moderate Traumatic Brain Injury

Personalized Approach Bias Modification to Reduce Heavy Drinking and Improve Cognitive Control in Veterans With Mild to Moderate Traumatic Brain Injury

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: VA Office of Research and Development · Federal
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The project will examine the neural associations of alcohol approach-bias and investigate the extent to which a neuroscience-based personalized cognitive training program will remediate alcohol approach-bias and improve recovery outcomes among heavy drinking Veterans with alcohol use disorder (AUD) and a history of mild-moderate traumatic brain injury (mmTBI). Alcohol approach-bias modification (ApBM) is a cognitive training intervention designed to interrupt and modify automatic approach processes in response to alcohol cues. Modification of alcohol approach-bias and reductions in heavy alcohol use can be expected to reduce behaviors of self-harm and violence, increase adherence to medical care, reduce drinking-related medical costs, and promote healthier relationships. The long-term goal is to demonstrate the efficacy of ApBM to promote recovery from AUD in Veterans with chronic mmTBI. The investigators also aim to identify neural mechanisms associated with ApBM and other neurocognitive predictors of successful recovery. The evidence garnered from this study will be useful to inform the development of other behavioral and pharmacological treatments for Veterans with AUD with a history of mmTBI.

Detailed description

This study is the first to test if Alcohol approach-bias modification (ApBM), delivered through virtual reality, as an add-on to outpatient treatment can reduce heavy alcohol use and improve neuro-cognitive outcomes among Veterans with mild to moderate traumatic brain injury (mmTBI) engaged in outpatient treatment for alcohol use disorder (AUD). This will be a Phase II double-blind, randomized, sham-controlled clinical trial. Approximately 100 heavy drinking Veterans with alcohol use disorder (AUD) and a history of mild to moderate traumatic brain injury (mmTBI) will be randomized into the study to complete a 3-week of either personalized ApBM or sham training (9 training sessions). Immediately following the 3-week training, a post-intervention Week-4 assessment will be administered. The participants will also be re-assessed again at Week 12 as the last study visit. The aims of the study are as follows: Aim 1: Establish the efficacy of a personalized alcohol ApBM to promote recovery from AUD among heavy drinking Veterans with a history of mmTBI. Aim 2: Evaluate alcohol ApBM related change in fMRI cue-induced craving outcomes of treatment response within Default Mode Network. Aim 3: Assess alcohol approach bias modification-related improvement in cognitive executive functioning domains that typically show deficit in heavy drinking Veterans with mmTBI and replicate preliminary associations between executive function domains and alcohol approach bias.

Conditions

• Alcohol Use Disorder
• Mild-Moderate Traumatic Brain Injury

Interventions

Type	Name	Description
BEHAVIORAL	Personalized VR Alcohol Approach Bias Modification (ApBM) Condition	The Personalized VR ApBM will consist of 2D pictures representing alcohol or positive images (e.g., representing family or friends enjoying time together; sports, pets; travel and holidays, etc.) presented in a unique format in VR (e.g., landscape/portrait orientation), which will serve as the cue requiring a stimulus response. Participants are instructed to push the images away from them if they are presented in one format (e.g., landscape) and grab (using lever on VR controller) the images and pull towards themselves in response to a separate format (e.g., portrait pictures) across a virtual table. Each training session starts with 10 practice trials showing neutral objects (containers), followed by 240 training trials (120 alcohol and 120 non-alcohol trials). Training effect is achieved by altering the contingency of push vs. pull by image type (alcohol vs. positive).
BEHAVIORAL	Sham Condition	Sham training is identical to ApBM, except the contingency of each orientation (e.g., portrait or landscape) representing a push vs. a pull is altered to diminish training effect.

Timeline

• Start date: 2024-06-24
• Primary completion: 2024-06-24
• Completion: 2024-06-24
• First posted: 2024-04-24
• Last updated: 2024-06-27

Locations

1 site across 1 country: United States