Clinical trial NCT06333457: Presence and Relapse Rates in Patients with Alcohol Use Disorder Using Virtual Reality
Official title: Presence and Relapse Rates in Patients with Alcohol Use Disorder Using Virtual Reality
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Alcohol Dependence
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2024-03-27
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with alcohol dependence treated in the inpatient or outpatient psychiatric clinics or day clinics of the Psychiatric University Hospital Charité at St. Hedwig-Hospital/ Department of Psychiatry and Neurosciences Campus Charité Mitte/ Theodor-Wenzel Werk Berlin / Jüdisches Krankenhaus Berlin / Vivantes Auguste-Viktoria-Klinikum

Brief summary: Investigation of the influence of the sense of presence during a Virtual Reality Cue-Exposure Therapy (VR-CET) with alcohol-associated cues on craving and relapse rates.

Study group: abstinent patients (at least 18 years old) with a diagnosed alcohol dependence after completed inpatient withdrawal treatment in the the last 3 months.

Primary hypothesis: the experience of presence during a virtual presentation of alcohol in alcohol-dependent patients is associated with levels of craving for alcohol during VR-CET.


Eligibility criteria: Inclusion Criteria:

* age: 18-65 years
* diagnosis of alcohol dependence according to ICD-10 (F10.2)
* completed in-patient withdrawal treatment during the last 3 months
* history of alcohol craving, confrmed via craving questionnaires
* able to provide written informed consent

Exclusion Criteria:

* substance dependence other than alcohol and nicotine
* current alcohol intoxication (randomly tested via measurement of breath alcohol concentration)
* unable to understand the study information, consent form or principles of the study
* abstinence for less than 7 days or on-going consumption of alcohol
* severe neuropsychiatric disorder, e.g., schizophrenia spectrum disorders, bipolar afective disorder or substantial cognitive impairment
* somatic diseases for which VR is associated with risks, e.g. photosensitive epilepsy
* acute suicidality or acute endangerment of others
* concurrent pharmacological treatment targeting AUD (i.e. benzodiazepines) or craving (i.e. acamprosate, disulfram, naltrexone, nalmefene)

Primary outcomes:
measure: Craving
timeFrame: VR-group: 6 appointments/6 weeks. Every appointment pre, during (approx. 20 min VR exposure) and post VR exposure / control group: 6 appointments/6 weeks, measures once every appointment, both groups: follow up appointments after 6 weeks + after 12 weeks
measure: Craving
timeFrame: VR-group: 6 appointments/6 weeks. Every appointment pre and post VR exposure / control group: 6 appointments/6 weeks, measures once every appointment, both groups: follow up appointments after 6 weeks + after 12 weeks
measure: Craving
timeFrame: VR-group: 6 appointments/6 weeks. Every appointment pre VR exposure / control group: 6 appointments/6 weeks, measures once every appointment, both groups: follow up appointments after 6 weeks + after 12 weeks
Secondary outcomes:
measure: Relapse rates
timeFrame: both groups: follow up appointment after 6 weeks, follow up appointment after 12 weeks
measure: Quality of Life
timeFrame: both groups: assessment during appointment 1 and 6 and during follow up appointments after 6 and 12 weeks
measure: Motion Sickness
timeFrame: VR group: pre and post VR exposure (6 appointments/6 weeks)
measure: Presence in VR
timeFrame: VR group: post VR exposure (6 appointments/6 weeks)
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Psychiatric University Hospital Charité at St. Hedwig Hospital
Study officials:
References: