alcohol use disorder - alcohol dependency addicted to alcohol - alcohol addiction - alcoholism - drinking addiction
Conditions
Interventions
The application under investigation is ROCOVRY 3.0, developed to be used with a Meta Quest 2 headset. It includes a menu with (a) different environments to either evoke graving (orange and read enviro
Sponsors
Stichting Novadic-Kentron
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: (a) primary dependence of alcohol (b) age between 18 and 65 years (c) sufficient understanding of the Dutch language (d) agree on the outpatient treatment modality (e) eligible for signing an informed consent (f) does not want to receive refusal as medication and (g) is prepared to strive towards abstinence
Exclusion criteria
Exclusion criteria: (a) severe psychiatric disorders like psychosis (hallucinations and delusions), severe depression or severe suicidal ideations (b) severe poly-drug use (in such a way that it interferes with the treatment) (c) severe somatic diseases (like cardiovascular diseases, pulmonary disease (e.g., COPD) etc.) (d) mentally impaired/incompetent (not able to fill-out questionnaires) (e) pregnancy (f) homelessness and (g) those having severe motion sickness (h) implanted medical devices such as pacemakers, hearing aids or ICDs and (i) contagious conditions, particularly around the head
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcomes of study 1 are the user experience with the technology assessed through the technology acceptance model which addresses the perceived usability, the perceived ease of use and the intention and motivation to use the VRET application as part of the treatment. The experiences and thoughts during the sessions will be audio recorded according to the think aloud method. Also, the sessions will be video recorded. Both recordings will give extra possibilities to investigate the personal experiences of the participant and learn from it. It concerns the response how they deal with resisting graving and remaining abstinent during the treatment. There also is a focus on design evaluation concerning the level of realism.Study 2, the RCT, focuses on the use of quantitative measurement instruments. The primary measure is the number of days alcohol abstinence (TLFB). | — |
Secondary
| Measure | Time frame |
|---|---|
| In study one the secondary study parameters are the quantitative measures of:Self-efficacyLonging for alcohol or craving Number of days alcohol abstinenceMental health statusVital signs such as blood pressure, heart rate, body temperature, and respiratory rate before and after the virtual reality sessions.Adverse events/side effects of virtual reality (e.g., using the similar sickness questionnaire [SSQ])Preference of the level of realism of the environments (360° versus computer generated virtual worlds or mixed) and avatars (low versus a high level of realism)Sence of being present in virtual reality environments and The transition interview on the day of discharge from the clinic and an exit interview on the last day of the investigation after three months will be conducted.The secondary study parameters of study 2 are the relapse frequency (the return to pre-treatment drinking levels; Conners et al., 1996) during the first-year follow-up as the number of readmissions in this period. Also craving levels (VAS); the level of self-control (SELD-R) and the mental health status will be investigated. An interview will be conducted at the end of the clinical period, the termination of the treatment and the completion of the study. The short-term (three months) and the long-term (1 year follow-up) effects of VRET will also be investigated in terms of mental, physical, emotional, and behavioral effects (side effects and safety). | — |
Countries
Netherlands
Contacts
Public ContactV.J.A. Buwalda
Novadic-Kentron
Outcome results
None listed