Tobacco Cigarette SmokingNCT05991934

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

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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12 participants
Where: 1 siteUnited States
Study dates: 29 Nov 2023to 30 Apr 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 and currently smoke at least 1 cigarette per day on 3 or more days of the week;
are planning to quit smoking within the next 30 days.

Who cannot join

live internationally
don't read English
younger than 18, older than 30
don't own a iPhone or Android smartphone
have smoked less than 100 cigarettes
not planning to quit smoking in the next 30 days

Trial locations and contacts

1 site in 1 country.

United States1 site

Johns Hopkins Bloomberg School of Public Health
Baltimore, Maryland, 21205

Other trials in United States

About this study

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

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

To conduct a pilot trial to test CBT and Mindfulness/ACT intervention message efficacy for reducing momentary smoking urges (N=10). 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. After 45 days, follow up interviews with participants will be conducted to collect information on their study experience.

Conditions: Tobacco Cigarette Smoking
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 NCT05991934
Study group	Role	What they receive
Single arm pilot	Experimental	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). Receives: Behavioral: Smartphone-based intervention messages

What is being measured

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

Smoking Urge as Assessed by Survey Item
The primary outcome is change in participants' rating of smoking urge from pre- to post-message surveys. Urge is assessed by a single item on a 5-point scale, ranging from 1 (very low) to 5 (very high) in pre and post surveys. Pre-message surveys are completed immediately before message delivery and post-message surveys are prompted 15 minutes after intervention message delivery. . Data presented here are Mean and Standard Deviation of smoking urge before (pre-message EMA) and after (follow-up EMA) a message was delivered for the different message conditions (Control, Cognitive behavioral therapy (CBT), Mindfulness or Acceptance and commitment Therapy (ACT)). Messages were randomized within subjects.
Measured: Baseline, 15 minutes after message delivery
Change in Number of 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-days.
Measured: Baseline, 45-day follow-up

Timeline

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

29 Nov 202330 Apr 2024

First posted15 Aug 2023
Study start29 Nov 2023
Primary completion18 Apr 2024
Study completion30 Apr 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Tobacco Cigarette SmokingStudies of the same condition, open and under way.
More trials run by Johns Hopkins Bloomberg School of Public HealthThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Not applicable
Intervention model: Single group
Model description: A pilot micro-randomized trial (within-subject randomization) with 10 young adult smokers will investigate the feasibility of delivering smoking cessation messages based on CBT and mindfulness/ACT for reducing smoking urge 15 minutes after message delivery.
Masking: None (open label)
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05991934
Sponsor's protocol ID: IRB00013413-Pilot
Other IDs: IRB00013413
Status last verified: May 2025
First submitted: 7 Aug 2023
Last updated: 20 May 2025
Results posted: Yes, on ClinicalTrials.gov
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, Hamoud J, Waring JJC, Luken A, Han JJ, Naughton F, Zipunnikov V, Mendelson T, Latkin C, Moran M, Epstein D, Desjardins MR. Micro-randomized pilot trial of an app-based smoking urge reduction intervention for young adults. Mhealth. 2025 Oct 29;11:59. doi: 10.21037/mhealth-25-17. eCollection 2025.
PubMed 41211017

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 20 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Testing the Impact of Smartphone-based Messaging to Support Young Adult Smoking Cessation
ClinicalTrials.gov ID: NCT05991934
Acronym / sponsor ID: IRB00013413-Pilot
Conditions: Tobacco Cigarette Smoking
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
Study start: 29 Nov 2023 (actual)
Primary completion: 18 Apr 2024 (actual)
Study completion: 30 Apr 2024 (actual)
First posted: 15 Aug 2023 (actual)
Results: Posted 20 May 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: A pilot micro-randomized trial (within-subject randomization) with 10 young adult smokers will investigate the feasibility of delivering smoking cessation messages based on CBT and mindfulness/ACT for reducing smoking urge 15 minutes after message delivery.

