Virtual Reality Alcohol Avoidance Training

NCT04283305 | Unknown

• 1 other identifier: VR_AAT
• Study Type: interventional
• Target: 135
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Alcohol Use Disorder

Keywords

approach bias; virtual reality; training

Outcome Measures

Primary Outcomes (1)

• Changes in alcohol consumption

  Alcohol consumption measures will be derived from the Timeline Followback (TLFB). The TLFB method involves using a calendar to identify alcohol consumption patterns in terms of number of drinks per day during the last 30 days. One drink is defined as 12 grams of ethanol. The Visual Analogue Scale (VAS) comprises single items used to measure the degree of alcohol cravings on scales ranging from 0-100, with 0 representing no cravings and 100 an extreme degree of cravings. The scale is presented visually on a ruler, and the individual will be requested to report the frequency, mean level and the peak level of cravings experienced during the last 30 days.

  at baseline (day 0), at post-test (right after 14 days training period) and at follow up (84 days after post-test)

Secondary Outcomes (4)

• Changes in alcohol-related craving

  at baseline (day 0), at post-test (right after 14 days training period) and at follow up (84 days after post-test)

• Changes in alcohol abstinence self-efficacy

  at baseline (day 0), at post-test (right after 14 days training period) and at follow up (84 days after post-test)

• Changes in impulsivity

  at baseline (day 0), at post-test (right after 14 days training period) and at follow up (84 days after post-test)

• Changes in depression severity

  at baseline (day 0), at post-test (right after 14 days training period) and at follow up (84 days after post-test)

Other Outcomes (3)

• Changes in Alcohol related Approach Bias

  at baseline (day 0), at post-test (right after 14 days training period) and at follow up (84 days after post-test)

• Changes in cue-induced cravings

  at baseline (day 0), at post-test (right after 14 days training period) and at follow up (84 days after post-test)

• Changes in alcohol-related response inhibition

  at baseline (day 0), at post-test (right after 14 days training period) and at follow up (84 days after post-test)

Study Arms (3)

Virtual reality approach avoidance training

EXPERIMENTAL

Participants will receive six sessions (three sessions per week for two weeks; session duration = 30 mins) of approach-avoidance training in the virtual reality. Alcoholic beverages are pushed away with a controller and soft-drinks will be pulled towards oneself. Training will begin approximately three weeks before discharge from the inpatient clinics to measure the add-on effect and to ensure that the add-on treatment does not extend the treatment period.

Other: Virtual reality approach avoidance training

Computer-based approach avoidance training

ACTIVE COMPARATOR

Participants will receive six sessions (three sessions per week for two weeks; session duration = 30 mins) of approach-avoidance training on the computer. Alcoholic beverages are pushed away with a joystick and soft-drinks will be pulled towards oneself. Training will begin approximately three weeks before discharge from the inpatient clinics to measure the add-on effect and to ensure that the add-on treatment does not extend the treatment period.

Other: Computer-based approach avoidance training

Treatment as usual

NO INTERVENTION

Participants will receive treatment as usual on the wards. For ethical reasons, participants in this condition will get the offer to undertake the already scientifically validated computer-based approach avoidance training after their completion of the study.

Interventions

Virtual reality approach avoidance training OTHER

In the VR-based AAT, patients are situated in a bar environment where drinks appear on a bar table in front of them. Patients are instructed to react to 100% of the alcoholic beverages with a push response with a controller, and to non-alcoholic drinks in 100% of the trials with a pull response. The stimuli set consists of 50 different beverages, which are displayed three times in total.

Virtual reality approach avoidance training

Computer-based approach avoidance training OTHER

In the computer-based AAT, patients are situated in front of a computer where drinks appear on the screen in front of them. Patients are instructed to react to 100% of the alcoholic beverages with a push response with a joystick, and to non-alcoholic drinks in 100% of the trials with a pull response. The stimuli set consists of 50 different beverages, which are displayed three times in total.

Computer-based approach avoidance training

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead
• Odense University Hospital: collaborator
• Pomeranian Medical University Szczecin: collaborator
• European Regional Development Fund: collaborator
• Hochschule für Techink und Wirtschaft Berlin: collaborator

Related Publications (1)

• 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.

  PMID: 32605614 DERIVED

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Simone Kühn, Prof. Dr.

CONTACT

040741024115; l.ascone-michelis@uke.de

Leonie Ascone, Dr. phil.

CONTACT

040741024115; s.kuehn@uke.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: February 14, 2020
• First Posted: February 25, 2020
• Study Start: March 1, 2020
• Primary Completion: December 31, 2020
• Study Completion: July 31, 2021
• Last Updated: February 25, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share