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

Addiction, Alcohol Clinical Trial

Official title:

Virtual Reality-Assisted Cognitive Behavioral Therapy for Alcohol Dependence: A Pilot Study (CRAVR-Pilot)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04990765
• Other study ID #: CRAVRPILOT
• Status: Recruiting
• Phase: Phase 2
• Start date: May 11, 2021
• Est. completion date: October 20, 2021

Study information

• Verified date: July 2021
• Source: Psychiatric Centre Rigshospitalet
• Contact: Anders Fink-Jensen, MD, DMSc
• Phone: +45 22755843
• Email: anders.fink-jensen[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Pilot study rational:

Prior to the major randomized clinical trial, a total of 10 participants with alcohol dependence are included in a pilot trial. This is done to examine the feasibility of the following elements:

i) adherence to the intervention and drop-outs ii) the therapists' theoretical and practical abilities to use the virtual reality (VR) equipment iii) the time spent on virtual reality during the therapy session iv) the need for technical support v) the collaboration in the project group and vi) the participants' experience of virtual reality-assisted cognitive behavioral therapy (VRCBT).

During the pilot trial, patients receive standardized alcohol treatment for alcohol dependence at the Novavis outpatient clinics based on national guidelines from health authorities. Three of the therapy sessions contain VR-CBT.

Recruitment of participants:

Patients seeking alcohol treatment in the Novaví outpatient clinics are informed orally and in writing about the research project, and if they are interested, an information meeting is booked. If patients exhibit abstinence, these are treated prior to a possible information meeting by doctors and nurses in Novaví. If the patient wishes to participate and meets the inclusion criteria, informed consent is obtained, and screening is conducted using questionnaires described below.

Screening:

At the screening sessions, patiens medical history is obtained, as well as patients' alcohol intake over the past 30 days is 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), 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:

1. 3 sessions of VR-CBT (Group A)

2. CBT without VR (Group B, control group)

The participants in group A are exposed to VR-simulated high-risk situations filmed in a restaurant to trigger alcohol cravings 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. There will be weekly therapy sessions of approx. 1 hour for 3 weeks.

The intervention deviates from standard treatment, as none of the participants receive pharmaceutical alcohol treatment during the treatment period except for abstinence treatment if needed.

Randomization and blinding:

After screening the 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, 5 participants in each group. 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 are blinded, until the database is opened at the end of the study.

Follow-up:

Each patient must attend a follow-up visit 1 week and 1 month after the last session (session 3), 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 VRCBT (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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: October 20, 2021
• Est. primary completion date: October 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Addiction, Alcohol
• Alcohol Dependence, in Remission
• Alcoholism
• Behavior, Addictive

Intervention

Behavioral:
• Virtual Reality Cognitive Behavioral Therapy (CRAVR)
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.
• CBT
The active comparator receives 3 conventional cognitive behavioral therapy sessions with 1 week intervals.

Locations

Country	Name	City	State
Denmark	Novavi ambulatorierne	Copenhagen	Frederiksberg

Sponsors (2)

Lead Sponsor	Collaborator
Psychiatric Centre Rigshospitalet	The Novavì outpatient clinics, Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Reduction 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.	Baseline,1 week and 1 month follow-up
Secondary	Reduction in Alcohol Users Identification Test (AUDIT) score	Screening for excessive drinking. Higher score = worse outcome	Baseline, 1 week and 1 month follow-up
Secondary	Reduction in Drug User Identification Test (DUDIT) score	Identification of individuals with drug-related problems. Higher score = worse outcome	Baseline, 1 week and 1 month follow-up
Secondary	Reduction in Penn Alcohol Craving Scale (PACS) score	Assessing alcohol craving. Higher score = worse outcome	Baseline, 1 week and 1 month follow-up
Secondary	Screening for Cognitive Impairment in Psychiatry (SCIP) score	The 20 minute test is a scale developed for screening cognitive deficits. Higher score = better outcome	Baseline, 1 week and 1 month follow-up
Secondary	Reduction 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	Baseline, 1 week and 1 month follow-up
Secondary	Becks Anxiety Inventory (BAI) score	Measures the severity of anxiety. Higher score = worse outcome	For baseline to 1 week and 1 month follow-up
Secondary	Becks Depression Inventory 2 (BDI-II) score	Measures the severity of depression. Higher score = worse outcome	For baseline to 1 week and 1 month follow-up
Secondary	Simulator Sickness Questionnaire (SSQ)	Measures whether participants experience symptoms of simulator sickness while in Virtual Reality. Higher score = worse outcome	Evaluated in each session
Secondary	VR-induced craving on a visual analog scale (VAS)	For each of the 6 VR-scenes, craving is evaluated before, during and after exposure.	Evaluated in each session
Secondary	VR-induced thoughts, emotions, physiological reactions and behavior		Evaluated in each session