PDF(Pubmed)
Abstract：
BACKGROUND: Cigarette smoking remains a leading cause of preventable illness and death, underscoring the need for effective evidence-based smoking cessation interventions. Nuumi, a novel smoking cessation program integrating a digital behavioral therapy and an electronic cigarette, may provide a solution.
OBJECTIVE: To investigate the initial efficacy, acceptability and psychological outcomes of an evidence-based smoking cessation intervention comprised of a mobile phone app and an electronic cigarette among adults who smoke and who are motivated to quit.
METHODS: A prospective 6-month single-arm mixed-methods pilot study will be conducted. Seventy adults who smoke and who are motivated to quit will be recruited via web-based advertisements and flyers. Participants receive access to an app and an electronic cigarette with pods containing nicotine for temporary use of at least 3 months. The electronic cigarette is coupled with the app via Bluetooth, allowing for tracking of patterns of use. The behavioral therapy leverages evidence-based content informed by cognitive behavioral therapy and mindfulness-informed principles. Web-based self-report surveys will be conducted at baseline, at 4 weeks, at 8 weeks, at 12 weeks, and at 24 weeks post-baseline. Semi-structured interviews will be conducted at baseline and at 12 weeks post-baseline. Primary outcomes will be self-reported 7-day point prevalence abstinence from smoking at 12 weeks and 24 weeks. Secondary outcomes will include other smoking cessation-related outcomes, psychological outcomes, and acceptability of the nuumi intervention. Descriptive analyses and within-group comparisons will be performed on the quantitative data, and content analyses will be performed on the qualitative data. Recruitment for this study started in October 2023.
CONCLUSIONS: As tobacco smoking is a leading cause of preventable morbidity and mortality, this research addresses one of the largest health burdens of our time. The results will provide insights into the initial efficacy, acceptability, and psychological outcomes of a novel mobile health intervention for smoking cessation. If successful, this pilot may generate an effective intervention supporting adults who smoke to quit smoking. The results will inform feasibility of a future randomized controlled trial. Trial Registration German Clinical Trials Register DRKS00032652, registered 09/15/2023, https://drks.de/search/de/trial/DRKS00032652 .
OBJECTIVE: To investigate the initial efficacy, acceptability and psychological outcomes of an evidence-based smoking cessation intervention comprised of a mobile phone app and an electronic cigarette among adults who smoke and who are motivated to quit.
METHODS: A prospective 6-month single-arm mixed-methods pilot study will be conducted. Seventy adults who smoke and who are motivated to quit will be recruited via web-based advertisements and flyers. Participants receive access to an app and an electronic cigarette with pods containing nicotine for temporary use of at least 3 months. The electronic cigarette is coupled with the app via Bluetooth, allowing for tracking of patterns of use. The behavioral therapy leverages evidence-based content informed by cognitive behavioral therapy and mindfulness-informed principles. Web-based self-report surveys will be conducted at baseline, at 4 weeks, at 8 weeks, at 12 weeks, and at 24 weeks post-baseline. Semi-structured interviews will be conducted at baseline and at 12 weeks post-baseline. Primary outcomes will be self-reported 7-day point prevalence abstinence from smoking at 12 weeks and 24 weeks. Secondary outcomes will include other smoking cessation-related outcomes, psychological outcomes, and acceptability of the nuumi intervention. Descriptive analyses and within-group comparisons will be performed on the quantitative data, and content analyses will be performed on the qualitative data. Recruitment for this study started in October 2023.
CONCLUSIONS: As tobacco smoking is a leading cause of preventable morbidity and mortality, this research addresses one of the largest health burdens of our time. The results will provide insights into the initial efficacy, acceptability, and psychological outcomes of a novel mobile health intervention for smoking cessation. If successful, this pilot may generate an effective intervention supporting adults who smoke to quit smoking. The results will inform feasibility of a future randomized controlled trial. Trial Registration German Clinical Trials Register DRKS00032652, registered 09/15/2023, https://drks.de/search/de/trial/DRKS00032652 .
摘要：
背景：吸烟仍然是可预防疾病和死亡的主要原因，强调需要有效的循证戒烟干预措施。努米,一个新颖的戒烟计划，整合了数字行为疗法和电子烟，可以提供一个解决方案。
目的：为了研究初始疗效，基于证据的戒烟干预措施的可接受性和心理结果，该干预措施包括一个手机应用程序和一个电子烟，适用于吸烟和有戒烟动机的成年人。
方法：将进行为期6个月的前瞻性单臂混合方法试点研究。将通过基于网络的广告和传单招募70名吸烟并有戒烟动机的成年人。参与者可以访问一个应用程序和一个含有尼古丁的电子烟，可以临时使用至少3个月。电子烟通过蓝牙与应用程序耦合，允许跟踪使用模式。行为疗法利用基于认知行为疗法和正念知情原则的循证内容。基于网络的自我报告调查将在基线进行，在4周，在8周的时候,在12周，在基线后24周。半结构化访谈将在基线和基线后12周进行。主要结果将是自我报告的7天点患病率戒烟12周和24周。次要结果将包括其他戒烟相关结果，心理结果，以及努米干预的可接受性。将对定量数据进行描述性分析和组内比较，并对定性数据进行内容分析。这项研究的招募始于2023年10月。
结论：由于吸烟是可预防的发病率和死亡率的主要原因，这项研究解决了我们这个时代最大的健康负担之一。结果将提供对初始疗效的见解，可接受性,以及新型戒烟移动健康干预的心理结果。如果成功,该飞行员可能会产生有效的干预措施，以支持吸烟的成年人戒烟。结果将告知未来随机对照试验的可行性。试验注册德国临床试验注册DRKS00032652，注册09/15/2023，https://drks。de/search/de/trial/DRKS00032652.
目的：为了研究初始疗效，基于证据的戒烟干预措施的可接受性和心理结果，该干预措施包括一个手机应用程序和一个电子烟，适用于吸烟和有戒烟动机的成年人。
方法：将进行为期6个月的前瞻性单臂混合方法试点研究。将通过基于网络的广告和传单招募70名吸烟并有戒烟动机的成年人。参与者可以访问一个应用程序和一个含有尼古丁的电子烟，可以临时使用至少3个月。电子烟通过蓝牙与应用程序耦合，允许跟踪使用模式。行为疗法利用基于认知行为疗法和正念知情原则的循证内容。基于网络的自我报告调查将在基线进行，在4周，在8周的时候,在12周，在基线后24周。半结构化访谈将在基线和基线后12周进行。主要结果将是自我报告的7天点患病率戒烟12周和24周。次要结果将包括其他戒烟相关结果，心理结果，以及努米干预的可接受性。将对定量数据进行描述性分析和组内比较，并对定性数据进行内容分析。这项研究的招募始于2023年10月。
结论：由于吸烟是可预防的发病率和死亡率的主要原因，这项研究解决了我们这个时代最大的健康负担之一。结果将提供对初始疗效的见解，可接受性,以及新型戒烟移动健康干预的心理结果。如果成功,该飞行员可能会产生有效的干预措施，以支持吸烟的成年人戒烟。结果将告知未来随机对照试验的可行性。试验注册德国临床试验注册DRKS00032652，注册09/15/2023，https://drks。de/search/de/trial/DRKS00032652.
