Alcohol Use DisorderNCT04283305
Virtual Reality Alcohol Avoidance Training
A study testing Virtual reality approach avoidance training and Computer-based approach avoidance training in people with Alcohol Use Disorder, run by Universitätsklinikum Hamburg-Eppendorf.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Alcohol Use Disorder
- What is being tested?
- Virtual reality approach avoidance training and Computer-based approach avoidance training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2020to 31 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Randomized Controlled Trial of a Virtual Reality Based, Approach-avoidance Training Program for Alcohol Use Disorder
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.
Read the 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.
- Conditions
- Alcohol Use Disorder
- Being tested
- Virtual reality approach avoidance training, Computer-based approach avoidance training
- Keywords
- approach bias, virtual reality, training
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality approach avoidance trainingOther
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 trainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
The 14-item obsessive-compulsive drinking scale (OCDS) measures the degree of cravings experienced during the last seven days. Items are rated on scales ranging from 0 to 4. The higher the score, the more pronounced the cravings. The scale has two subscales: obsessive cravings score and compulsive cravings score. A total score is calculated based on these subscales, and it is possible to calculate a resistance/impairment and interference subscale score.
Measured: 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
The 40-item Alcohol Abstinence Self-Efficacy Scale (AASE) measures current level of temptation to drink alcohol and self-efficacy to abstain from drinking. The scale applies 20 situations representing typical drinking cues. Twenty items pertain to temptation levels, the other 20 items to self-efficacy. Items are rated on scales ranging from not at all (0) to extremely (4). The measure comprises the following sub-scales: (1) negative affect; (2) social interaction and positive states; (3) physical and other concerns; and (4) withdrawal and urges (40).
Measured: 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
The 30-item Barratt impulsiveness scale (BIS, Patton, Stanford, \& Barratt, 1995) assesses dimensions of impulsivity using three subscales: (1) attentional (attention and cognitive instability), (2) motor (motor and perseverance); and (3) non-planning (self-control and cognitive complexity). Items are rated on 4-point Likert scales ranging from 1 = very true for me to 4 = very false for me.
Measured: 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
The Beck Depression Inventory-II (BDI-II; Beck et a., 1996) is a 21-item multiple-choice instrument that measures the severity of depression. Each item is rated on a 4-point scale ranging from 0 to 3 based on severity.
Measured: at baseline (day 0), at post-test (right after 14 days training period) and at follow up (84 days after post-test)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2020
- Study start1 Mar 2020 (estimated)
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- None (open label)
- Enrolment
- 135 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Collaborators
- Odense University Hospital, Pomeranian Medical University Szczecin, European Regional Development Fund, Hochschule für Techink und Wirtschaft Berlin
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04283305
- Sponsor's protocol ID
- VR_AAT
- Status last verified
- Feb 2020
- First submitted
- 14 Feb 2020
- Last updated
- 25 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32605614
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of a Virtual Reality Based, Approach-avoidance Training Program for Alcohol Use Disorder
- ClinicalTrials.gov ID
- NCT04283305
- Acronym / sponsor ID
- VR_AAT
- Conditions
- Alcohol Use Disorder
- Keywords
- approach bias, virtual reality, training
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 135 participants (estimated)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Collaborators
- Odense University Hospital, Pomeranian Medical University Szczecin, European Regional Development Fund, Hochschule für Techink und Wirtschaft Berlin
- Study start
- 1 Mar 2020 (estimated)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Jul 2021 (estimated)
- First posted
- 25 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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
| Arm | Type | Receives |
|---|---|---|
| Virtual reality approach avoidance training | Experimental | Other: Virtual reality approach avoidance trainingParticipants 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. |
| Computer-based approach avoidance training | Active comparator | Other: Computer-based approach avoidance trainingParticipants 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. |
| 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual reality approach avoidance trainingIn 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. | Other | Virtual reality approach avoidance training |
| Computer-based approach avoidance trainingIn 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. | Other | Computer-based approach avoidance training |
Primary outcome
Changes in alcohol consumption
Time frame: at baseline (day 0), at post-test (right after 14 days training period) and at follow up (84 days after post-test)
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.
4 secondary outcomes
Changes in alcohol-related craving
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: at baseline (day 0), at post-test (right after 14 days training period) and at follow up (84 days after post-test)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2020.
- Derived from this study: PubMed 32605614Mellentin 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality approach avoidance training and Computer-based approach avoidance training in people with Alcohol Use Disorder, run by Universitätsklinikum Hamburg-Eppendorf.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Simone Kühn, Prof. Dr. (040741024115, l.ascone-michelis@uke.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in alcohol consumption (time frame: at baseline (day 0), at post-test (right after 14 days training period) and at follow up (84 days after post-test)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04283305, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2020; AzTrials last refreshed its copy on 29 Oct 2026.