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Virtual Reality-Assisted Cognitive Behavioral Therapy for Alcohol Dependence (CRAVR)

Primary Purpose

Alcohol Dependence, in Remission, Addiction, Alcohol

Status
Recruiting
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
Virtual Reality Cognitive Behavioral Therapy (CRAVR)
CBT
Sponsored by
Psychiatric Centre Rigshospitalet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Dependence, in Remission focused on measuring Alcohol, Addiction, Virtual Reality, Exposure Therapy, Cognitive Behavioral Therapy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Novavi ambulatorierneRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Virtual Reality Cognitive Behavioral Therapy (VRCBT)

Cognitive Behavioral Therapy (CBT)

Arm Description

The 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.

CBT 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in heavy drinking days
Based on the past 30 days of alcohol consumption using time line follow-back (TLFB), heavy drinking days are evaluated. 1 heavy drinking day consists of alcohol consumption exceeding 60/48 grams for men and women respectively.
Change in Alcohol Users Identification Test (AUDIT) score
Screening for excessive drinking. Higher score = worse outcome
Change in Drug User Identification Test (DUDIT) score
Identification of individuals with drug-related problems. Higher score = worse outcome
Change in Penn Alcohol Craving Scale (PACS) score
Assessing alcohol craving. Higher score = worse outcome
Screening for Cognitive Impairment in Psychiatry (SCIP) score
The 20 minute test is a scale developed for screening cognitive deficits. Higher score = better outcome
Change in Global Assessment of functioning (GAF) score
GAF measures to what degree a person's symptoms affect their daily functioning on a scale of 0 to 100. Higher score = better outcome
Becks Anxiety Inventory (BAI) score
Measures the severity of anxiety. Higher score = worse outcome
Becks Depression Inventory 2 (BDI-II) score
Measures the severity of depression. Higher score = worse outcome
Simulator Sickness Questionnaire (SSQ)
Measures whether participants experience symptoms of simulator sickness while in Virtual Reality. Higher score = worse outcome
VR-induced craving on a visual analog scale (VAS)
For each of the 6 VR-scenes, craving is evaluated before, during and after exposure as well as at the end of the therapy session
Alcohol withdrawal symptoms
Alcohol withdrawal symptoms are evaluated at inclusion. Higher score = worse outcome
Qualitative assessment
15 patients and 5 therapists will be asked about advantages and disadvantages of using virtual reality

Full Information

First Posted
July 27, 2021
Last Updated
November 9, 2021
Sponsor
Psychiatric Centre Rigshospitalet
Collaborators
The Novavì outpatient clinics, Copenhagen
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1. Study Identification

Unique Protocol Identification Number
NCT05042180
Brief Title
Virtual Reality-Assisted Cognitive Behavioral Therapy for Alcohol Dependence (CRAVR)
Official Title
Virtual Reality-Assisted Cognitive Behavioral Therapy for Alcohol Dependence: A Randomized Controlled Trial (CRAVR)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
October 6, 2021 (Actual)
Primary Completion Date
March 1, 2024 (Anticipated)
Study Completion Date
March 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Psychiatric Centre Rigshospitalet
Collaborators
The Novavì outpatient clinics, Copenhagen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Recruitment of participants: 102 patients will be recruited from the Novaví outpatient clinics, where they will be informed orally and in writing about the research project and, if they are interested, an information meeting is booked. If patients show symptoms of abstinence, these are treated prior to the information meeting by doctors and nurses in Novaví. If the patient then wishes to participate and meets the inclusion criteria, informed consent is obtained and screening is performed using the questionnaires described later. Included patients will then be randomized to either: Virtual reality-assisted cognitive behavioral therapy (VR-CBT) Cognitive behavioral therapy (CBT) without VR (control group) Screening: At the screening sessions, patients' medical history is obtained, as well as their alcohol intake over the past 30 days recorded via Timeline Follow-Back (TLFB). Patients are also asked about previous alcohol dependence treatment and general information about psychosocial factors incl. education, work, marital status, and functional level using Global Assessment of functioning (GAF). In addition, alcohol-related problems are assessed using the Alcohol Users Identification Test (AUDIT), abstinence using the Clinical Institute Withdrawal Assessment of Alcohol Scale Revised (CIWA-Ar), intake of other drugs using the Drug User Identification Test (DUDIT), and alcohol craving using the Penn Alcohol Craving Scale (PACS). The Becks questionnaires, Depression Inventory 2 (BDI-II) and Beck's Anxiety Inventory (BAI), are included to assess the degree of anxiety and depression, and in addition, tests of mental function are performed using the Screening for Cognitive Impairment in Psychiatry (SCIP). Intervention: Included participants will in collaboration with their therapist schedule a standard course of treatment based on national guidelines from health authorities. After inclusion, participants are randomized to either: 14 sessions of VR-CBT (Group A) 14 sessions of CBT without VR (Group B, control group) The participants in group A are exposed to VR-simulated high-risk situations filmed in a restaurant, a pub, at home, at a party or at the supermarket, to trigger alcohol cravings and other high-risk induced reactions of which the participants are subsequently trained to handle by trained therapists using CBT-based techniques. The participants in group B receive the same treatment without VR exposure. The will be 4 weeks of weekly-biweekly treatment, followed by 20-21 weeks of treatment every 2-3 weeks, which is in line with the standard treatment in the Novaví outpatient clinics. The intervention deviates from standard treatment, as none of the participants receive pharmaceutical alcohol treatment during the treatment period (6 months) except for abstinence treatment if needed. Randomization and blinding: After screening a patient (ensuring that all inclusion criteria and no exclusion criteria are met) the patient is included. Participants are randomly allocated to either VR-CBT og CBT, 51 participants in each group. Randomization takes place in REDCap, which is a secure web application for building and managing surveys and databases. Age, sex and alcohol consumption are stratified at the time of inclusion ('heavy drinking days' and alcohol consumption - evaluated by TLFB). The technical setup of the randomization tool is performed in close collaboration with an expert in statistics, which ensures correct functionality before starting the experiment. After randomization, the therapist ensures that the participant receives the correct treatment and performs the alcohol craving assessment during each VR-CBT session unblinded using visual analog score (VAS). The study staff conducting the remaining data collections and the entire data analysis remain blinded until the database is opened at the end of the study. In situations where it is necessary to break the blind, it is possible to change the user rights in REDCap and gain access to the randomization tools. With the randomization tools, it is possible to detect the treatment (VR-CBT or CBT) based on study ID and all activities performed in REDCap are registered in the program. Follow-up: Each participant must attend a follow-up visit 3, 6, and 12 months from inclusion, where data collection will take place using the before mentioned questionnaires. The follow-up visit will be approx. 1 hour. Statistical analysis: All statistical analyzes are performed using the intention-to-treat principle, where all patients who have become randomized and has received a minimum of 1 session of VR-CBT (group A) or CBT without VR (group B), is included in the analysis. Missing data are implemented through the multiple imputation method and the analyzes are performed in the program "R" with alpha = 0.05 and 2-sided test. All continuous effect measures are analyzed using ANOVA from baseline to most recent measurement, and categorical data are analyzed using chi2 analysis. All data distributions will be assessed for normality by visual inspection of histogram and by Q-Q plots. If data is not normally distributed, log transformation is performed, and if this is not successful, non-parametric testing is used.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Dependence, in Remission, Addiction, Alcohol
Keywords
Alcohol, Addiction, Virtual Reality, Exposure Therapy, Cognitive Behavioral Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
single-blinded, randomized, controlled
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
102 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Virtual Reality Cognitive Behavioral Therapy (VRCBT)
Arm Type
Experimental
Arm Description
The 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.
Arm Title
Cognitive Behavioral Therapy (CBT)
Arm Type
Active Comparator
Arm Description
CBT 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.
Intervention Type
Behavioral
Intervention Name(s)
Virtual Reality Cognitive Behavioral Therapy (CRAVR)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
CBT
Intervention Description
The active comparator receives 14 conventional cognitive behavioral therapy sessions with
Primary Outcome Measure Information:
Title
Reduction in total alcohol consumption
Description
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.
Time Frame
Baseline, 6 months, 9 months, 12 months
Secondary Outcome Measure Information:
Title
Change in heavy drinking days
Description
Based on the past 30 days of alcohol consumption using time line follow-back (TLFB), heavy drinking days are evaluated. 1 heavy drinking day consists of alcohol consumption exceeding 60/48 grams for men and women respectively.
Time Frame
Baseline, 6 months, 9 months, 12 months
Title
Change in Alcohol Users Identification Test (AUDIT) score
Description
Screening for excessive drinking. Higher score = worse outcome
Time Frame
Baseline, 6 months, 9 months, 12 months
Title
Change in Drug User Identification Test (DUDIT) score
Description
Identification of individuals with drug-related problems. Higher score = worse outcome
Time Frame
Baseline, 6 months, 9 months, 12 months
Title
Change in Penn Alcohol Craving Scale (PACS) score
Description
Assessing alcohol craving. Higher score = worse outcome
Time Frame
Baseline, 6 months, 9 months, 12 months
Title
Screening for Cognitive Impairment in Psychiatry (SCIP) score
Description
The 20 minute test is a scale developed for screening cognitive deficits. Higher score = better outcome
Time Frame
Baseline, 6 months, 9 months, 12 months
Title
Change in Global Assessment of functioning (GAF) score
Description
GAF measures to what degree a person's symptoms affect their daily functioning on a scale of 0 to 100. Higher score = better outcome
Time Frame
Baseline, 6 months, 9 months, 12 months
Title
Becks Anxiety Inventory (BAI) score
Description
Measures the severity of anxiety. Higher score = worse outcome
Time Frame
Baseline, 6 months, 9 months, 12 months
Title
Becks Depression Inventory 2 (BDI-II) score
Description
Measures the severity of depression. Higher score = worse outcome
Time Frame
Baseline, 6 months, 9 months, 12 months
Title
Simulator Sickness Questionnaire (SSQ)
Description
Measures whether participants experience symptoms of simulator sickness while in Virtual Reality. Higher score = worse outcome
Time Frame
Each of the 14 treatment sessions over 6 months
Title
VR-induced craving on a visual analog scale (VAS)
Description
For each of the 6 VR-scenes, craving is evaluated before, during and after exposure as well as at the end of the therapy session
Time Frame
Each of the 14 treatment sessions over 6 months
Title
Alcohol withdrawal symptoms
Description
Alcohol withdrawal symptoms are evaluated at inclusion. Higher score = worse outcome
Time Frame
Evaluated at inclusion
Title
Qualitative assessment
Description
15 patients and 5 therapists will be asked about advantages and disadvantages of using virtual reality
Time Frame
After completion of a full treatment period of 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anders Fink-Jensen, MD, DMSc
Phone
+45 22755843
Email
anders.fink-jensen@regionh.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Daniel Thaysen Petersen, MD
Phone
+4528777938
Email
daniel.thaysen.petersen@regionh.dk
Facility Information:
Facility Name
Novavi ambulatorierne
City
Copenhagen
State/Province
Frederiksberg
ZIP/Postal Code
2000
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Signe W. Düring, MD, PhD
Email
SDUR@novavi.dk

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Virtual Reality-Assisted Cognitive Behavioral Therapy for Alcohol Dependence (CRAVR)

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