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

NCT ID: NCT05836103

Last Updated: 2025-06-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-22
• Study Completion Date: 2026-06-30

Brief 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 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.

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.

Conditions

Tobacco Cigarette Smoking

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Micro-randomized trial group

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 Type: EXPERIMENTAL

Smartphone-based intervention messages

Intervention Type: BEHAVIORAL

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.

EMA-only control group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Smartphone-based intervention messages

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. live in the U.S.

2. read English;

3. are between 18 and 30 years of age;

4. own an iPhone or Android smartphone;

5. have smoked ≥100 cigarettes in their lives and currently smoke at least 3 cigarettes per day on 5 or more days of the week;

6. are planning to quit smoking within the next 30 days.

Exclusion Criteria

• None

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johns Hopkins Bloomberg School of Public Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Johannes Thrul, PhD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins Bloomberg School of Public Health

Locations

Johns Hopkins Bloomberg School of Public Health

Baltimore, Maryland, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Johannes Thrul, PhD

Role: CONTACT

jthrul@jhu.edu

410-502-0925

Facility Contacts

Johannes Thrul, PhD

Role: primary

jthrul@jhu.edu

410-502-0925

References

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.

Reference Type: DERIVED

PMID: 40987452 (View on PubMed)

Other Identifiers

IRB00013413

Identifier Type: -

Identifier Source: org_study_id