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Tobacco Cigarette SmokingNCT05836103

Testing the Impact of Smartphone-based Messaging to Support Young Adult Smoking Cessation

A study testing Smartphone-based intervention messages in people with Tobacco Cigarette Smoking, run by Johns Hopkins Bloomberg School of Public Health at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Clinical practice guidelines for smoking cessation emphasize cognitive behavioral therapy (CBT) to help patients develop coping strategies for urges. Mindfulness or Acceptance and Commitment Therapy (ACT) offer a different approach, which teaches smokers psychological flexibility through accepting negative… Read more about this study

Who is it for?
Ages 18 to 30 years
Conditions the study is for
Tobacco Cigarette Smoking
What is being tested?
Smartphone-based intervention messages
Could I receive a placebo?
No, everyone receives an active treatment
How many people
160 participants
Where
1 siteUnited States
Study dates
22 Oct 2024to 30 Nov 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 30 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • live in the U.S.
  • read English;
  • are between 18 and 30 years of age;
  • own an iPhone or Android smartphone;
  • have smoked ≥100 cigarettes in their lives and currently smoke at least 3 cigarettes per day on 5 or more days of the week;
  • are planning to quit smoking within the next 30 days.

Who cannot join

  • None

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Johannes Thrul, PhD contact

410-502-0925

jthrul@jhu.edu

United States1 site, 1 recruiting
  • Johns Hopkins Bloomberg School of Public Health

    Baltimore, Maryland, 21205

    Johannes Thrul, PhD, 410-502-0925, jthrul@jhu.edu

    Recruiting

Other trials in United States

About this study

Clinical practice guidelines for smoking cessation emphasize cognitive behavioral therapy (CBT) to help patients develop coping strategies for urges. Mindfulness or Acceptance and Commitment Therapy (ACT) offer a different approach, which teaches smokers psychological flexibility through accepting negative experiences. While there is evidence for the efficacy of both CBT and Mindfulness/ACT smoking cessation interventions, it is unclear if these approaches are efficacious when implemented in real-time and with young adults. The overall goal of this proposal is to evaluate the efficacy of CBT and Mindfulness/ACT messages for young adults targeted at specific high-risk situations for smoking.

Read the detailed description

This research will address the following specific aims:

Aim 1: To test CBT and Mindfulness/ACT intervention message efficacy for reducing momentary smoking urges (N=80). To inform just-in-time interventions, it is crucial to test if CBT and Mindfulness/ACT based messages can reduce momentary smoking urges. The investigators will conduct a micro-randomized trial (repeated within-subject randomizations of messages) to accomplish this. In line with the investigators' existing protocol, participants first collect Ecological Momentary Assessment (EMA) data for 14 days, allowing the investigators to determine high-risk situations for smoking. In the following intervention phase, participants receive tailored messages triggered by geofencing of participants' high-risk locations for a total of 30 days. Tailoring is based on established predictors of smoking relapse (stress and presence of other smokers). The micro-randomized trial tests the efficacy of CBT versus Mindfulness/ACT versus control messages for reducing smoking urge 15 minutes post message delivery. Secondary outcomes include smoking or other tobacco use (including e-cigarettes), affect, and stress.

Aim 2: To test if exposure to urge reduction messages results in changes in smoking behavior over time compared to an EMA only control group (N=80). It is important to investigate if repeated messages in the micro-randomized trial impact smoking behavior over time, in contrast to just repeated assessment without messages. Thus, this study includes a conventionally randomized clinical-trial component. Parallel to the micro-randomized trial group, a control group completes EMA surveys only without intervention messages. This allows the investigators to test if messages reduce smoking behavior. The primary outcome is number of cigarettes per day at end of treatment, 3-, and 6-months follow-up. Secondary analyses explore biochemically verified 7-day point prevalence abstinence, switching to e-cigarettes, and other tobacco outcomes. Post-hoc dose-response analyses investigate the long-term efficacy of CBT or Mindfulness/ACT messages on smoking behavior.

Aim 3: Explore moderation effects of substance co-use (cannabis, alcohol, other drugs) and exposure to specific location (home, work, bars) on urge reduction message efficacy. A crucial research question to inform future mobile interventions is how well intervention messages work in different situational contexts and when people are co-using other substances. Among intervention group participants, the investigators will explore how urge reduction message efficacy may be moderated by substance co-use and exposure to specific settings.

