Virtual Reality-Assisted Cognitive Behavioral Therapy for Alcohol Dependence (CRAVR-Pilot)
1 other identifier
interventional
10
1 country
1
Brief Summary
The pilot study is a single-blinded, randomized, controlled, 2 months clinical trial. The objective is to investigate the feasibility, effects and side-effects of virtual reality-assisted cognitive behavioral therapy (VR-CBT) vs. cognitive behavioral therapy (CBT) on alcohol intake in patients with a diagnosis of alcohol dependence.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started May 2021
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 11, 2021
CompletedFirst Submitted
Initial submission to the registry
June 15, 2021
CompletedFirst Posted
Study publicly available on registry
August 4, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 20, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 20, 2021
CompletedAugust 4, 2021
July 1, 2021
5 months
June 15, 2021
July 27, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Reduction in total alcohol consumption
Percent reduction in alcohol consumption, defined as "x" grams of alcohol for past 30 days. This will be registered using the Timeline-Follow-Back (TLFB) method.
From baseline to 1 week and 1 month after the third and final treatment session
Secondary Outcomes (11)
Reduction in heavy drinking days
Baseline,1 week and 1 month follow-up
Reduction in Alcohol Users Identification Test (AUDIT) score
Baseline, 1 week and 1 month follow-up
Reduction in Drug User Identification Test (DUDIT) score
Baseline, 1 week and 1 month follow-up
Reduction in Penn Alcohol Craving Scale (PACS) score
Baseline, 1 week and 1 month follow-up
Screening for Cognitive Impairment in Psychiatry (SCIP) score
Baseline, 1 week and 1 month follow-up
- +6 more secondary outcomes
Study Arms (2)
Virtual Reality Cognitive Behavioral Therapy (VRCBT)
EXPERIMENTALThe VR exposure is performed to induce alcohol craving during the therapy session, in order to trigger a lifelike response to alcohol, while the therapist is present and able to train the participant in applying CBT-based coping strategies to deal with the alcohol cravings.
Cognitive Behavioral Therapy (CBT)
ACTIVE COMPARATORCBT is made up of the following elements: i) recognition (ii) avoiding and (iii) overcoming drinking cravings in high-risk situations with the aim of preventing relapse.
Interventions
Participants in the intervention group will scheduled for 3 weekly treatment sessions based on manualized cognitive behavioral therapy assisted with alcohol-related high risk situations (6 different scenes from a restaurant) in virtual reality. From scene 1 to scene 6, alchol-related cues increase in intensity in order to perform gradual exposure therapy as a part of CBT. Furthermore, VR scenes are used in CBT to induce craving for coping strategy skill training and cognitive analysis.
The active comparator receives 3 conventional cognitive behavioral therapy sessions with 1 week intervals.
Eligibility Criteria
You may qualify if:
- Informed oral and written consent
- Meets criteria for alcohol dependence syndrome according to International Classification of Diseases (ICD) 10, WHO \& Diagnostic and Statistical Manual of Mental Disorder (DSM-5)
- Age 18 - 70 years old (both included)
- Minimum 5 'heavy drinking days' in the last month, which is defined as an alcohol intake above 60/48 grams or 5/4 items per. day for resp. men and women over the past 30 days
You may not qualify if:
- Other active substance use defined by DUDIT score\> 6 (for men)\> 2 (for women) and meet the criteria for other drug dependence according to ICD-10 (excluding nicotine)
- Does not speak or understand Danish
- Mental retardation or known severe psychiatric illness or other condition where it is assessed that will interfere with participation eg severely impaired vision or hearing.
- Medical alcohol treatment (disulfiram, acamprosate, naltrexone or nalmefen) within the latest 4 weeks and during the treatment period
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Novavi ambulatorierne
Copenhagen, Frederiksberg, 2000, Denmark
Related Publications (1)
Thaysen-Petersen D, Hammerum SK, Vissing AC, Oestrich IH, Nordentoft M, During SW, Fink-Jensen A. Virtual reality-assisted cognitive behavioral therapy for patients with alcohol use disorder: a randomized feasibility study. Front Psychiatry. 2024 Feb 14;15:1337898. doi: 10.3389/fpsyt.2024.1337898. eCollection 2024.
PMID: 38419905DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, MD, DMSci
Study Record Dates
First Submitted
June 15, 2021
First Posted
August 4, 2021
Study Start
May 11, 2021
Primary Completion
October 20, 2021
Study Completion
October 20, 2021
Last Updated
August 4, 2021
Record last verified: 2021-07
Data Sharing
- IPD Sharing
- Will not share