Adapt2Quit Motivational System for Quitting Smoking

(A2Q Trial)

Recruiting at 2 trial locations

Overseen By Reem M Najjar

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Massachusetts, Worcester

Disqualifiers: Non-smokers, Minors, Pregnant, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

757 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a computer program called Adapt2Quit that sends personalized motivational texts to help socioeconomically disadvantaged smokers quit. The program uses user feedback to choose the most motivating messages.

Do I have to stop taking my current medications to join the trial?

The trial protocol does not specify whether you need to stop taking your current medications.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on smoking cessation through motivational messages, so it's unlikely that your medications would be affected.

What data supports the idea that Adapt2Quit Motivational System for Quitting Smoking is an effective treatment?

The available research does not provide specific data on the effectiveness of the Adapt2Quit Motivational System for Quitting Smoking. However, it does mention the effectiveness of another treatment, the Pathways to Change system, which is an expert system intervention for smoking cessation. This system showed cessation rates of 22 to 26% in a general population, with increasing effects over time. This suggests that expert system interventions, like Adapt2Quit, could potentially be effective in helping people quit smoking. ^{1 2 3 4 5}

What data supports the effectiveness of the Adapt2Quit treatment for quitting smoking?

The Pathways to Change system, an expert system intervention similar to Adapt2Quit, has shown success in helping people quit smoking, with cessation rates of 22 to 26%. This suggests that expert system interventions can be effective in supporting smoking cessation. ^{1 2 3 4 5}

What safety data is available for the Adapt2Quit smoking cessation treatment?

The provided research does not directly mention safety data for the Adapt2Quit treatment or its variants. The studies focus on other smoking cessation methods, such as smartphone applications, electronic cigarettes, text messaging programs, and chat-bots, but do not provide specific safety data for Adapt2Quit. ^{6 7 8 9 10}

Is the Adapt2Quit treatment a promising way to quit smoking?

The Adapt2Quit treatment seems promising because similar systems, like SmartQuit and Text2Quit, have shown success in helping people quit smoking. These systems use technology to provide support and advice, which can make quitting easier and more effective. ^{5 8 11 12 13}

How is the Adapt2Quit treatment different from other smoking cessation treatments?

The Adapt2Quit Motivational System for Quitting Smoking is unique because it likely combines personalized motivational strategies with technology to help individuals quit smoking, setting it apart from other treatments like smartphone apps or text messaging programs that focus on behavioral therapy or automated support. ^{5 8 11 12 13}

Research Team

Rajani Sadasivam, PhD

Principal Investigator

Associate Professor

Eligibility Criteria

This trial is for English-speaking adults who smoke, have had at least two clinical visits in the past year, and are socioeconomically disadvantaged. They must own a texting-enabled cell phone. Pregnant women, prisoners, those unable to consent, minors, and previous pilot study participants cannot join.

Inclusion Criteria

Active in care (at least two clinical visits in the last year)

You are currently smoking.

You are unemployed or underemployed, low income as defined by the federal poverty level guidelines, uninsured or underinsured, and/or have less than a high school education.

Exclusion Criteria

Pilot study participants

I am unable to give consent for medical procedures.

Pregnant women

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Adapt2Quit motivational messaging and quitline facilitation messaging or quitline facilitation-only messaging for 6 months

6 months

Ongoing text message interactions

Follow-up

Participants are monitored for smoking cessation outcomes, including biochemical CO verification and self-reported cessation rates

6 months post-randomization

Treatment Details

Interventions

• Adapt2Quit

Trial Overview The Adapt2Quit program is being tested against a control that only facilitates quitline use via text messages. The program sends motivational texts tailored to help users quit smoking based on their feedback on message effectiveness.

Participant Groups

Group I: Adapt2Quit Experimental Treatment 1 Intervention

These participants will receive Adapt2Quit motivational messaging and quitline facilitation messaging for 6 months.

Group II: Control Active Control 1 Intervention

These participants will receive quitline facilitation-only messaging for 6 months.

Who Is Running the Clinical Trial?

University of Massachusetts, Worcester

Lead Sponsor

Trials

372

Recruited

998,000+

Johns Hopkins University

Collaborator

Trials

2,366

Recruited

15,160,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Baystate Health

Collaborator

Trials

9

Recruited

54,500+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Findings from Research

The fidelity index developed to measure the delivery of a smoking cessation behavioral support intervention showed good reliability, indicating it can effectively assess how well providers adhere to and interact during the sessions.

Higher quality of interaction during the sessions was linked to better quit rates among participants, while strict adherence to the content was associated with lower quit rates, suggesting that the way support is delivered may be more important than simply following the content guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Measuring fidelity to behavioural support delivery for smoking cessation and its association with outcomes. Dogar, O., Boehnke, JR., Lorencatto, F., et al.[2021]

Nicotine mini-lozenges can increase smoking abstinence rates in individuals who are initially unwilling to quit, achieving a 16.7% abstinence rate when used alone.

However, when combined with reduction counseling, the effectiveness of the mini-lozenge significantly decreases, leading to a much lower abstinence rate of 4.1%, and reduction counseling itself reduces the likelihood of making a quit attempt.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating four motivation-phase intervention components for use with primary care patients unwilling to quit smoking: a randomized factorial experiment. Cook, JW., Baker, TB., Fiore, MC., et al.[2022]

In a study of 513 smokers, electronic monitoring and counseling significantly increased the use of nicotine gum, but this did not lead to higher rates of smoking abstinence.

Adherence to both the nicotine patch and gum during the first 6 weeks of a quit attempt was strongly associated with higher rates of abstinence at 1 year, suggesting that consistent use of these aids may be crucial for successful quitting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can we increase smokers' adherence to nicotine replacement therapy and does this help them quit? Schlam, TR., Cook, JW., Baker, TB., et al.[2019]

In a study of 248 hospitalized patients who smoke, 54% were found to be poorly motivated to quit, highlighting a significant challenge in smoking cessation efforts in acute care settings.

The research identified a specific group of patients—mainly men in cardiology units with low motivation and a willingness to receive support—who may benefit from targeted motivational interviewing to encourage smoking cessation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing motivation to smoking cessation in hospitalized patients. Sepúlveda-Sánchez, JM., Canca-Sánchez, JC., Rivas-Ruiz, F., et al.[2021]

The Pathways to Change (PTC) system is an effective smoking cessation intervention, achieving cessation rates of 22% to 26% in four studies, indicating its efficacy in helping smokers quit.

The intervention's effects appear to increase over time, as follow-up assessments showed larger differences in cessation rates, suggesting lasting benefits beyond the treatment period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An expert system intervention for smoking cessation. Velicer, WF., Prochaska, JO.[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 involving 409 adult daily smokers, the Text2Quit program was found to significantly aid smoking cessation primarily by enhancing psychosocial factors like self-efficacy and quitting know-how, accounting for 35% of its effectiveness.

The program's benefits were less associated with the use of additional smoking cessation resources, suggesting that the motivational support provided by Text2Quit is more crucial for helping individuals quit smoking than external treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How do text-messaging smoking cessation interventions confer benefit? A multiple mediation analysis of Text2Quit. Hoeppner, BB., Hoeppner, SS., Abroms, LC.[2018]

The revised SmartQuit 2.0 app showed high user satisfaction and receptivity, with 84% of participants satisfied and 73% willing to recommend it, significantly improving from the previous version, SmartQuit 1.0.

At the 2-month follow-up, 21% of participants achieved a 7-day quit rate, and 75% reduced their smoking frequency, indicating that while quit rates were modest, program completion (24% of participants) led to higher success rates, suggesting that engagement with the app is crucial for effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Single-arm trial of the second version of an acceptance & commitment therapy smartphone application for smoking cessation. Bricker, JB., Copeland, W., Mull, KE., et al.[2023]

In a pilot study involving 60 cigarette smokers, the use of an electronic cigarette (ECIG) alongside their regular cigarettes showed that 56.7% of participants completed the 4-week intervention, indicating feasibility for future studies.

Participants using ECIGs were more likely to attempt quitting later in the study, suggesting that modified risk tobacco products may influence quit-related motivation and behavior, although adherence to the study protocol was a challenge.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Piloting a clinical laboratory method to evaluate the influence of potential modified risk tobacco products on smokers' quit-related motivation, choice, and behavior. Ozga-Hess, JE., Felicione, NJ., Ferguson, SG., et al.[2021]

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 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 SmartQuit® app, based on Acceptance and Commitment Therapy, significantly reduced daily cigarette intake among 10 smokers in a New Zealand study, with three participants remaining smoke-free for up to 13 months after using the app.

While cravings did not show significant changes across the study phases, there was a trend towards decreasing cravings, indicating that the app may help manage cravings even if not directly reducing them.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using SmartQuit®, an Acceptance and Commitment Therapy Smartphone application, to reduce smoking intake. Singh, S., Starkey, NJ., Sargisson, RJ.[2022]

The Text2Quit program significantly increased biochemically confirmed smoking abstinence rates, with 11.1% of participants in the intervention group remaining smoke-free compared to only 5.0% in the control group, indicating a relative risk of 2.22.

Self-reported smoking abstinence was also higher in the Text2Quit group (19.9%) compared to the control group (10.0%), suggesting that the program is effective across various demographic groups, particularly among non-white participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized trial of Text2Quit: a text messaging program for smoking cessation. Abroms, LC., Boal, AL., Simmens, SJ., et al.[2022]

References

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

Measuring fidelity to behavioural support delivery for smoking cessation and its association with outcomes. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Evaluating four motivation-phase intervention components for use with primary care patients unwilling to quit smoking: a randomized factorial experiment. [2022]

3. Germany pubmed.ncbi.nlm.nih.gov

Can we increase smokers' adherence to nicotine replacement therapy and does this help them quit? [2019]

4. Spain pubmed.ncbi.nlm.nih.gov

Assessing motivation to smoking cessation in hospitalized patients. [2021]

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

An expert system intervention for smoking cessation. [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

How do text-messaging smoking cessation interventions confer benefit? A multiple mediation analysis of Text2Quit. [2018]

8. Ireland pubmed.ncbi.nlm.nih.gov

Single-arm trial of the second version of an acceptance & commitment therapy smartphone application for smoking cessation. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Piloting a clinical laboratory method to evaluate the influence of potential modified risk tobacco products on smokers' quit-related motivation, choice, and behavior. [2021]

10. England pubmed.ncbi.nlm.nih.gov

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

11. Canada pubmed.ncbi.nlm.nih.gov

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

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

Using SmartQuit®, an Acceptance and Commitment Therapy Smartphone application, to reduce smoking intake. [2022]

13. Netherlands pubmed.ncbi.nlm.nih.gov

A randomized trial of Text2Quit: a text messaging program for smoking cessation. [2022]