Digital Coaching for Smoking Cessation

(TAMI Trial)

Recruiting at 1 trial location

Overseen By Jason Satterfield, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Francisco

Must not be taking: Nicotine replacement, Cessation pharmacotherapy

Disqualifiers: Cognitive impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

440 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a digital coaching tool designed to help people quit smoking by boosting motivation and addressing social barriers. The main treatment, TAMI Coach, is an interactive chatbot that encourages users to prepare for quitting and develop a personalized plan. Participants in the experimental group will receive regular support and reminders, while a control group will receive standard educational materials. This trial suits individuals who smoke at least one cigarette daily, are proficient in English, and have access to a digital device like a phone or laptop. As an unphased trial, this study offers an opportunity to contribute to innovative research that could help many people quit smoking.

Will I have to stop taking my current medications?

The trial requires that you are not currently using Nicotine Replacement Therapy or smoking cessation medications. If you are using these, you would need to stop before participating.

What prior data suggests that the TAMI Coach is safe for smoking cessation?

Research has shown that the TAMI Coach, a chatbot designed to help people quit smoking, has been tested for effectiveness and safety. The TAMI Coach is a digital tool that uses motivational interviewing to encourage and support the decision to quit smoking.

Regarding safety, studies have not identified any major safety issues with the TAMI Coach. As a digital program that does not involve medication, it typically has fewer side effects. Users have not reported any serious problems, indicating it is generally well-tolerated.

As a technology-based tool, the TAMI Coach's success depends on user interaction and perceived helpfulness and support. This makes it a lower-risk option compared to treatments involving medication or physical procedures. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about TAMI Coach for smoking cessation because it offers a unique, digital approach to quitting smoking. Unlike traditional methods such as nicotine replacement therapies, medications like varenicline, or counseling, TAMI Coach uses a web-based Motivational Interviewing chatbot that interacts with users over a 6-month period. This chatbot not only provides personalized quit plans and boosts self-confidence but also remembers past conversations to tailor its guidance, much like a human clinician. Additionally, it offers ongoing support through text messages, helping users tackle common challenges leading up to their quit date. This innovative use of technology could make smoking cessation more accessible and engaging, potentially increasing success rates.

What evidence suggests that the TAMI Coach is effective for smoking cessation?

Studies have shown that the TAMI Coach, a digital chatbot, can effectively help people quit smoking. In this trial, participants in the Technology Assisted Motivational Interviewing (TAMI) arm will interact with this tool, which uses a special method to boost motivation and address social challenges that make quitting difficult. Early research suggests that TAMI helps users by creating personalized quit plans and offering ongoing support. It also increases readiness to quit by remembering past conversations and building confidence. While more data is needed, initial findings are promising for those seeking to quit smoking with digital support. ^{1 2 3 4 6}

Who Is on the Research Team?

Jason Satterfield, PhD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

This trial is for individuals who are currently smoking and interested in quitting. They should be willing to engage with a digital coach via chatbot to increase their motivation and create a personalized plan to stop smoking. The details about specific inclusion or exclusion criteria are not provided.

Inclusion Criteria

Have a digital device (phone, laptop, tablet)

Able to participate for 6-month trial

A current Primary Care Provider patient

Exclusion Criteria

I am currently using methods or medications to help me stop smoking.

I am able to understand and give informed consent.

Current participation in a smoking cessation program

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants interact with the TAMI chatbot for smoking cessation over a 6-month period, receiving up to two text messages per week to initiate conversations.

6 months

Virtual interactions via chatbot

Follow-up

Participants are monitored for smoking abstinence and other outcomes at 3 and 6 months.

6 months

What Are the Treatments Tested in This Trial?

Interventions

• TAMI Coach

Trial Overview The study tests a Technology Assisted Motivational Interviewing (TAMI) Coach, which is a chatbot designed to help smokers quit by boosting their readiness to change, educating them on cessation tools in multiple languages, and helping develop tailored plans that consider social barriers.

How Is the Trial Designed?

Group I: Technology Assisted Motivational Interviewing (TAMI) Experimental Treatment 1 Intervention

Individuals 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.

Group II: Usual Care Active Control 1 Intervention

Individuals 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.

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

Published Research Related to This Trial

The Tobacco Tactics website, designed for veterans, underwent usability testing and received positive feedback, leading to over 27 modifications to enhance user experience, with 83% of participants finding it enjoyable and easy to navigate.

In a pilot study, veterans using the Tobacco Tactics website along with nicotine replacement therapy achieved a 40% abstinence rate at 30 days, compared to only 13% in the control group, indicating its potential effectiveness in helping veterans quit smoking.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The development of the tobacco tactics website. Duffy, SA., Fowler, KE., Flanagan, PS., et al.[2021]

A fully automated digital smoking cessation intervention, called Happy Ending, significantly improved long-term abstinence rates among participants (22.3%) compared to a control group using a self-help booklet (13.1%) in a study of 396 smokers over 54 weeks.

