Virtual Reality Cue Exposurefor the Relapse Prevention of Tobacco Consumption

Interventionnal and Randomized Study Measuring Virtual Reality Cue Exposure for the Relapse Prevention of Tobacco Consumption Versus Cognitive and Behavioral Approaches Therapy

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

Study Overview

• Status: Completed
• Conditions: Chronic Tabagism
• Intervention / Treatment: Other: virtual reality exposure treatment; Other: cognitive and behavioral approaches therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Marseille, France, 13009
    • Assistance Publique Hopitaux de Marseille

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Epilepsy
• Psychiatic desease
• Dementia

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: virtual reality exposure therapy (VRET)	Other: virtual reality exposure treatment
Experimental: cognitive and behavioral approaches therapy without VRET	Other: cognitive and behavioral approaches therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
evaluate the abstinence of tobacco consumption	The primary outcome measure is represented by the efficiency which will be defined in success / failure. The success is estimated at 6 months, from the abstinence of the patient. The abstinence is defined by the total absence of tobacco consumption	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
assess the impact of this treatment strategy on depression	depression wil be assess by Beck Depression Inventory - BDI scale	12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
assess the impact of this treatment strategy on quality of life	quality of life will be assess by SF 12 questionnaire	12 months

Collaborators and Investigators

• Sponsor: Assistance Publique Hopitaux De Marseille
• Investigators: Principal Investigator: Eric Malbos, MD, Assistance Publique Hopitaux de Marseille

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 5, 2014
• Primary Completion (Actual): September 26, 2022
• Study Completion (Actual): May 23, 2023

Study Registration Dates

• First Submitted: July 25, 2014
• First Submitted That Met QC Criteria: July 29, 2014
• First Posted (Estimated): July 31, 2014

Study Record Updates

• Last Update Posted (Actual): May 25, 2023
• Last Update Submitted That Met QC Criteria: May 23, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Recurrence
• Other Study ID Numbers: 2013-A01253-42