Giovancarli Camille, Malbos Eric, Baumstarck Karine, Parola Nathalie, Pélissier Marie-Florence, Lançon Christophe, Auquier Pascal, Boyer Laurent
Department of Psychiatry, La Conception University Hospital, 13005, Marseille, France.
Aix-Marseille University, EA 3279 - Public Health, Chronic Diseases and Quality of Life - Research Unit, 13005, Marseille, France.
Trials. 2016 Feb 19;17:96. doi: 10.1186/s13063-016-1224-5.
Successful interventions have been developed for smoking cessation, but the success of smoking relapse prevention interventions has been limited. In particular, cognitive behavioural therapy (CBT) has been hampered by a high relapse rate. Because relapses can be due to the presence of conditions associated with tobacco consumption (such as drinking in bars with friends), virtual reality exposure therapy (VRET) can generate synthetic environments that represent risk situations for the patient in the context of relapse prevention. The primary objective of this study is to evaluate the effectiveness of CBT coupled with VRET, in comparison to CBT alone, in the prevention of smoking relapse. The secondary objectives are to assess the impact of CBT coupled with VRET on anxiety, depression, quality of life, self-esteem and addictive comorbidities (such as alcohol, cannabis, and gambling). A third objective examines the feasibility and acceptability of VR use considering elements such as presence, cybersickness and number of patients who complete the VRET program.
METHOD/DESIGN: The present study is a 14-month (2 months of therapy followed by 12 months of follow-up), prospective, comparative, randomized and open clinical trial, involving two parallel groups (CBT coupled with VRET versus CBT alone). The primary outcome is the proportion of individuals with tobacco abstinence at 6 months after the end of the therapy. Abstinence is defined by the total absence of tobacco consumption assessed during a post-test interview and with an apparatus that measures the carbon monoxide levels expired. A total of 60 individuals per group will be included.
This study is the first to examine the efficacy of CBT coupled with VRET in the prevention of smoking relapse. Because VRET is simple to use and has a low cost, this interactive therapeutic method might be easily implemented in clinical practice if the study confirms its efficacy.
ClinicalTrials.gov Identifier: NCT02205060 (registered 25 July 2014).
已开发出成功的戒烟干预措施，但预防吸烟复发干预措施的成效有限。尤其是认知行为疗法（CBT）一直受到高复发率的阻碍。由于复发可能归因于与烟草消费相关的情况（例如与朋友在酒吧喝酒），虚拟现实暴露疗法（VRET）可以生成模拟环境，在预防复发的背景下呈现患者面临的风险情境。本研究的主要目的是评估与单独使用CBT相比，CBT联合VRET在预防吸烟复发方面的有效性。次要目的是评估CBT联合VRET对焦虑、抑郁、生活质量、自尊和成瘾共病（如酒精、大麻和赌博）的影响。第三个目的是考虑诸如临场感、晕动症和完成VRET计划的患者数量等因素，研究VR使用的可行性和可接受性。
方法/设计：本研究是一项为期14个月（2个月治疗期，随后12个月随访期）的前瞻性、比较性、随机开放临床试验，涉及两个平行组（CBT联合VRET组与单独CBT组）。主要结局是治疗结束后6个月时戒烟个体的比例。戒烟定义为在测试后访谈期间以及使用测量呼出一氧化碳水平的仪器评估时完全没有烟草消费。每组将纳入60名个体。
本研究首次考察了CBT联合VRET预防吸烟复发的疗效。由于VRET使用简便且成本较低，如果本研究证实其疗效，这种交互式治疗方法可能很容易在临床实践中实施。
ClinicalTrials.gov标识符：NCT02205060（2014年7月25日注册）。
