Technology Assisted Motivational Interviewing
TAMI
2 other identifiers
interventional
440
1 country
2
Brief Summary
Building on our successful pilot work to develop a Motivational Interviewing (MI)-capable chatbot and cessation coach, the investigators propose to address the problems of intrinsic motivation and social barriers to smoking cessation by evaluating a highly scalable and easily accessible digital-coaching intervention that 1) promotes readiness to change using a technology-assisted MI (TAMI) chatbot, 2) provides compelling and accessible multilingual education about smoking cessation tools, and 3) develops a tailored quit plan addressing social barriers to treatment initiation and sustainment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2025
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 30, 2024
CompletedFirst Posted
Study publicly available on registry
December 3, 2024
CompletedStudy Start
First participant enrolled
September 22, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 31, 2027
October 23, 2025
October 1, 2025
1.7 years
October 30, 2024
October 21, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Biochemical verification of smoking abstinence
The primary clinical outcome is 7-day point prevalence abstinence (PPA) from smoking at 6-months. Abstinence will be biochemically verified with salivary cotinine. To maximize the validity of our primary abstinence outcome, the investigators will require any participant in who reports abstinence at 6-month to complete salivary cotinine bio-verification using a mailed, commercially available test kit. Participants will be instructed to electronically send two photos - one of them giving a saliva sample and the other with the test results. Recent reviews of biochemical verification strategies have validated this methodology. People with at least 10 ng/ml cotinine in their saliva will be considered smokers. The investigators will ask participants to report any Nicotine Replacement Therapy use or vaping to identify false positives.
6-month
Secondary Outcomes (11)
Self reported smoking abstinence
3-month
Smoking reduction
Baseline, 3-month, 6-month
Readiness to quit
Baseline, 3-month, 6-month
Smoking cessation outcome expectations
Baseline, 3-month, 6-month
Self-efficacy
Baseline, 3-month, 6-month
- +6 more secondary outcomes
Other Outcomes (3)
Demographics
Baseline, 6-month
User experience and satisfaction
Baseline, 6-month
Treatment barriers/facilitators
6-month
Study Arms (2)
Technology Assisted Motivational Interviewing (TAMI)
EXPERIMENTALIndividuals randomized to TAMI will interact with the fully automated, web-based MI-chatbot for the 6-month study period. Patients who continue to smoke will receive up to two text messages per week with the chatbot URL link to initiate additional conversations always beginning with an assessment of readiness to change but "remembering" prior conversations much like a clinician. Individuals in the preparation stage will move directly to EBP education, tailoring a quit plan and boosting both self-efficacy and outcome expectancies. Patients with sufficient confidence will be encouraged to set a quit date. Patients will be encouraged to include their PCP and/or state quitline. TAMI will provide support proximal to the quit date including guidance through common obstacles. TAMI will check back to assess treatment initiation, treatment sustainment (and/or cessation), or relapse. Patients who are unable to quit (or who relapse) will be encouraged to restart conversations with TAMI.
Usual Care
NO INTERVENTIONIndividuals randomized to the Usual Care (UC) condition will receive a detailed educational handout on the health risks associated with smoking and information on Evidence Based Practice's (EBP) for cessation using the standard "Kick-It California" materials. Additional materials and referral resources regarding depression, stress, and other common barriers will be provided to all UC participants. Any UC individual can choose to quit at any time but they will not have access to TAMI. While this is not an "active" treatment condition, the handout and recurring assessments (at 3 and 6mo) may serve as reminders about the importance of quitting and may assist with finding support for co-occurring conditions or social needs.
Interventions
The investigators address the problems of intrinsic motivation, Evidence Based Practice (EBP) education, and referral tailoring using a digital-coaching intervention that 1) promotes readiness to change, 2) educates and builds confidence about EBP's, and 3) creates a tailored quit plan sensitive to social obstacles and needs.
Eligibility Criteria
You may qualify if:
- A current Primary Care Provider patient
- Age 18 or older
- Smoke at least 1 cigarette per day for the past 7 consecutive days (and at least 100 lifetime)
- Have a digital device (phone, laptop, tablet)
- Moderately proficient in English
- Able to participate for 6-month trial
You may not qualify if:
- Current participation in a smoking cessation program
- Current use of Nicotine Replacement Therapy or smoking cessation pharmacotherapy
- Cognitive impairment that would preclude informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
San Francisco General Hospital
San Francisco, California, 94110, United States
UCSF Adult Primary Care Mt. Zion Clinic
San Francisco, California, 94115, United States
Related Publications (1)
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. Contemp Clin Trials. 2025 Dec;159:108111. doi: 10.1016/j.cct.2025.108111. Epub 2025 Oct 22.
PMID: 41135811DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jason Satterfield, PhD
University of California, San Francisco
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 30, 2024
First Posted
December 3, 2024
Study Start
September 22, 2025
Primary Completion (Estimated)
May 31, 2027
Study Completion (Estimated)
May 31, 2027
Last Updated
October 23, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will not share
This project is funded by the UC Tobacco-Related Disease Research Program (TRDRP) and will use the data sharing platform required for that consortia.