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Virtual Reality Cue Exposurefor the Relapse Prevention of Tobacco Consumption

Primary Purpose

Chronic Tabagism

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
virtual reality exposure treatment
cognitive and behavioral approaches therapy
Sponsored by
Assistance Publique Hopitaux De Marseille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Chronic Tabagism

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Epilepsy
  • Psychiatic desease
  • Dementia

Sites / Locations

  • Assistance Publique Hopitaux de Marseille

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

virtual reality exposure therapy (VRET)

cognitive and behavioral approaches therapy without VRET

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

assess the impact of this treatment strategy on depression
depression wil be assess by Beck Depression Inventory - BDI scale

Full Information

First Posted
July 25, 2014
Last Updated
May 23, 2023
Sponsor
Assistance Publique Hopitaux De Marseille
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1. Study Identification

Unique Protocol Identification Number
NCT02205060
Brief Title
Virtual Reality Cue Exposurefor the Relapse Prevention of Tobacco Consumption
Official Title
Interventionnal and Randomized Study Measuring Virtual Reality Cue Exposure for the Relapse Prevention of Tobacco Consumption Versus Cognitive and Behavioral Approaches Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
August 5, 2014 (Actual)
Primary Completion Date
September 26, 2022 (Actual)
Study Completion Date
May 23, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Tabagism

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
virtual reality exposure therapy (VRET)
Arm Type
Experimental
Arm Title
cognitive and behavioral approaches therapy without VRET
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
virtual reality exposure treatment
Intervention Type
Other
Intervention Name(s)
cognitive and behavioral approaches therapy
Primary Outcome Measure Information:
Title
evaluate the abstinence of tobacco consumption
Description
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
Time Frame
12 months
Secondary Outcome Measure Information:
Title
assess the impact of this treatment strategy on depression
Description
depression wil be assess by Beck Depression Inventory - BDI scale
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
assess the impact of this treatment strategy on quality of life
Description
quality of life will be assess by SF 12 questionnaire
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Smoking withdrawal for at least 1 week Age more than 18 years Exclusion Criteria: Epilepsy Psychiatic desease Dementia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Malbos, MD
Organizational Affiliation
Assistance Publique Hopitaux De Marseille
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assistance Publique Hopitaux de Marseille
City
Marseille
ZIP/Postal Code
13009
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
26892001
Citation
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.
Results Reference
derived

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Virtual Reality Cue Exposurefor the Relapse Prevention of Tobacco Consumption

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