Virtual Reality Cue Exposurefor the Relapse Prevention of Tobacco Consumption

NCT ID: NCT02205060

Last Updated: 2023-05-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-05
• Study Completion Date: 2023-05-23

Brief Summary

The therapeutic efficacy of virtual reality has been validated for the treatment of various mental disorders ,smoking behavior is the first preventable cause of death in developed countries However, after a successful withdrawal, a high relapse rate (between 40 and 70%)has been observed, which emphasize the urgent need to implement new strategies. Virtual reality cue exposure for the relapse of tobacco consumption

Detailed Description

Smoking behavior is the first preventable cause of death in developed countries (World.Health.Organisation, 2009).It is reinforced by the nicotine found in cigarettes. This compound is responsible for a notable dependence effect. As a result of mass consumption, this subsequent addiction of tobacco is a psychiatric disorder that represents a significant public health issue. In France, the latest health survey INEPS (2010) retrieved an increase of daily smokers with a prevalence of 28.7% among adults over 15 years (Beck et al., 2010). However, after a successful withdrawal, a high relapse rate (between 40 and 70%) (Hatsukami et al., 2008) has been observed, which emphasize the urgent need to implement new strategies. These relapses are due to the presence of conditions associated with tobacco consumption (drinking in bars or restaurant, coffee break at the workplace, etc.). (Garcia-Rodriguez et al., 2012). These same situations are difficult to reconstruct in the framework of a hospital or an office.

Virtual reality has been introduced in the field of psychiatry as a method entitled virtual reality exposure therapy (VRET). Virtual reality allows patients to interact with a virtual environment (Riva and Wiederhold, 2002). This media can therefore help to generate synthetic environments which represent risk situations for the patient in the context of relapse prevention.

The therapeutic efficacy of virtual reality has been validated for the treatment of various mental disorders (phobias, agoraphobia and post-traumatic stress, etc.) (Powers and Emmelkamp, 2008). These studies have shown that VRET was at least as effective as traditional CBT while providing immersive and controllable virtual environments. During the recent years, its scope has expanded to tobacco addiction (Garcia-Rodriguez et al., 2012), although this area of research remains in experimental field and requires carrying out ad-hoc clinical trials. Indeed, compared to the standard treatment, VRET offers various advantages for cue exposure, such as controlled environments and complex, dynamic interactive three-dimensional situations (virtual Bars, office and artificial smokers computerized restaurants, etc.). It features the possibility of gradually exposing the patient to situations considered to be of a "high risk of relapse" in the confidentiality of an office and repeating these procedures as often as necessary. Lastly it allows the therapist to guide the patient in real time helping them to modify emotions and addiction related cognitions.

Conditions

Chronic Tabagism

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

virtual reality exposure therapy (VRET)

Group Type: EXPERIMENTAL

virtual reality exposure treatment

Intervention Type: OTHER

cognitive and behavioral approaches therapy without VRET

Group Type: EXPERIMENTAL

cognitive and behavioral approaches therapy

Intervention Type: OTHER

Interventions

virtual reality exposure treatment

Intervention Type: OTHER

cognitive and behavioral approaches therapy

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Smoking withdrawal for at least 1 week
• Age more than 18 years

Exclusion Criteria

• Epilepsy
• Psychiatic desease
• Dementia

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eric Malbos, MD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique Hopitaux De Marseille

Locations

Assistance Publique Hopitaux de Marseille

Marseille, , France

Countries

France

References

Giovancarli C, Malbos E, Baumstarck K, Parola N, Pelissier MF, Lancon C, Auquier P, Boyer L. Virtual reality cue exposure for the relapse prevention of tobacco consumption: a study protocol for a randomized controlled trial. Trials. 2016 Feb 19;17:96. doi: 10.1186/s13063-016-1224-5.

Reference Type: DERIVED

PMID: 26892001 (View on PubMed)

Other Identifiers

2013-A01253-42

Identifier Type: -

Identifier Source: org_study_id