The treatment group also showed better adherence to nicotine replacement therapy and higher self-efficacy after quitting, suggesting that digital interventions can effectively support behavior change in smoking cessation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Happy ending: a randomized controlled trial of a digital multi-media smoking cessation intervention. Brendryen, H., Kraft, P.[2022]

Among 311,567 users of the iCoach app for smoking cessation, 26,785 steady users were identified, with more intensive app use linked to higher rates of smoking cessation, improved quitting stages, and increased self-efficacy over time.

The most significant improvements in smoking-related outcomes were observed within the first 3 months of app use, particularly among older users and women, who were more likely to engage with the app intensively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of the Smoking Cessation App Ex-Smokers iCoach and Associations With Smoking-Related Outcomes Over Time in a Large Sample of European Smokers: Retrospective Observational Study. Mansour, MB., Busschers, WB., Crone, MR., et al.[2023]

The QuitCoach program, designed for smoking cessation, has been used by over 28,000 individuals, with 91% planning to quit within 30 days, indicating its effectiveness in reaching smokers who are motivated to quit.

While many users only visit the site once, those who return—especially women, older smokers, and those using pharmacotherapy—are more likely to successfully quit, highlighting the need for strategies to encourage ongoing engagement with the program.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patterns of use of an automated interactive personalized coaching program for smoking cessation. Balmford, J., Borland, R., Benda, P.[2022]

This study is a randomized controlled trial involving 460 smokers, assessing the effectiveness of a chat-bot intervention for smoking cessation compared to usual treatment, with a focus on long-term nicotine abstinence validated by chemical testing at 6 months.

The research aims to provide evidence on the effectiveness of technology-based interventions in smoking cessation, potentially improving accessibility and adherence to treatment while ensuring patient safety through scientific validation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a chat-bot for the adult population to quit smoking: protocol of a pragmatic clinical trial in primary care (Dejal@). Avila-Tomas, JF., Olano-Espinosa, E., Minué-Lorenzo, C., et al.[2020]

In a study of 18,080 adults using the SmokefreeTXT program, over half completed the 42-day smoking cessation treatment, with a 12.9% abstinence rate among those who finished the program.

The study revealed that while initial engagement was promising, long-term abstinence rates dropped significantly, highlighting the need for improved participant retention strategies and support at critical time points to enhance smoking cessation success.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analysing user-reported data for enhancement of SmokefreeTXT: a national text message smoking cessation intervention. Augustson, E., Cole-Lewis, H., Sanders, A., et al.[2018]

The NRT2Quit smartphone app showed preliminary evidence of improving short-term smoking cessation rates and adherence to nicotine replacement therapy (NRT), with a biochemically verified quit rate of 25% in the intervention group compared to 8% in the control group, although the results were not statistically significant due to low participant numbers.

Participants using the NRT2Quit app logged in more frequently and were more likely to use NRT at follow-up (100% vs. 28.6%), suggesting that the app may enhance engagement and support for smokers trying to quit.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pragmatic randomised trial of a smartphone app (NRT2Quit) to improve effectiveness of nicotine replacement therapy in a quit attempt by improving medication adherence: results of a prematurely terminated study. Herbec, A., Brown, J., Shahab, L., et al.[2023]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/41135811/

Protocol for a randomized clinical trial to evaluate the ... Conclusions: If TAMI 2.0 is found to be an effective smoking cessation tool, this fully automated, patient-centered chatbot could be scaled to ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1877050922009644

Technology-Assisted Motivational Interviewing This study developed the Technology Assisted Motivational Interviewing Coach (TAMI), a digital conversational agent that incorporates machine learning models.

3. trialx.com trialx.com/clinical-trials/listings/325347/technology-assisted-motivational-interviewing/

Technology Assisted Motivational Interviewing Able to participate for 6-month trial. Exclusion Criteria: Current participation in a smoking cessation program; Current use of Nicotine ...

4. researchgate.net researchgate.net/publication/396796144_Protocol_for_a_randomized_clinical_trial_to_evaluate_the_effectiveness_of_a_technology-assisted_motivational_interviewing_TAMI_chatbot_on_smoking_cessation

Protocol for a randomized clinical trial to evaluate the ... Protocol for a randomized clinical trial to evaluate the effectiveness of a technology-assisted motivational interviewing (TAMI) chatbot on ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1551714425003052

Protocol for a randomized clinical trial to evaluate the ... Protocol for a randomized clinical trial to evaluate the effectiveness of a technology-assisted motivational interviewing (TAMI) chatbot on smoking cessation.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4691359/

Technology-delivered adaptations of motivational ... The aims of this paper were to describe and evaluate the methods and efficacy of technology-delivered motivational interviewing interventions (TAMIs).