Clinical trial NCT04610931: Study of the Effectiveness of a Virtual Reality Treatment in the Management of Smoking Cessation
Official title: Study of the Effectiveness of a Virtual Reality Treatment in the Management of Smoking Cessation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Tobacco Use Cessation
Keywords: Addiction
Tobacco
Virtual Reality Exposure Therapy
Cognitive Behaviour Therapy
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
Collaborators: name: National Cancer Institute, France
First posted: 2020-11-02
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: TREATMENT

Brief summary: 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: 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).

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of patients who quit smoking
timeFrame: Day 43
measure: Percentage of patients who quit smoking
timeFrame: Day 136
measure: Percentage of patients who quit smoking
timeFrame: Day 229
measure: Percentage of patients who quit smoking
timeFrame: Day 408
Secondary outcomes:
measure: smoking decreasing
timeFrame: Day 229, Day 408
measure: Craving score
timeFrame: Day 1, Day 43, Day 74, Day 136, Day 229, Day 408
measure: Needing score
timeFrame: Day 1, Day 43, Day 74, Day 136, Day 229, Day 408
measure: e-health score
timeFrame: Day 1, Day 43
measure: Follow-up of all virtual reality sessions
timeFrame: Day 43
measure: Relapse rate
timeFrame: Day 1, Day 43, Day 74, Day 136, Day 229, Day 408
measure: Level of anxiety and depression
timeFrame: Day 1, Day 43, Day 74, Day 136, Day 229, Day 408
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: Clermont-Ferrand University Hospital
state: Auvergne
Study officials:
References: