Technology Assisted Motivational Interviewing

Not Applicable

Not yet recruiting

• Conditions: Smoking; Smoking Cessation

• Registration Number: NCT06713603
• Lead Sponsor: University of California, San Francisco

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-10-30
• Study First Submitted QC: 2024-11-27
• Study First Posted: 2024-12-03
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-06
• Last Update Posted: 2025-05-08
• Study Start: 2025-08-15
• Primary Completion: 2027-05-31
• Study Completion: 2027-05-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 440

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Biochemical verification of smoking abstinence	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 Outcome Measures

Name	Time	Method
Self reported smoking abstinence	3-month	Self-reported point prevalence abstinence (PPA) from smoking at 3-month
Smoking reduction	Baseline, 3-month, 6-month	Self reported smoking reduction (# cigs, \>50% reductions, and # quit attempts). Change = (score at time point - score at baseline)
Readiness to quit	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)
Smoking cessation outcome expectations	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)
Self-efficacy	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)
Chatbot engagement and usage	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)
Digital Health Literacy survey	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)
AHC Screening Tool	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)
Bayliss Disease Burden	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)
PHQ-8	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)
Perceived Stress Scale	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)

Trial Locations

Locations (2)

San Francisco General Hospital; 🇺🇸 San Francisco, California, United States

UCSF Adult Primary Care Mt. Zion Clinic; 🇺🇸 San Francisco, California, United States