Being tested
Smartphone-based intervention messages

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Smartphone-based intervention messagesBehavioural

    Intervention messages in the proposed trial will address specific high-risk situations for smoking and smoking urges. Messages will focus on two key situational triggers for message matching: 1. Stress (high/low) and 2. Presence of other smokers (yes/no). For each situation, characterized by a combination of these characteristics, several messages were developed. To improve user engagement with the intervention, all messages contain visual content in form of pictures.

Study groups in NCT05836103
Study groupRoleWhat they receive
Micro-randomized trial groupExperimentalThe 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).
Receives: Behavioral: Smartphone-based intervention messages
EMA-only control groupNo interventionA 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in smoking urge as assessed by a single item

    The primary outcome will be change in participants' rating of smoking urge in EMA-post surveys, prompted 15 minutes after intervention message delivery, and controlling for the ratings in EMA-pre surveys. Urge will be assessed by a single item on a 5-point scale, ranging from 1 (very low) to 5 (very high).

    Measured: 15 minutes after message delivery

  2. Change in cigarettes smoked per day in past week as assessed by a single item

    The primary outcome will be change in self-reported number of cigarettes smoked per day in the past week from baseline to 45-day, 3-month, and 6-month follow-up.

    Measured: Baseline, 45-day, 3-month, and 6-month follow-up

Secondary outcomes (18)
  1. Smoking since intervention message delivery as assessed by a single item

    Smoking in the 15 minutes after message delivery will be assessed by a single item on a binary response scale (yes/no).

    Measured: 15 minutes after message deliery

  2. Other tobacco product use since intervention message delivery as assessed by a single item

    Other tobacco product use, including e-cigarette use, in the 15 minutes after message delivery will be assessed by a single item on a binary response scale (yes/no).

    Measured: 15 minutes after message delivery

  3. Change in stress as assessed by a single item

    Change in rating of stress in EMA-post surveys, prompted 15 minutes after intervention message delivery, and controlling for the ratings in EMA-pre surveys. Stress will be assessed by a single item on a 5-point scale, ranging from 1 (very low) to 5 (very high).

    Measured: 15 minutes after message delivery

  4. Change in negative affect as assessed by a single item

    Change in rating of negative affect in EMA-post surveys, prompted 15 minutes after intervention message delivery, and controlling for the ratings in EMA-pre surveys. Negative affect will be assessed by a single item on a 5-point scale, ranging from 1 (very low) to 5 (very high).

    Measured: 15 minutes after message delivery

  5. Message helpfulness as assessed by a single item

    Rating of message helpfulness in EMA-post surveys, prompted 15 minutes after intervention message delivery. This will be assessed by a single item on a 5-point scale, ranging from 1 (not at all helpful) to 5 (extremely helpful).

    Measured: 15 minutes after message delivery

  6. Activity completion as assessed by a single item

    Self-reported completion of intervention message recommendation in EMA-post surveys, prompted 15 minutes after intervention message delivery will be assessed by a single item on a binary response scale (yes/no).

    Measured: 15 minutes after message delivery

  7. Self-reported 7-day point prevalence abstinence as assessed by a single item

    Self-reported 7-day point prevalence abstinence (no smoking, not even a puff) will be assessed by a single item on a binary response scale (yes/no).

    Measured: 45-day follow-up

  8. Self-reported 7-day point prevalence abstinence as assessed by a single item

    Self-reported 7-day point prevalence abstinence (no smoking, not even a puff) will be assessed by a single item on a binary response scale (yes/no).

    Measured: 3-month follow-up

  9. Self-reported 7-day point prevalence abstinence as assessed by a single item

    Self-reported 7-day point prevalence abstinence (no smoking, not even a puff) will be assessed by a single item on a binary response scale (yes/no).

    Measured: 6-month follow-up

  10. Saliva-cotinine confirmed 7-day point prevalence abstinence

    Saliva-cotinine confirmed 7-day point prevalence abstinence. This will be assessed using saliva test strips and photo confirmation.

    Measured: 45-day follow-up

  11. Saliva-cotinine confirmed 7-day point prevalence abstinence

    Saliva-cotinine confirmed 7-day point prevalence abstinence. This will be assessed using saliva test strips and photo confirmation.

    Measured: 3-month follow-up

  12. Saliva-cotinine confirmed 7-day point prevalence abstinence

    Saliva-cotinine confirmed 7-day point prevalence abstinence. This will be assessed using saliva test strips and photo confirmation.

