Study of the Effectiveness of a Virtual Reality Treatment in the Management of Smoking Cessation

Study Overview
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Brief Summary
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Tobacco is an addiction with serious consequences: somatic, psychiatric... The number of requests for treatment for tobacco addiction is gradually increasing from year to year, but conventional treatments have limited effectiveness. New tools such as virtual reality could be used in this treatment. We propose to create a virtual reality program based on the analysis of high-risk relapse situations. The investigator will then evaluate the effect of this cybertherapy on patients' relapse time and their desire to smoke.

Detailed Description
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Smoking is the leading cause of morbidity and mortality, making it one of the most serious public health problems in the world. The majority of smokers would like to stop smoking and the number of smokers seeking treatment has increased by 25% between 2017 and 2018 in France. Indeed, many effective interventions have been developed to stop smoking, but many patients continue to relapse after a quit attempt. Only 10% to 30% achieve long-term abstinence and the majority relapse. The therapeutic approach to addiction is based on a bio-psycho-social model. It aims to limit the runaway of subcortical processes (the cause of craving) via a medicinal approach and to strengthen the cortical control mechanisms via a psychotherapeutic approach. As far as psychotherapeutic approaches are concerned, they seek to obtain a modification of cognitions and emotions related to tobacco through, for example, a relearning of the management of the product mediated by evocation or exposure. This may involve, for example, the repeated presentation (or evocation) of a signal (e.g. a place of consumption...), previously linked to consumption but in the absence of a reinforcer (product consumption). Most addiction remediation therapies have been developed and practiced with imagination (the patient is asked to think of stimulating situations) but they are difficult to control (because the patient's imagination can be more or less large) and are rarely used with situations that induce consumption. In this context the use of a 3Dimension (3D) tool, which allows a controlled and progressive exposure without confrontation, seems an interesting perspective. Virtual reality is recognized as a tool in the fields of neuroscience and psychology. It allows a patient-controlled exposure to complex, dynamic and three-dimensional stimuli. Thus, virtual reality has logically been proposed as a tool in exposure therapies and its benefit has been measured in substance dependencies (Hone-Blanchet et al 2014). Since 2000, several researchers have successfully used virtual reality applications in addictions, but there is little data on objective evaluations of the effectiveness of cybertherapy in the treatment of tobacco addiction, particularly in association with the two reference treatments for smoking cessation that are nicotine substitution associated with cognitive behavioural therapy. For tobacco, the results are heterogeneous and did not take into account the different factors for maintaining tobacco use (Lee et al 2004, Choi et al 2011, Park et al 2014). Virtual therapy appears to be more effective when combined with other relapse prevention techniques such as cognitive behavioural therapy (CBT).

Official Title
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Study of the Effectiveness of a Virtual Reality Treatment in the Management of Smoking Cessation

Conditions
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Tobacco Use Cessation

Intervention / Treatment
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* Behavioral: Virtual Reality-Enhanced Cognitive Behavioral Therapy (VR-CBT)
* Behavioral: cognitive behavior therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female between 18 and 75 years of age Who smokes 10 or more cigarettes per day in the month prior to inclusion Who wants to quit smoking Who has a diagnosis of a smoking disorder with craving criteria according to DSM 5 criteria Who is able to speak and read French Who is covered by the French national health insurance system Who has a signed consent form Exclusion Criteria: Subjects with decompensated psychiatric co-morbidities (DSM 5) or unstable organic disease Subjects at serious suicide risk Subjects with other substance use disorders (DSM 5) Problems that interact with 3D exposure: tendency to dissociation; interceptive phobias (panic attacks and hypochondria...); severe dizziness. Cognitive problems that limit or prevent the ability to implement coping strategies or the management of emotions or stimuli and disabilities to complete the questionnaires Subjects belonging to a protected population such as pregnant women, breastfeeding women, guardians Subjects deprived of liberty by judicial or administrative decision, subject to psychiatric treatment under duress, minor subject, or unable to express their consent Who refuses to participate

