Virtual reality cue exposure for the relapse prevention of tobacco ă consumption: a study protocol for a randomized controlled trial

Background: Successful interventions have been developed for smoking ă cessation, but the success of smoking relapse prevention interventions ă has been limited. In particular, cognitive behavioural therapy (CBT) has ă been hampered by a high relapse rate. Because relapses can be due to the ă presence of conditions associated with tobacco consumption (such as ă drinking in bars with friends), virtual reality exposure therapy (VRET) ă can generate synthetic environments that represent risk situations for ă the patient in the context of relapse prevention. The primary objective ă of this study is to evaluate the effectiveness of CBT coupled with VRET, ă in comparison to CBT alone, in the prevention of smoking relapse. The ă secondary objectives are to assess the impact of CBT coupled with VRET ă on anxiety, depression, quality of life, self-esteem and addictive ă comorbidities (such as alcohol, cannabis, and gambling). A third ă objective examines the feasibility and acceptability of VR use ă considering elements such as presence, cybersickness and number of ă patients who complete the VRET program. ă Method/design: The present study is a 14-month (2 months of therapy ă followed by 12 months of follow-up), prospective, comparative, ă randomized and open clinical trial, involving two parallel groups (CBT ă coupled with VRET versus CBT alone). The primary outcome is the ă proportion of individuals with tobacco abstinence at 6 months after the ă end of the therapy. Abstinence is defined by the total absence of ă tobacco consumption assessed during a post-test interview and with an ă apparatus that measures the carbon monoxide levels expired. A total of ă 60 individuals per group will be included. ă Discussion: This study is the first to examine the efficacy of CBT ă coupled with VRET in the prevention of smoking relapse. Because VRET is ă simple to use and has a low cost, this interactive therapeutic method ă might be easily implemented in clinical practice if the study confirms ă its efficacy.