Smoking, Smoking Cessation
Conditions
Keywords
smoking, quit smoking, motivational interviewing, chatbot, cessation, coach, motivation, quit plan
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.
Interventions
BEHAVIORALTAMI Coach
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.
Sponsors
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Subjects will be randomized into intervention or usual care.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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) |
| 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) |
| 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) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Treatment barriers/facilitators | 6-month | Open feedback on treatment barriers/facilitators via 1:1 Exit Interviews |
| Demographics | Baseline, 6-month | Self reported demographics |
| User experience and satisfaction | 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) |
Countries
United States
Contacts
Primary ContactJason Satterfield, PhD
Backup ContactFaris Omeragic, BS
Outcome results
None listed