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

Borsari B, Meacham MC, Saiyed A, Kanzaveli T, Tsvetovat M, Cheng J, Hargrave-Bouagnon AS, Mirzadegan IA, Omeragic F, Layton J, Satterfield J. Protocol for a randomized clinical trial to evaluate the effectiveness of a technology-assisted motivational interviewing (TAMI) chatbot on smoking cessation. Contemporary clinical trials. 2025 Dec 1; 159:108111, DOI: 10.1016/j.cct.2025.108111.

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Abstract:

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.