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A randomized controlled trial of a virtual reality based, approach-avoidance training program for alcohol use disorder: a study protocol.

ABSTRACT: BACKGROUND:The approach-avoidance training program (AATP) has shown preliminary promise as an add-on to standard treatment for alcohol dependence. However, knowledge is lacking as to whether the effectiveness of AATP can be enhanced further when performed in a typical drinking situation. The main aim of this study is to investigate whether approach-avoidance training implemented in a virtual reality bar environment is superior to the classical joystick PC-version of the AATP. METHODS:The study will be implemented as a randomized controlled trial. A total of 204consecutively enrolled alcohol use disorder (AUD) patients, recruited from alcohol inpatient clinics in Germany, Poland and Denmark, will be randomized into one of three groups at the start of standard alcohol treatment: group A) stimuli-relevant AATP + treatment as usual (TAU); group B) stimuli-relevant AATP in virtual reality + TAU, and group C) TAU only (control group). Treatment outcomes will be assessed at pre-treatment, post-treatment and 3-month follow-up. Repeated-measures ANOVA will be applied to compare the trajectories of the groups over time on drinking, craving and impulsiveness outcomes. It is hypothesized that the two experimental groups will achieve better treatment outcomes compared to group C and that group B will achieve better outcomes than group A. DISCUSSION:This study is the first trial examining the effectiveness of stimuli-relevant AATP delivered in a VR environment. The use of VR has shown promise in enhancing the effectiveness of other psychological treatments and since AATP has already been shown effective as add-on treatment, it is of interest to investigate whether these effects can be further enhanced by implementing the program in more ecologically valid environments. If proven effective, the AATP-VR can, like the AATP, be implemented easily and cheaply as add-on treatment or continued care to enhance the effectiveness of current evidence-based treatment. TRIAL REGISTRATION:ClinicalTrials.gov ID: NCT04283305 Registration date: 24.02.20.

SUBMITTER: Mellentin AI

PROVIDER: S-EPMC7324964 | biostudies-literature | 2020 Jun

REPOSITORIES: biostudies-literature

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A randomized controlled trial of a virtual reality based, approach-avoidance training program for alcohol use disorder: a study protocol.

Mellentin Angelina Isabella AI Nielsen Anette Søgaard AS Ascone Leonie L Wirtz Janina J Samochowiec Jerzy J Kucharska-Mazur Jolanta J Schadow Friedrich F Lebiecka Zofia Z Skoneczny Tomasz T Mistarz Nicolai N Bremer Thomas T Kühn Simone S

BMC psychiatry 20200630 1

<h4>Background</h4>The approach-avoidance training program (AATP) has shown preliminary promise as an add-on to standard treatment for alcohol dependence. However, knowledge is lacking as to whether the effectiveness of AATP can be enhanced further when performed in a typical drinking situation. The main aim of this study is to investigate whether approach-avoidance training implemented in a virtual reality bar environment is superior to the classical joystick PC-version of the AATP.<h4>Methods< ...[more]

PMID: 32605614

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Project description:BackgroundAlcohol use disorder (AUD) is highly prevalent and commonly co-occurs with other psychiatric disorders among Veterans. Provisional evidence supports the use of Approach Avoidance Training (AAT) - a form of computer-delivered cognitive bias modification designed to target implicit approach bias for alcohol-related cues - as an adjunctive program to treat AUD. However, the extent to which AAT is effective for improving AUD recovery outcomes in outpatient Veteran samples and those with psychiatric comorbidities has been understudied to date. Here we describe a double-blind randomized controlled trial of AAT versus a comparison condition (Sham) being conducted in Veterans with comorbid psychiatric conditions completing outpatient standard care.MethodsOne hundred thirty-six Veterans currently receiving outpatient treatment for AUD will be recruited for this randomized controlled trial with parallel group assignment. Participants will be randomized to either 6 weeks of AAT (n = 68) or Sham (n = 68) training in conjunction with usual care. Assessments will occur at baseline and 6 weeks, 3 months, and 6 months post-baseline. Primary outcome variables will include functional consequences of drinking. Secondary outcome variables will include alcohol consumption, and behavioral indicators of alcohol approach bias. A subset of participants (n = 51) will also complete functional magnetic resonance imaging (fMRI) to assess neural response during an alcohol approach bias assessment.DiscussionThis study is the first randomized controlled trial of AAT administered as an adjunctive treatment to standard care in Veterans with AUD and comorbid psychiatric disorders. Additionally, behavioral and neuroimaging data will be used to determine the extent to which AAT targets approach bias for alcohol cues. If effective, AAT may be a promising low-cost adjunctive treatment option for individuals with AUD.Registry nameAAT for Alcohol Use Disorder in Veterans.Trial registrationClinicalTrials.gov: NCT05372029; Date of Registration: 5/9/2022.

Project description:BackgroundAlcohol use disorder (AUD) has been associated with diverse physical and mental morbidities. Among the main consequences of chronic and excessive alcohol use are cognitive and executive deficits. Some of these deficits may be reversed in specific cognitive and executive domains with behavioral approaches consisting of cognitive training. The advent of computer-based interventions may leverage these improvements, but randomized controlled trials (RCTs) of digital interactive-based interventions are still scarce.ObjectiveThe aim of this study is to explore whether a cognitive training approach using VR exercises based on activities of daily living is feasible for improving the cognitive function of patients with AUD undergoing residential treatment, as well as to estimate the effect size for this intervention to power future definitive RCTs.MethodsThis study consisted of a two-arm pilot RCT with a sample of 36 individuals recovering from AUD in a therapeutic community; experimental group participants received a therapist-guided, VR-based cognitive training intervention combined with treatment as usual, and control group participants received treatment as usual without cognitive training. A comprehensive neuropsychological battery of tests was used both at pre- and postassessments, including measurement of global cognition, executive functions, attention, visual memory, and cognitive flexibility.ResultsIn order to control for potential effects of global cognition and executive functions at baseline, these domains were controlled for in the statistical analysis for each individual outcome. Results indicate intervention effects on attention in two out of five outcomes and on cognitive flexibility in two out of six outcomes, with effect sizes in significant comparisons being larger for attention than for cognitive flexibility. Patient retention in cognitive training was high, in line with previous studies.ConclusionsOverall, the data suggest that VR-based cognitive training results in specific contributions to improving attention ability and cognitive flexibility of patients recovering from AUD.Trial registrationClinicalTrials.gov NCT04505345; https://clinicaltrials.gov/show/NCT04505345.

Dataset Information

A randomized controlled trial of a virtual reality based, approach-avoidance training program for alcohol use disorder: a study protocol.

Publications

A randomized controlled trial of a virtual reality based, approach-avoidance training program for alcohol use disorder: a study protocol.

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