Arm	Type	Receives
Single arm pilot	Experimental	Behavioral: Smartphone-based intervention messagesThe 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).

Who may qualify

Ages: 18 to 30 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (6 listed)

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 and currently smoke at least 1 cigarette per day on 3 or more days of the week;

Key exclusion criteria (6 listed)

live internationally
don't read English
younger than 18, older than 30
don't own a iPhone or Android smartphone
have smoked less than 100 cigarettes

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Smartphone-based intervention messagesIntervention 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.	Behavioural	Single arm pilot

Primary outcome

Smoking Urge as Assessed by Survey Item
Time frame: Baseline, 15 minutes after message delivery
The primary outcome is change in participants' rating of smoking urge from pre- to post-message surveys. Urge is assessed by a single item on a 5-point scale, ranging from 1 (very low) to 5 (very high) in pre and post surveys. Pre-message surveys are completed immediately before message delivery and post-message surveys are prompted 15 minutes after intervention message delivery. . Data presented here are Mean and Standard Deviation of smoking urge before (pre-message EMA) and after (follow-up EMA) a message was delivered for the different message conditions (Control, Cognitive behavioral therapy (CBT), Mindfulness or Acceptance and commitment Therapy (ACT)). Messages were randomized within subjects.
Change in Number of Cigarettes Smoked Per Day in Past Week as Assessed by a Single Item
Time frame: Baseline, 45-day follow-up
The primary outcome will be change in self-reported number of cigarettes smoked per day in the past week from baseline to 45-days.

Results and safety

Results posted to the registry on 20 May 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Single Arm Pilot	12	8

Primary outcome: Smoking Urge as Assessed by Survey Item

Time frame: Baseline, 15 minutes after message delivery. Mean (Standard Deviation). Unit: units on a scale

Measure	Single Arm Pilot n = 8
Control: Pre-message EMA, smoking urge	2.59 (1.30)
Control: Follow-up EMA, smoking urge	2.39 (1.27)
CBT: Pre-message EMA, smoking urge	2.53 (1.50)
CBT: Follow-up EMA, smoking urge	2.16 (1.35)
ACT: Pre-message EMA, smoking urge	2.76 (1.34)
ACT: Follow-up EMA, smoking urge	2.40 (1.30)

Population analysed: A total of 4 participants removed after the initial assessment phase who did not provide required data to construct geo-fences of high-risk situations for smoking that were required for the intervention phase and thus did not advance to the intervention phase and did not receive intervention messages.

Primary outcome: Change in Number of Cigarettes Smoked Per Day in Past Week as Assessed by a Single Item

Time frame: Baseline, 45-day follow-up. Mean (Standard Deviation). Unit: Cigarettes per day

Measure	Single Arm Pilot n = 8
Baseline	7.1 (5.8)
45-day follow-up	3.2 (2.2)

Adverse events

Time frame: Up to 45 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Single Arm Pilot	0 of 12 (0%)	0 of 12 (0%)	0 of 12

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 41211017Thrul J, Devkota J, Hamoud J, Waring JJC, Luken A, Han JJ, Naughton F, Zipunnikov V, Mendelson T, Latkin C, Moran M, Epstein D, Desjardins MR. Micro-randomized pilot trial of an app-based smoking urge reduction intervention for young adults. Mhealth. 2025 Oct 29;11:59. doi: 10.21037/mhealth-25-17. eCollection 2025.
Individual participant dataSharing planned: Yes. Any individual requests for data will be honored on a case-by-case basis as deemed appropriate to the research protocol.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Johannes Thrul, PhD principal investigator

Johns Hopkins Bloomberg School of Public Health

1 site in 1 country: see every site and its status.

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 6 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: finished, as of the sponsor's last update on 20 May 2025. 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?

Yes. Results are posted in the registry (first posted 20 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Smoking Urge as Assessed by Survey Item (time frame: Baseline, 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 NCT05991934, 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 20 May 2025.