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

NCT05836103 | Recruiting

• 1 other identifier: IRB00013413
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Tobacco Cigarette Smoking

Outcome Measures

Primary Outcomes (2)

• 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).

  15 minutes after message delivery

• 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.

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

Secondary Outcomes (18)

• Smoking since intervention message delivery as assessed by a single item

  15 minutes after message deliery

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

  15 minutes after message delivery

• Change in stress as assessed by a single item

  15 minutes after message delivery

• Change in negative affect as assessed by a single item

  15 minutes after message delivery

• Message helpfulness as assessed by a single item

  15 minutes after message delivery

Study Arms (2)

Micro-randomized trial group

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).

Behavioral: Smartphone-based intervention messages

EMA-only control group

NO 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.

Interventions

Smartphone-based intervention messages 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.

Micro-randomized trial group

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• None

Sponsors & Collaborators

• Johns Hopkins Bloomberg School of Public Health: lead

Study Sites (1)

Johns Hopkins Bloomberg School of Public Health

Baltimore, Maryland, 21205, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 40987452 DERIVED

Study Officials

• Johannes Thrul, PhD

  Johns Hopkins Bloomberg School of Public Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Johannes Thrul, PhD

CONTACT

410-502-0925; jthrul@jhu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 18, 2023
• First Posted: May 1, 2023
• Study Start: October 22, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: June 19, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ANALYTIC CODE

Locations

US (1)