Smartphone Messaging Support for Smoking

Overseen By Johannes Thrul, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins Bloomberg School of Public Health

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

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 48

160 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether smartphone messages can help young adults quit smoking using either cognitive behavioral therapy (CBT) or Mindfulness/ACT techniques. The goal is to determine which type of message best aids individuals in managing the urge to smoke in real-life situations. Participants will either receive these smartphone-based intervention messages or simply track their smoking habits without additional support. Ideal candidates are 18-30 years old, smoke frequently, plan to quit soon, and own a smartphone. As an unphased trial, this study provides a unique opportunity to explore innovative methods for quitting smoking through technology.

Will I have to stop taking my current medications?

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

What prior data suggests that this smartphone-based intervention is safe for smoking cessation?

Research shows that smartphone messages can safely help people quit smoking. Studies have found that these messages provide reminders and advice to manage cravings. Importantly, no major safety issues have been reported with this method. People generally find these messages helpful in their journey to quit smoking. This evidence suggests that phone-based support is both safe and effective for quitting smoking. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this smartphone-based intervention for smoking because it offers a novel, tech-driven approach to managing smoking urges. Unlike traditional methods like nicotine replacement therapies or prescription medications, this intervention delivers Cognitive Behavioral Therapy (CBT) and Mindfulness/Acceptance and Commitment Therapy (ACT) messages directly to a user's smartphone. These messages are strategically sent based on real-time data about when and where a person is most at risk for smoking, which personalizes and enhances the support offered. This method leverages technology to provide immediate, location-specific assistance, potentially increasing its effectiveness and accessibility compared to standard treatments.

What evidence suggests that this trial's smartphone-based intervention messages could be effective for smoking cessation?

Research has shown that smartphones can aid in quitting smoking. In this trial, participants in the micro-randomized trial group will receive personalized text messages based on behavior change theories, which studies have found more effective than generic ones. Approaches like Cognitive Behavioral Therapy (CBT) and Mindfulness/Acceptance and Commitment Therapy (ACT) effectively reduce the urge to smoke. These methods teach coping strategies for cravings and promote flexible thinking. Tailored messages sent to phones can provide support during challenging times, making them a promising tool for quitting smoking, especially for young adults. Meanwhile, the EMA-only control group will not receive these intervention messages but will continue with EMA data collection. ^{3 6 7 8 9}

Who Is on the Research Team?

Johannes Thrul, PhD

Principal Investigator

Johns Hopkins Bloomberg School of Public Health

Are You a Good Fit for This Trial?

This trial is for young adults in the U.S., aged 18-30, who can read English and want to quit smoking. They must have smoked over 100 cigarettes in their lifetime and currently smoke at least once on three days each week. Participants need to own a smartphone and plan to quit within the next month.

Inclusion Criteria

I plan to quit smoking within the next 30 days.

I have smoked more than 100 cigarettes in my life and currently smoke at least once on most days.

Patients must live in the U.S.

Exclusion Criteria

Not applicable.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Ecological Momentary Assessment (EMA) Training

Participants collect EMA data for 14 days to determine high-risk situations for smoking

2 weeks

Daily EMA surveys

Intervention

Participants receive tailored CBT and Mindfulness/ACT messages triggered by geofencing of high-risk locations

4 weeks

3 geofence-triggered EMAs per day

Follow-up

Participants are monitored for changes in smoking behavior and psychological flexibility

6 months

Assessments at 45-day, 3-month, and 6-month follow-up

What Are the Treatments Tested in This Trial?

Interventions

• Smartphone-based intervention messages

Trial Overview The study tests if messages sent through smartphones using cognitive behavioral therapy (CBT) or Mindfulness/Acceptance and Commitment Therapy (ACT) help young adults stop smoking. It focuses on sending support during high-risk situations that trigger the urge to smoke.

How Is the Trial Designed?

Group I: Micro-randomized trial group Experimental Treatment 1 Intervention

The micro-randomized trial will determine if CBT and Mindfulness/ACT messages are superior to control messages in reducing the primary outcome momentary smoking urges. Based on participants' training data collected in the initial 14 days of EMA monitoring, intervention messages will be delivered during time-periods and at high-risk locations for smoking. In the intervention phase, participants will be prompted to complete 3 geofence-triggered EMAs per day for a total of 30 days. Each EMA will be followed by an intervention message and the type of message (CBT, Mindfulness/ACT, control) will be randomly selected at each time point (within-subject randomization).

Group II: EMA-only control group Active Control 1 Intervention

A total of N=80 participants will be randomized into an EMA-only control group, parallel to the micro-randomized trial intervention group. This group will conduct 14-day EMA only training phase just like the micro-randomized trial group, but will not be switched over to the intervention phase after these initial 14 days. Instead, participants will continue the EMA-only data collection procedure for an additional 30-days (analogous to the 30-day intervention phase of the micro-randomized trial). During these 30 days, the EMA-only control group will continue to receive 3 randomly prompted EMA surveys per day and an additional 3 EMA surveys triggered by smoking reports.

Smartphone-based intervention messages is already approved in United States, European Union, China, Canada, Japan, Switzerland for the following indications:

Approved in United States as Smartphone-based messaging intervention for:

• Smoking cessation

Approved in European Union as Mobile phone-based smoking cessation intervention for:

• Smoking cessation

Approved in China as Text message-based smoking cessation intervention for:

• Smoking cessation

Approved in Canada as Smartphone-based messaging intervention for:

• Smoking cessation

Approved in Japan as Mobile phone-based smoking cessation intervention for:

• Smoking cessation

Approved in Switzerland as Text message-based smoking cessation intervention for:

• Smoking cessation

Who Is Running the Clinical Trial?

Johns Hopkins Bloomberg School of Public Health

Lead Sponsor

Trials

441

Recruited

2,157,000+

Published Research Related to This Trial

Mobile phone-based smoking cessation interventions, particularly those using text messaging, significantly increase the likelihood of quitting smoking, with a risk ratio of 1.67 based on 12 studies involving six-month cessation outcomes.

Biochemical verification of quitting status in six studies showed an even higher success rate (risk ratio of 1.83), indicating that these interventions are effective, although most studies were conducted in high-income countries with established tobacco control policies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile phone-based interventions for smoking cessation. Whittaker, R., McRobbie, H., Bullen, C., et al.[2023]

A hybrid intervention combining telephone counseling and text messaging was tested on 66 hospitalized smokers in Brazil, showing a higher rate of abstinence at 1-month (25.0% vs. 9.1%) and 3-month (31.8% vs. 9.1%) follow-ups compared to a standard care group.

Participants found the text messaging helpful (80.4% approval) and the counseling session appropriate in length (95.1% approval), indicating that this approach is not only effective but also well-received, making it a promising low-cost option for smoking cessation in middle- and lower-income countries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Experimental Feasibility Study of a Hybrid Telephone Counseling/Text Messaging Intervention for Post-Discharge Cessation Support Among Hospitalized Smokers in Brazil. Cruvinel, E., Richter, KP., Colugnati, F., et al.[2020]

A smartphone app designed for smoking cessation effectively assessed real-time risk for smoking lapses and provided tailored messages, leading to greater reductions in smoking urges, stress, and cigarette availability among participants (N=59) over a 3-week period.

Messages specifically tailored to individual triggers, such as smoking urges and stress, were more effective in reducing those triggers compared to generic messages, suggesting that personalized interventions can enhance smoking cessation efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An ecological momentary intervention for smoking cessation: The associations of just-in-time, tailored messages with lapse risk factors. Hébert, ET., Stevens, EM., Frank, SG., et al.[2022]

A meta-analysis of 13 randomized controlled trials found that SMS text message interventions increased smoking cessation rates by 36% compared to control groups, indicating their effectiveness in promoting quitting.

Interventions with a 3-month follow-up showed higher efficacy than those with a 6-month follow-up, and fixed message schedules were more effective than variable ones, suggesting that the timing and consistency of messages are important for success.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of SMS Text Message Interventions for Smoking Cessation: A Meta-Analysis. Spohr, SA., Nandy, R., Gandhiraj, D., et al.[2022]

In a study involving 924 smokers using the QuitTxt program, most participants (68.9%) preferred the default messaging frequency of 4-8 texts per day, and the median duration of use was 27 days, indicating a generally positive reception of the program.

Despite some users not fully reporting their quit status, many still found QuitTxt helpful, suggesting that consistent reporting may not be crucial for the program's effectiveness in supporting smoking cessation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How do smokers use a smoking cessation text messaging intervention? Balmford, J., Borland, R.[2018]

Text messaging interventions for smoking cessation show promise, with 22 studies indicating that these programs can effectively motivate individuals to quit smoking, particularly among adults aged 30-40 and young adults aged 18-29.

While some interventions demonstrated better smoking cessation outcomes than control conditions, more rigorous research is needed to identify the most effective components of these text messaging strategies to enhance their overall efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Text messaging-based smoking cessation intervention: a narrative review. Kong, G., Ells, DM., Camenga, DR., et al.[2022]

A study involving 102 young adult smokers found that a smartphone application (REQ-Mobile) was feasible for smoking cessation support, with 75% of users rating it as user-friendly.

However, the text messaging system (onQ) was more effective in promoting abstinence, with a significant number of users reporting higher rates of quitting compared to those using the app.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized trial of a smartphone mobile application compared to text messaging to support smoking cessation. Buller, DB., Borland, R., Bettinghaus, EP., et al.[2022]

Smartphone applications for smoking cessation have been shown to increase quit rates among smokers, particularly when users engage with features like audiovisual content, quit plans, and progress tracking.

While these apps can help reduce relapse rates, the effectiveness varies based on how well users adhere to the app's features, indicating that user engagement is crucial for success.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Mobile Apps for Smoking Cessation: A Review. Regmi, K., Kassim, N., Ahmad, N., et al.[2020]

The study aims to enhance adherence to a web-based smoking cessation program by integrating a text messaging intervention, focusing on four key features: personalisation, integration, dynamic tailoring, and message intensity, with 860 adult smokers participating in the initial phase.

In the second phase, 600 adult smokers will be randomly assigned to either the web-based program alone or the program combined with the optimized text messaging intervention, with the goal of measuring the impact on smoking cessation rates after 9 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimising text messaging to improve adherence to web-based smoking cessation treatment: a randomised control trial protocol. Graham, AL., Jacobs, MA., Cohn, AM., et al.[2019]

Citations

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