Virtual Reality Exposure Therapy in the Treatment of Alcohol Use Disorder (NCT05841823) | Clinical Trial Compass
CompletedNot Applicable
Virtual Reality Exposure Therapy in the Treatment of Alcohol Use Disorder
China80 participantsStarted 2023-06-01
Plain-language summary
This study aims to compare the efficacy of virtual reality exposure therapy (VRET) with treatment-as-usual (TAU) for alleviating psychological dependence on alcohol and preventing relapse. It also assesses the changes of EEG in patients with alcohol use disorder after completion of the above related interventions.
In this study 80 subjects with alcohol use disorder who have completed 2 weeks of in-patient detoxification will be randomized into two groups (VRET and treatment-as-usual control groups) and undergo respective interventions. Then assessment will be performed at four timelines (baseline, 4 weeks after baseline which is immediately after completion of intervention, 12 weeks after baseline, and 24 weeks after baseline assessment).
Who can participate
Age range
18 Years – 55 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Hospitalized patients diagnosed with alcohol use disorder (confirmed by the relevant diagnostic criteria of Diagnostic and Statistical Manual of Mental Disorders-V).
. Male, age 18 to 55 years old, Han nationality, junior high school education or above, right-handed (because of the difference in EEG between right-hand and left-hand).
. Those with normal eyesight (including corrected vision).
Exclusion criteria
. Those with current and lifetime history of abuse of any other psychoactive substances (except tobacco).
. Those with current and lifetime history of other mental diseases.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial used virtual reality exposure therapy specifically for alcohol use disorder and tracked craving scores using something called the Penn Alcohol Craving Scale — do you think targeting cravings this way could be relevant to my situation, and is VR-based therapy something available to me outside of a research setting?
2The trial also tracked alcohol withdrawal symptoms using the CIWA-Ar scale — does my current level of alcohol use put me at risk for withdrawal that would need to be managed, and would that affect which treatment approach is safest for me to start with?
3Since this study is already completed, would you be able to look at its published results to see whether virtual reality exposure therapy actually moved the needle on reducing drinking, and how does that compare to standard treatments you'd recommend for me?
4This trial was labeled 'Phase NA,' which I understand often applies to behavioral or device-based studies rather than drug trials — does that mean the safety profile of VR therapy is generally well understood, or are there still unknowns I should factor into my decision?
5Given that this trial measured outcomes at four different time points, what does that tell us about how long someone typically needs to stay engaged with this kind of therapy to see a meaningful change, and is that realistic given my schedule and life situation?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Alcohol Use Disorders Identification Test (AUDIT) score across four timelines
Timeframe: At four time points of assessment: t0 (baseline) = before starting intervention, t1 = 4 weeks which is immediately after completion of intervention, t2 = 12 weeks after intervention began, and t3 = 24 weeks after intervention began
2
Change in Clinical Institute Withdrawal Assessment-Alcohol, Revised (CIWA-Ar) score across four timelines
Timeframe: At four time points of assessment: t0 (baseline) = before starting intervention, t1 = 4 weeks which is immediately after completion of intervention, t2 = 12 weeks after intervention began, and t3 = 24 weeks after intervention began
3
Change in Penn Alcohol Craving Scale (PACS) score across four timelines
Timeframe: At four time points of assessment: t0 (baseline) = before starting intervention, t1 = 4 weeks which is immediately after completion of intervention, t2 = 12 weeks after intervention began, and t3 = 24 weeks after intervention began