Virtual Reality Alcohol Avoidance Training

NCT ID: NCT04283305

Last Updated: 2020-02-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

135 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-01

Study Completion Date

2021-07-31

Brief Summary

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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

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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.

Conditions

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Alcohol Use Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Virtual reality approach avoidance training

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.

Group Type EXPERIMENTAL

Virtual reality approach avoidance training

Intervention Type 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.

Computer-based approach avoidance training

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.

Group Type ACTIVE_COMPARATOR

Computer-based approach avoidance training

Intervention Type 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.

Treatment as usual

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Virtual reality approach avoidance training

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.

Intervention Type OTHER

Computer-based approach avoidance training

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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Odense University Hospital

OTHER

Sponsor Role collaborator

Pomeranian Medical University Szczecin

OTHER

Sponsor Role collaborator

European Regional Development Fund

OTHER

Sponsor Role collaborator

Hochschule für Techink und Wirtschaft Berlin

UNKNOWN

Sponsor Role collaborator

Universitätsklinikum Hamburg-Eppendorf

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Simone Kühn, Prof. Dr.

Role: CONTACT

040741024115

Leonie Ascone, Dr. phil.

Role: CONTACT

040741024115

References

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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.

Reference Type DERIVED
PMID: 32605614 (View on PubMed)

Other Identifiers

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VR_AAT

Identifier Type: -

Identifier Source: org_study_id

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