Clinical trial NCT06713603: Technology Assisted Motivational Interviewing
Official title: Technology Assisted Motivational Interviewing Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Smoking
Smoking Cessation
Keywords: smoking
quit smoking
motivational interviewing
chatbot
cessation
coach
motivation
quit plan
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2024-12-03
Enrollment: 440
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Subjects will be randomized into intervention or usual care.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Biochemical verification of smoking abstinence
timeFrame: 6-month
Secondary outcomes:
measure: Self reported smoking abstinence
timeFrame: 3-month
measure: Smoking reduction
timeFrame: Baseline, 3-month, 6-month
measure: Readiness to quit
timeFrame: Baseline, 3-month, 6-month
measure: Smoking cessation outcome expectations
timeFrame: Baseline, 3-month, 6-month
measure: Self-efficacy
timeFrame: Baseline, 3-month, 6-month
measure: Chatbot engagement and usage
timeFrame: Baseline, 3-month, 6-month
measure: Digital Health Literacy survey
timeFrame: Baseline, 3-month, 6-month
measure: AHC Screening Tool
timeFrame: Baseline, 3-month, 6-month
measure: Bayliss Disease Burden
timeFrame: Baseline, 3-month, 6-month
measure: PHQ-8
timeFrame: Baseline, 3-month, 6-month
measure: Perceived Stress Scale
timeFrame: Baseline, 3-month, 6-month
Other outcomes:
measure: Demographics
timeFrame: Baseline, 6-month
measure: User experience and satisfaction
timeFrame: Baseline, 6-month
measure: Treatment barriers/facilitators
timeFrame: 6-month
Locations:
city: San Francisco
country: United States
facility: San Francisco General Hospital
state: California
city: San Francisco
country: United States
facility: UCSF Adult Primary Care Mt. Zion Clinic
state: California
Study officials:
affiliation: University of California, San Francisco
name: Jason Satterfield, PhD
role: PRINCIPAL_INVESTIGATOR
References: