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

BACKGROUND: 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 co...

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Autores principales: Giovancarli, Camille, Malbos, Eric, Baumstarck, Karine, Parola, Nathalie, Pélissier, Marie-Florence, Lançon, Christophe, Auquier, Pascal, Boyer, Laurent
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2016
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4759851/
https://www.ncbi.nlm.nih.gov/pubmed/26892001
http://dx.doi.org/10.1186/s13063-016-1224-5
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author Giovancarli, Camille
Malbos, Eric
Baumstarck, Karine
Parola, Nathalie
Pélissier, Marie-Florence
Lançon, Christophe
Auquier, Pascal
Boyer, Laurent
author_facet Giovancarli, Camille
Malbos, Eric
Baumstarck, Karine
Parola, Nathalie
Pélissier, Marie-Florence
Lançon, Christophe
Auquier, Pascal
Boyer, Laurent
author_sort Giovancarli, Camille
collection PubMed
description BACKGROUND: 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. DISCUSSION: 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. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02205060 (registered 25 July 2014). ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s13063-016-1224-5) contains supplementary material, which is available to authorized users.
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spelling pubmed-47598512016-02-20 Virtual reality cue exposure for the relapse prevention of tobacco consumption: a study protocol for a randomized controlled trial Giovancarli, Camille Malbos, Eric Baumstarck, Karine Parola, Nathalie Pélissier, Marie-Florence Lançon, Christophe Auquier, Pascal Boyer, Laurent Trials Study Protocol BACKGROUND: 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. DISCUSSION: 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. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02205060 (registered 25 July 2014). ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s13063-016-1224-5) contains supplementary material, which is available to authorized users. BioMed Central 2016-02-19 /pmc/articles/PMC4759851/ /pubmed/26892001 http://dx.doi.org/10.1186/s13063-016-1224-5 Text en © Giovancarli et al. 2016 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
spellingShingle Study Protocol
Giovancarli, Camille
Malbos, Eric
Baumstarck, Karine
Parola, Nathalie
Pélissier, Marie-Florence
Lançon, Christophe
Auquier, Pascal
Boyer, Laurent
Virtual reality cue exposure for the relapse prevention of tobacco consumption: a study protocol for a randomized controlled trial
title Virtual reality cue exposure for the relapse prevention of tobacco consumption: a study protocol for a randomized controlled trial
title_full Virtual reality cue exposure for the relapse prevention of tobacco consumption: a study protocol for a randomized controlled trial
title_fullStr Virtual reality cue exposure for the relapse prevention of tobacco consumption: a study protocol for a randomized controlled trial
title_full_unstemmed Virtual reality cue exposure for the relapse prevention of tobacco consumption: a study protocol for a randomized controlled trial
title_short Virtual reality cue exposure for the relapse prevention of tobacco consumption: a study protocol for a randomized controlled trial
title_sort virtual reality cue exposure for the relapse prevention of tobacco consumption: a study protocol for a randomized controlled trial
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4759851/
https://www.ncbi.nlm.nih.gov/pubmed/26892001
http://dx.doi.org/10.1186/s13063-016-1224-5
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