Recruiting

Smoking Cessation

Sponsor:

Johns Hopkins Bloomberg School of Public Health

Code:

NCT05836103

Conditions

Tobacco Cigarette Smoking

Eligibility Criteria

Sex: All

Age: 18 - 30

Healthy Volunteers: Not accepted

Interventions

Smartphone-based intervention messages

Study Details

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

Study ID

NCT05836103

Start date

Oct 22, 2024

Status verified date

Jun, 2026

Completion date

Nov 30, 2026

Anticipated

Primary completion date

Nov 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 30

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

160 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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).

no intervention: 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.

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.

Primary outcome measure

  • Change in smoking urge as assessed by a single item [ Time Frame: 15 minutes after message delivery ]
  • Change in cigarettes smoked per day in past week as assessed by a single item [ Time Frame: Baseline, 45-day, 3-month, and 6-month follow-up ]

Central Contacts and Locations

Central contacts

Johannes Thrul, PhD

410-502-0925jthrul@jhu.edu

Locations

Johns Hopkins Bloomberg School of Public Health

Recruiting

Baltimore, Maryland, United States, 21205

Contacts

Johannes Thrul, PhD

410-502-0925jthrul@jhu.edu

More Information

Sponsor

Johns Hopkins Bloomberg School of Public Health

Last update posted

Jun 26, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Johns Hopkins Bloomberg School of Public Health on 2026-06-26.