Alcohol Dependence
Conditions
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.
Interventions
DEVICEVR Cue-Exposure Therapy
Standard VR Cue Exposure Therapy (VR-CET) for the treatment of alcohol dependence
Sponsors
Charite University, Berlin, Germany
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Craving | 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 | subjective craving for alcohol, measured with Visual Analogue Scales (VAS; 0 - 10 with higher scores indication higher craving levels) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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) |
Countries
Germany
Outcome results
None listed