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临床试验/NCT02205060
NCT02205060已完成不适用

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

Assistance Publique Hopitaux De Marseille2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2014年8月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
2
主要终点
evaluate the abstinence of tobacco consumption

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • Psychiatic desease

结局指标

主要结局

evaluate the abstinence of tobacco consumption

时间窗: 12 months

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

次要结局

  • assess the impact of this treatment strategy on depression(12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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