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Random-sized block randomization, stratified on the number of previous relapses, will be performed for the inclusions of patients within the cybertherapy group or Treatment as usual group
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cybertherapy<br>use of cybertherapy (6 sessions) in addition to cognitive behavioral therapy (6 sessions) + pharmacological treatment | Behavioral: Virtual Reality-Enhanced Cognitive Behavioral Therapy (VR-CBT)<br>* Participants are smokers seeking treatment. Patients will be randomized into one of the 2 intervention groups. In all cases, patients will receive nicotine replacement therapy. The second physician in charge of the usual tobacco monitoring will adjust the dosage. Subjects in the usual treatment group will receive 6 weekly individual cognitive behavior therapy sessions lead by a psychologist. The content of CBT is similar in both groups. Subjects in the Virtual Reality group will receive 6 weekly individual CBT sessions followed by 6 virtual therapy sessions. Virtual therapy consists of exposing the patient to 3D situations considered to cause a high risk of smoking relapse and aiming to reduce signal reactivity by extinction. At each session, a neutral exposure will be given at the beginning to facilitate immersion and emergence of the session with a duration determined according to the sensitivity of each patient. Exposure is stopped when the craving approaches the baseline level.<br>|
| Active Comparator: Treatment as usual<br>Treatment as usual is a cognitive behavioral therapy (6 sessions) + pharmacological treatment | Behavioral: cognitive behavior therapy<br>* Participants are smokers seeking treatment. Patients will be randomized into one of the 2 intervention groups. In all cases, patients will receive nicotine replacement therapy. The second physician in charge of the usual tobacco monitoring will adjust the dosage. Subjects in the usual treatment group will receive 6 weekly individual cognitive behavior therapy sessions lead by a psychologist. The content of CBT is similar in both groups.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients who quit smoking | Comparison of proportion of patients who quit smoking after 6 weeks after intervention in the 2 arms (declarative status verified by measurement of carbon monoxide level in the expired air) and until one year. | Day 43 | 
| Percentage of patients who quit smoking | Comparison of proportion of patients who quit smoking after 6 weeks after intervention in the 2 arms (declarative status verified by measurement of carbon monoxide level in the expired air) and until one year. | Day 136 | 
| Percentage of patients who quit smoking | Comparison of proportion of patients who quit smoking after 6 weeks after intervention in the 2 arms (declarative status verified by measurement of carbon monoxide level in the expired air) and until one year. | Day 229 | 
| Percentage of patients who quit smoking | Comparison of proportion of patients who quit smoking after 6 weeks after intervention in the 2 arms (declarative status verified by measurement of carbon monoxide level in the expired air) and until one year. | Day 408 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| smoking decreasing | Comparison between arms of mean/median number of cigarette smoke per day (declarative status and measurement of carbon monoxide level in the expired air) | Day 229, Day 408 | 
| Craving score | evaluation of craving score with Tabacco Craving Questionnary sort Form questionnaire (7 to 84; 7 no craving and 84 highest craving) ; comparison between arms at different endpoints | Day 1, Day 43, Day 74, Day 136, Day 229, Day 408 | 
| Needing score | It is evaluated with an analogical visual scale (1 to 10; 1 the lowest 10 the highest); comparison between arms at different endpoints | Day 1, Day 43, Day 74, Day 136, Day 229, Day 408 | 
| e-health score | It is evaluated with disease simulation questionnaire (French Speach Spatial en Quality -SSQ-vf- questionnaire)(/16) | Day 1, Day 43 | 
| Follow-up of all virtual reality sessions | Follow-up of all virtual reality sessions is assessed at 6 weeks post-inclusion | Day 43 | 
| Relapse rate | Relapse rate is the percentage of participants who are abstinent at the end of treatment and who relapse during the follow-up period; comparison between arms at different endpoints | Day 1, Day 43, Day 74, Day 136, Day 229, Day 408 | 
| Level of anxiety and depression | It is evaluated with the Hospital Anxiety and Depression - HAD scale (1 to 21; 1 no anxiety and depression , 21 highest symptoms); comparison between arms at different endpoints | Day 1, Day 43, Day 74, Day 136, Day 229, Day 408 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Addiction, Tobacco, Virtual Reality Exposure Therapy, Cognitive Behaviour Therapy