Presence and Relapse Rates in Patients with Alcohol Use Disorder Using Virtual Reality

Recruiting

• Conditions: Alcohol Dependence

• Registration Number: NCT06333457
• Lead Sponsor: Charite University, Berlin, Germany

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-03-17
• Study First Submitted QC: 2024-03-23
• Study First Posted: 2024-03-27
• Study Start: 2024-04-01
• Status Verified: 2024-05
• Last Update Submitted: 2025-02-10
• Last Update Posted: 2025-02-12
• Primary Completion: 2025-04-30
• Study Completion: 2025-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Craving	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	subjective craving for alcohol, measured with Obsessive Compulsive Drinking Scale (OCDS, scores 0-56; higher scores indicating higher craving levels)

Secondary Outcome Measures

Name	Time	Method
Quality of Life	both groups: assessment during appointment 1 and 6 and during follow up appointments after 6 and 12 weeks	Assessment of quality of life via WHOQOL-BREF questionnaire, 0-100% (higher scores indicating better quality of life)
Motion Sickness	VR group: pre and post VR exposure (6 appointments/6 weeks)	Assessment of VR motion sickness using the Simulator Sickness Questionnaire (SSQ; scores from 0-48, higher scores indicating more side effects)
Presence in VR	VR group: post VR exposure (6 appointments/6 weeks)	Igroup Presence Questionnaire (IPQ; score range from 0 to 84, with higher scores indicating more realistic perceptions)
Relapse rates	both groups: follow up appointment after 6 weeks, follow up appointment after 12 weeks	TLFB (timeline followback method) for assessment of individual's alcohol intake

Trial Locations

Locations (1)

Psychiatric University Hospital Charité at St. Hedwig Hospital; 🇩🇪 Berlin, Germany