Clinical trial NCT04283305: Virtual Reality Alcohol Avoidance Training
Official title: A Randomized Controlled Trial of a Virtual Reality Based, Approach-avoidance Training Program for Alcohol Use Disorder
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Alcohol Use Disorder
Keywords: approach bias
virtual reality
training
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
Collaborators: name: Odense University Hospital
name: Pomeranian Medical University Szczecin
name: European Regional Development Fund
name: Hochschule für Techink und Wirtschaft Berlin
First posted: 2020-02-25
Enrollment: 135
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are randomly assigned to one of three conditions:

1. = virtual reality approach avoidance training
2. = computer-based approach avoidance training
3. = treatment as usual
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: The study will be implemented as a randomized controlled trial. A total of 135 consecutively 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 as usual; group B) stimuli-relevant ATTP in virtual reality, and group C) treatment as usual (TAU; control group). Treatment outcomes will be assessed at pre-treatment, post-treatment and 3-month follow-up. Generalized mixed-models will be applied to compare the trajectories of the groups over time on drinking, craving and impulsiveness outcomes.

Eligibility criteria: Inclusion Criteria:

* signed written informed consent
* meeting the diagnostic criteria for alcohol use disorder
* fluent in language of the participating country (German, Polish or Danish)
* completion of detoxification (if needed)
* enrolled in standard treatment within two weeks

Exclusion Criteria:

* any sensory or motor deficits complicating the provision of the AAT (e.g. color-blindness, fine or gross motor deficits in upper extremities)
* meeting diagnostic criteria for other substance use disorders
* severe psychiatric or neurological illness (e.g. psychotic disorders, mental retardation, dementia) or terminal somatic illness

Primary outcomes:
measure: Changes in alcohol consumption
timeFrame: at baseline (day 0), at post-test (right after 14 days training period) and at follow up (84 days after post-test)
Secondary outcomes:
measure: Changes in alcohol-related craving
timeFrame: at baseline (day 0), at post-test (right after 14 days training period) and at follow up (84 days after post-test)
measure: Changes in alcohol abstinence self-efficacy
timeFrame: at baseline (day 0), at post-test (right after 14 days training period) and at follow up (84 days after post-test)
measure: Changes in impulsivity
timeFrame: at baseline (day 0), at post-test (right after 14 days training period) and at follow up (84 days after post-test)
measure: Changes in depression severity
timeFrame: at baseline (day 0), at post-test (right after 14 days training period) and at follow up (84 days after post-test)
Other outcomes:
measure: Changes in Alcohol related Approach Bias
timeFrame: at baseline (day 0), at post-test (right after 14 days training period) and at follow up (84 days after post-test)
measure: Changes in cue-induced cravings
timeFrame: at baseline (day 0), at post-test (right after 14 days training period) and at follow up (84 days after post-test)
measure: Changes in alcohol-related response inhibition
timeFrame: at baseline (day 0), at post-test (right after 14 days training period) and at follow up (84 days after post-test)
Locations:
Study officials:
References:
citation: Mellentin AI, Nielsen AS, Ascone L, Wirtz J, Samochowiec J, Kucharska-Mazur J, Schadow F, Lebiecka Z, Skoneczny T, Mistarz N, Bremer T, Kuhn S. A randomized controlled trial of a virtual reality based, approach-avoidance training program for alcohol use disorder: a study protocol. BMC Psychiatry. 2020 Jun 30;20(1):340. doi: 10.1186/s12888-020-02739-1.