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

NCT05991934 | Completed Results

• 2 other identifiers: IRB00013413-PilotIRB00013413
• Study Type: interventional
• Target: 12
• 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)

• 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.

  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.

  Baseline, 45-day follow-up

Study Arms (1)

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).

Behavioral: Smartphone-based intervention messages

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.

Single arm pilot

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 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.

You may not qualify if:

• 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

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

Location

Related Publications (1)

• 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.

  PMID: 41211017 DERIVED

Results Point of Contact

• Title: Johannes Thrul, PhD
• Organization: Johns Hopkins Bloomberg School of Public Health

jthrul@jhu.edu

(443) 318-6633‬

Study Officials

• Johannes Thrul, PhD

  Johns Hopkins Bloomberg School of Public Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Model Details: 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.

Study Record Dates

• First Submitted: August 7, 2023
• First Posted: August 15, 2023
• Study Start: November 29, 2023
• Primary Completion: April 18, 2024
• Study Completion: April 30, 2024
• Last Updated: May 20, 2025
• Results First Posted: May 20, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share

Locations

US (1)