Virtual Reality-Assisted Cognitive Behavioral Therapy for Alcohol Dependence (CRAVR)
1 other identifier
interventional
102
1 country
1
Brief Summary
The study is a single-blinded, randomized, controlled, 12 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) 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 P50-P75 for phase_2
Started Oct 2021
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
First Submitted
Initial submission to the registry
July 27, 2021
CompletedFirst Posted
Study publicly available on registry
September 13, 2021
CompletedStudy Start
First participant enrolled
October 6, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2024
CompletedNovember 10, 2021
November 1, 2021
2.4 years
July 27, 2021
November 9, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Reduction in total alcohol consumption
Percent change in alcohol consumption, defined as "x" grams of alcohol for past 30 days. This will be registered using the Timeline-Follow-Back (TLFB) method.
Baseline, 6 months, 9 months, 12 months
Secondary Outcomes (12)
Change in heavy drinking days
Baseline, 6 months, 9 months, 12 months
Change in Alcohol Users Identification Test (AUDIT) score
Baseline, 6 months, 9 months, 12 months
Change in Drug User Identification Test (DUDIT) score
Baseline, 6 months, 9 months, 12 months
Change in Penn Alcohol Craving Scale (PACS) score
Baseline, 6 months, 9 months, 12 months
Screening for Cognitive Impairment in Psychiatry (SCIP) score
Baseline, 6 months, 9 months, 12 months
- +7 more secondary outcomes
Study Arms (2)
Virtual Reality Cognitive Behavioral Therapy (VRCBT)
EXPERIMENTALThe VR exposure is performed to induce alcohol craving and high-risk induced reactions 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 14 treatment sessions based on manualized cognitive behavioral therapy assisted with alcohol-related high risk situations in virtual reality. VR-assisted gradual exposure therapy is integrated as a part of CBT. I.e. VR scenes are used in CBT to induce craving for coping strategy skill training and cognitive analysis.
The active comparator receives 14 conventional cognitive behavioral therapy sessions with
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 (2)
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: 38419905DERIVEDThaysen-Petersen D, Hammerum SK, Vissing AC, Arnfred BT, Nordahl R, Adjorlu A, Nordentoft M, Oestrich IH, During SW, Fink-Jensen A. Virtual reality-assisted cognitive behavioural therapy for outpatients with alcohol use disorder (CRAVR): a protocol for a randomised controlled trial. BMJ Open. 2023 Mar 29;13(3):e068658. doi: 10.1136/bmjopen-2022-068658.
PMID: 36990475DERIVED
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
July 27, 2021
First Posted
September 13, 2021
Study Start
October 6, 2021
Primary Completion
March 1, 2024
Study Completion
March 1, 2024
Last Updated
November 10, 2021
Record last verified: 2021-11
Data Sharing
- IPD Sharing
- Will not share