评估技术辅助动机访谈（TAMI）聊天机器人戒烟效果的随机临床试验方案

IF 1.9 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials Pub Date : 2025-12-01 Epub Date: 2025-10-22 DOI:10.1016/j.cct.2025.108111

Brian Borsari , Meredith C. Meacham , Ahson Saiyed , Tatyana Kanzaveli , Maksim Tsvetovat , Jing Cheng , Anita S. Hargrave-Bouagnon , Isaac A. Mirzadegan , Faris Omeragic , John Layton , Jason Satterfield

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引用次数: 0

摘要

目前的项目建立在我们成功的试点工作基础上，开发了一个技术辅助动机访谈（TAMI）聊天机器人和戒烟教练。TAMI是一种高度可扩展且易于获取的数字指导干预措施，可促进改变的准备，提供引人注目且易于获取的戒烟工具，并制定量身定制的戒烟计划，解决治疗开始和维持的社会障碍。方法采用生成式人工智能，结合患者和专家的反馈，在随机对照试验前对TAMI聊天机器人和相关数字架构进行优化。由此产生的“TAMI 2.0”将在随机对照试验中使用，通过添加一个嵌套的第二个聊天机器人来提供基于证据的戒烟工具的教育，以及第三个嵌套的聊天机器人来建立患者的自我效能，从而进一步支持戒烟。TAMI 2.0的有效性将通过一项为期6个月的平行双臂随机对照试验来确定，该试验将TAMI 2.0与强化常规护理进行比较。从初级保健诊所招募的吸烟成人（目标N = 440）将随机分为(1)TAMI 2.0组或(2)常规护理组（UC）。主要结果将是生物化学验证的6个月时7天点流行戒烟，3个月时二级，自我报告的时间点。其他结果将包括戒烟准备、减少吸烟、戒烟结果预期、吸烟自我效能以及治疗开始和维持的变化。结论如果TAMI 2.0是一种有效的戒烟工具，那么这种全自动的、以患者为中心的聊天机器人可以扩展到所有社区，大大提高了覆盖面和可及性。NCT # NCT06713603

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Protocol for a randomized clinical trial to evaluate the effectiveness of a technology-assisted motivational interviewing (TAMI) chatbot on smoking cessation

Background

The current project builds on our successful pilot work to develop a Technology-Assisted Motivational Interviewing (TAMI) chatbot and tobacco smoking cessation coach. TAMI is a highly scalable and easily accessible digital-coaching intervention that promotes readiness to change, provides compelling and accessible smoking cessation tools, and develops a tailored quit plan addressing social barriers to treatment initiation and sustainment.

Methods

The TAMI chatbot and associated digital architecture were optimized prior to the RCT using generative AI and incorporating feedback from both patients and experts. The resulting “TAMI 2.0” to be used in the RCT further supports smoking cessation by adding a nested, second chatbot that delivers education about evidence-based cessation tools, and a third nested chatbot that builds patient self-efficacy. The effectiveness of TAMI 2.0 will be determined by a 6-month, parallel 2-arm RCT comparing TAMI 2.0 to enhanced usual care. Adults who smoke (Target N = 440) recruited from primary care clinics will be randomized to (1) TAMI 2.0 or (2) usual care (UC). The primary outcome will be biochemically verified 7-day point prevalence abstinence from tobacco at 6 months with a secondary, self-reported, timepoint at 3 months. Other outcomes will include changes in readiness for cessation, smoking reduction, cessation outcome expectancies, smoking self-efficacy, and treatment initiation and sustainment.

Conclusions

If TAMI 2.0 is found to be an effective smoking cessation tool, this fully automated, patient-centered chatbot could be scaled to all communities greatly improving reach and access. NCT# NCT06713603

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来源期刊

Contemporary clinical trials 医学-药学

CiteScore

3.70

自引率

4.50%

发文量

281

审稿时长

44 days

期刊介绍： Contemporary Clinical Trials is an international peer reviewed journal that publishes manuscripts pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from disciplines including medicine, biostatistics, epidemiology, computer science, management science, behavioural science, pharmaceutical science, and bioethics. Full-length papers and short communications not exceeding 1,500 words, as well as systemic reviews of clinical trials and methodologies will be published. Perspectives/commentaries on current issues and the impact of clinical trials on the practice of medicine and health policy are also welcome.