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 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).

Adherence to leukemia maintenance therapy: a comparative study among children, adolescents, and adults.

This study describes patient adherence to leukemia maintenance therapy and the factors associated with nonadherence, with a particular focus on the different age groups concerned. Sixty-four in-depth interviews were performed in three centers among 31 parents of children, 12 parents of adolescents, 12 adolescents, and 9 adult patients. Adherence was determined through a multimethod approach based on patient and/or parent responses to three self-administered questions and patient and/or parent interviews. The results were compared with physician evaluation of adherence. Factors explaining nonadherence were investigated in the in-depth interviews and by statistical analysis of self-administered questionnaires. Intentional nonadherence occurred rarely (4/52 patients, 8%) following poor tolerance of the maintenance therapy. Despite a high motivation to follow the maintenance therapy, repeated forgetfulness (8/52, 15%) was not rare and rarely detected by physicians. Nonadherence increased with age, but also existed among children. Outings, the administration of therapy at bedtime, the lack of monitoring, a low socioeconomic status, and the hepatic side effects of the treatment were also associated with nonadherence. Declared nonadherence of leukemia maintenance therapy is not negligible and should be screened at follow-up consultations using three simple questions.