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?

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.

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.

Is digital coaching for smoking cessation safe for humans?

The research articles reviewed do not provide specific safety data for digital coaching interventions like TAMI Coach for smoking cessation, but they generally suggest that digital interventions for smoking cessation are feasible and acceptable to participants. ^{1 2 3 4 5}

How is the TAMI Coach treatment for smoking cessation different from other treatments?

TAMI Coach is unique because it offers digital coaching, similar to a 'life coach', providing personalized and interactive guidance through the quitting process. Unlike traditional methods, it uses scheduled email reminders to encourage repeated use, making it a more engaging and supportive option for smokers trying to quit. ^{5 6 7 8 9}

What data supports the effectiveness of the treatment TAMI Coach for smoking cessation?

The study on the Pare de Fumar Conosco software shows that digital tools can increase engagement in smoking cessation programs, suggesting that similar digital coaching treatments like TAMI Coach might also be effective in helping people quit smoking. ^{10 11 12 13 14}

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

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]

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]

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]

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]

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]

Citations

1. England pubmed.ncbi.nlm.nih.gov

Happy ending: a randomized controlled trial of a digital multi-media smoking cessation intervention. [2022]

2. England 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. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Effectiveness of a smoking cessation decision-making electronic tool (Pare de Fumar Conosco): A randomized clinical trial. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Improving smoking cessation counseling using a point-of-care health intervention tool (IT): from the Virginia Practice Support and Research Network (VaPSRN). [2022]

5. Ireland pubmed.ncbi.nlm.nih.gov

Delivery of smoking cessation treatment via live chat: An analysis of client-centered coaching skills and behavior change techniques. [2022]

6. England 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@). [2020]

7. England pubmed.ncbi.nlm.nih.gov

Analysing user-reported data for enhancement of SmokefreeTXT: a national text message smoking cessation intervention. [2018]

8. England pubmed.ncbi.nlm.nih.gov

Internet-based intervention for smoking cessation (StopAdvisor) in people with low and high socioeconomic status: a randomised controlled trial. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Pilot trial of QuitBet: A digital social game that pays you to stop smoking. [2023]

10. Canada 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. [2023]

11. United States pubmed.ncbi.nlm.nih.gov

Smart devices and a future of hybrid tobacco cessation programs. [2017]

12. Canada pubmed.ncbi.nlm.nih.gov

Effect of adding a virtual community (bulletin board) to smokefree.gov: randomized controlled trial. [2022]

13. Canada pubmed.ncbi.nlm.nih.gov

Patterns of use of an automated interactive personalized coaching program for smoking cessation. [2022]

14. Canada pubmed.ncbi.nlm.nih.gov

The development of the tobacco tactics website. [2021]