Digital mindfulness training program description.

Background
Tobacco use is one of the leading causes of preventable disease and death worldwide. Despite the availability of evidence-based pharmacological treatments, only a small number of individuals with tobacco use disorder achieve long-term abstinence after smoking cessation. This highlights the need to enhance existing interventions. In this protocol, we describe our single-center mixed-method trial, HowToMind, conducted in Dijon, France. This trial aims to investigate the usability and acceptability of a digital mindfulness-based intervention designed to complement standard smoking cessation treatment to potentiate its effects.
Methods
We will include 60 adults seeking treatment for tobacco use disorder, as defined by DSM-5 criteria, who wish to quit smoking and own a smartphone. All participants will receive a combination of transdermal and oral nicotine replacement therapy and will be introduced to an eHealth app that provides a digital equivalent of an 8-week mindfulness training program. The acceptability of the initial version of our app will be assessed based on usage frequency, and usability will be evaluated using the Mobile App Rating Scale (French version). A participatory approach will be employed through focus groups conducted at the end of the 8 weeks of app use, aimed at co-constructing the final version of the app based on participant feedback.
Discussion
Our pilot mixed-method trial seeks to explore the usability and acceptability of our app, making necessary adjustments to its content and functionality based on participant feedback before its implementation in a large randomized controlled trial assessing the app’s potential to enhance the effects of standard treatment.
Trial registration
ClinicalTrials.gov, NCT06500117.

背景
烟草使用是全球可预防疾病与死亡的首要诱因之一。尽管已有循证药理学治疗手段，但仅少数烟草使用障碍患者在戒烟后能够实现长期戒断。这一现状凸显了优化现有干预措施的必要性。本研究方案将介绍在法国第戎开展的单中心混合方法试验HowToMind。该试验旨在探究一款数字化正念干预工具的可用性与可接受性，该工具旨在作为标准戒烟治疗的辅助手段，以强化其干预效果。

方法
本研究将纳入60名符合《精神障碍诊断与统计手册第五版（DSM-5）》标准、希望戒烟且拥有智能手机的成人烟草使用障碍患者。所有受试者均将接受透皮与口服尼古丁替代疗法联合治疗，并将被引导使用一款电子健康应用（eHealth app），该应用可提供等效于8周正念训练计划的数字化内容。本应用初始版本的可接受性将通过使用频率进行评估，可用性则将采用移动应用评分量表（Mobile App Rating Scale，法语版）进行评价。在8周应用使用周期结束后，将通过焦点小组采用参与式研究方法，基于受试者反馈共同构建该应用的最终版本。

讨论
本先导性混合方法试验旨在探索该应用的可用性与可接受性，以便在开展大规模随机对照试验以评估该应用对强化标准戒烟治疗效果的潜力之前，基于受试者反馈对其内容与功能进行必要调整。

试验注册
该试验已在ClinicalTrials.gov注册，编号为NCT06500117。