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

NCT04610931 | Completed

• 1 other identifier: RBHP 2020 BROUSSE
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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.

Conditions

Tobacco Use Cessation

Keywords

Addiction; Tobacco; Virtual Reality Exposure Therapy; Cognitive Behaviour Therapy

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (7)

• smoking decreasing

  Day 229, Day 408

• Craving score

  Day 1, Day 43, Day 74, Day 136, Day 229, Day 408

• Needing score

  Day 1, Day 43, Day 74, Day 136, Day 229, Day 408

• e-health score

  Day 1, Day 43

• Follow-up of all virtual reality sessions

  Day 43

Study Arms (2)

Cybertherapy

EXPERIMENTAL

use of cybertherapy (6 sessions) in addition to cognitive behavioral therapy (6 sessions) + pharmacological treatment

Behavioral: Virtual Reality-Enhanced Cognitive Behavioral Therapy (VR-CBT)

Treatment as usual

ACTIVE COMPARATOR

Treatment as usual is a cognitive behavioral therapy (6 sessions) + pharmacological treatment

Behavioral: cognitive behavior therapy

Interventions

Virtual Reality-Enhanced Cognitive Behavioral Therapy (VR-CBT) BEHAVIORAL

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.

Cybertherapy

cognitive behavior therapy BEHAVIORAL

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.

Treatment as usual

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female between 18 and 75 years of age
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead
• National Cancer Institute, France: collaborator

Study Sites (1)

Clermont-Ferrand University Hospital

Clermont-Ferrand, Auvergne, 63000, France

Location

MeSH Terms

Conditions

Tobacco Use Cessation; Behavior, Addictive

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Compulsive Behavior; Impulsive Behavior

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: October 16, 2020
• First Posted: November 2, 2020
• Study Start: September 2, 2021
• Primary Completion: January 7, 2026
• Study Completion: January 7, 2026
• Last Updated: February 4, 2026

Record last verified: 2026-02

Locations

FR (1)