    Measured: 6-month follow-up

  13. Change in cigarettes smoked as assessed by a single item

    Change (reduction) in cigarettes smoked by at least 50% between baseline and each follow-up timepoint. Reduction will be calculated based on self-reported number of cigarettes/day in the past week.

    Measured: Baseline, 45-day, 3-month, and 6-month follow-up

  14. Tobacco quit attempt as a assessed by a single item

    A tobacco quit attempt since last assessment will be assessed by a single item on a binary response scale (yes/no).

    Measured: Baseline, 45-day, 3-month, and 6-month follow-up

  15. Change in frequency and intensity of smoking urges as assessed by two items of the Mood and Physical Symptoms Scale (MPSS)

    Change in frequency and intensity of smoking urges will be assessed by two craving items from the Assessed with the Mood and Physical Symptoms Scale (MPSS) - subscale MPSS(C). Both items will be assessed on a 6-point scale from 0 (not at all / no urges) to 5 (all the time / extremely strong). Both items will be combined into the MPSS(C) subscale for analysis.

    Measured: Baseline, 45-day, 3-month, and 6-month follow-up

  16. Change in psychological flexibility as assessed by the CompACT-15

    Change in psychological flexibility from baseline to 45-day, 3-month, and 6-month follow-up will be assessed by the CompACT-15. The CompACT-15 total score ranges from 0-90, with higher scores indicating greater psychological flexibility.

    Measured: Baseline, 45-day, 3-month, and 6-month follow-up

  17. Change in smoking-specific experiential avoidance as assessed by the Avoidance and Inflexibility Scale (AIS)

    Change in smoking-specific experiential avoidance from baseline to 45-day, 3-month, and 6-month follow-up will be assessed by the Avoidance and Inflexibility Scale (AIS). Items are scored on a scale of 1-5 and combined into a total score. A higher total score indicates a more avoidant and inflexible response to internal states associated with smoking.

    Measured: Baseline, 45-day, 3-month, and 6-month follow-up

  18. Tobacco product switching as assessed by 5 questions

    Switching to other tobacco products including e-cigarettes from baseline to 45-day, 3-month, and 6-month follow-up will be assessed using questions about past 7-day use of cigarettes, e-cigarettes, cigars / cigarillos / little cigars, smokeless tobacco, and hookah / waterpipe. Participants will be coded as having switched if they do not report cigarette smoking, but use of another tobacco product at a follow-up assessment.

    Measured: Baseline, 45-day, 3-month, and 6-month follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 May 2023
  2. Study start22 Oct 2024
  3. Primary completion30 Nov 2026 (estimated)
  4. Study completion30 Nov 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
The investigators propose to test tailored smartphone-based messages to support young adults in quitting smoking. This study addresses 3 specific aims. For Aim 1, a micro-randomized trial (within-subject randomization) with 80 young adult smokers will investigate the efficacy of smoking cessation messages based on CBT and mindfulness/ACT for reducing smoking urge 15 minutes after message delivery. In Aim 2, a built-in and conventionally randomized EMA-only control group will allow us to test if intervention messages result in changes in smoking behavior over time. The primary outcome will be self-reported number of cigarettes per day at end of treatment, as well as 3- and 6-month follow-up. Aim 3 will explore moderation effects of substance co-use (cannabis, alcohol, other drugs) and exposure to specific locations (home, work, bars) on urge reduction message efficacy among intervention group participants.
Masking
None (open label)
Enrolment
160 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05836103
Sponsor's protocol ID
IRB00013413
Status last verified
Jun 2026
First submitted
18 Apr 2023
Last updated
26 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Any individual requests for data will be honored on a case-by-case basis as deemed appropriate to the research protocol.

Publications

  • Thrul J, Devkota J, Waring JJC, Desjardins MR, Hamoud J, Han J, Naughton F, Zipunnikov V, Mendelson T, Latkin C, Epstein D, Moran M. App-Based Smoking Urge Reduction Intervention for Young Adults: Protocol Combining a Microrandomized Trial and Conventional Between-Subject Randomized Trial. JMIR Res Protoc. 2025 Sep 23;14:e74388. doi: 10.2196/74388.

    PubMed 40987452

Questions about this trial

What is this clinical trial studying?

A study testing Smartphone-based intervention messages in people with Tobacco Cigarette Smoking, run by Johns Hopkins Bloomberg School of Public Health at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Johannes Thrul, PhD (410-502-0925, jthrul@jhu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in smoking urge as assessed by a single item (time frame: 15 minutes after message delivery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05836103, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2026.

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