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NCT Number: NCT06713603

Technology Assisted Motivational Interviewing

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

San Francisco General Hospital, San Francisco, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Current participation in a smoking cessation program
  • Current use of Nicotine Replacement Therapy or smoking cessation pharmacotherapy
  • Cognitive impairment that would preclude informed consent

Treatment and study plan

TAMI Coach

Behavioral

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.

Primary outcomes

  1. Biochemical verification of smoking abstinence

    Time frame: 6-month

    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.

Secondary outcomes

  1. Self reported smoking abstinence

    Time frame: 3-month

    Self-reported point prevalence abstinence (PPA) from smoking at 3-month

  2. Smoking reduction

    Time frame: Baseline, 3-month, 6-month

    Self reported smoking reduction (# cigs, >50% reductions, and # quit attempts). Change = (score at time point - score at baseline)

  3. Readiness to quit

    Time frame: Baseline, 3-month, 6-month

    Self reported changes in readiness to quit, and treatment initiation and sustainment. Possible scores range from 1 (not at all) to 10 (totally ready). Change = (score at time point - score at baseline)

  4. Smoking cessation outcome expectations

    Time frame: Baseline, 3-month, 6-month

    Self reported smoking cessation outcome expectations measuring how serious would the health consequences be if the participant developed a smoking-related disease. Possible scores range from 1 (Not at all) to 5 (Extremely serious). Change = (score at time point - score at baseline)

  5. Self-efficacy

    Time frame: Baseline, 3-month, 6-month

    The Smoking Self-Efficacy Questionnaire (SEQ-12) is a validated, self reported 12-item instrument that measures the confidence of current and former smokers in their ability to abstain from smoking in certain social or emotional situations. The SEQ-12 has two subscales measuring confidence in ability to refrain from smoking when facing internal stimuli (e.g., feeling depressed) and external stimuli (e.g., being with smokers). Possible scores range from 1 (not at all sure) to 5 (absolutely sure). The scores for each question are added together. A higher score indicates greater self-efficacy. Change = (score at time point - score at baseline)

  6. Chatbot engagement and usage

    Time frame: Baseline, 3-month, 6-month

    The Mobile App Rating Scale is a validated, self reported instrument measuring app quality across four dimensions: engagement, functionality, aesthetics and information quality. Possible scores range from 1 (not at all useful) to 4 (very useful. Change = (score at time point - score at baseline)

  7. Digital Health Literacy survey

    Time frame: Baseline, 3-month, 6-month

    The Digital Health Literacy instrument is a validated, self-reported 8-item instrument measuring digital health literacy in general adult populations. Possible scores range from 1 (strongly disagree) to 5 (strongly agree). Change = (score at time point - score at baseline)

  8. AHC Screening Tool

    Time frame: Baseline, 3-month, 6-month

    The Accountable Health Communities screening tool is a validated, self reported 10-item instrument assessing social needs. Change = (score at time point - score at baseline)

  9. Bayliss Disease Burden

    Time frame: Baseline, 3-month, 6-month

    Bayliss Disease Burden

    The Bayliss Disease Burden Morbidity Assessment is a validated, self-reported instrument serving as a subjective measure of comorbidity that incorporates an assessment of disease severity. Possible scores range from 1 (not at all) to 5 (a lot). Disease burden is defined as the number of self-identified comorbid conditions weighted by the degree to which each interfered with their daily activities. Change = (score at time point - score at baseline)

  10. PHQ-8

    Time frame: Baseline, 3-month, 6-month

    The Personal Health Questionnaire Depression Scale is a validated, self-reported 8-item instrument assessing symptoms of depression. Possible scores range from 0 (not at all) to 3 (nearly every day). The scores for each question are added together. A higher score indicates greater depression. Change = (score at time point - score at baseline)

  11. Perceived Stress Scale

    Time frame: Baseline, 3-month, 6-month

    The Perceived Stress Scale is a validated, self-reported 10-item instrument assessing how stressful a person finds their life to be. Possible scores range from 0 (never) to 4 (very often). The scores for each question are added together. A higher score indicates greater perceived stress. Change = (score at time point - score at baseline)

Other outcomes

  1. Demographics

    Time frame: Baseline, 6-month

    Self reported demographics

  2. User experience and satisfaction

    Time frame: Baseline, 6-month

    The Working Alliance Inventory is a validated, self-reported 12 item instrument measuring three key aspects of the therapeutic alliance: (a) agreement on the tasks of therapy, (b) agreement on the goals of therapy and (c) development of an affective bond. Possible scores range from 1 (seldom) to 5 (always).

    Change = (score at time point - score at baseline)

  3. Treatment barriers/facilitators

    Time frame: 6-month

    Open feedback on treatment barriers/facilitators via 1:1 Exit Interviews

Study contacts

Contact information is provided by the study sponsor or research team.

Faris Omeragic, BS

CONTACT

[email protected]

303-918-9233

Jason Satterfield, PhD

CONTACT

[email protected]

415-353-2104

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Official study title

Technology Assisted Motivational Interviewing Randomized Controlled Trial

Acronym: TAMI

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Dec 3, 2024
Registry last updated
Oct 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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