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NCT Number: NCT05836103

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.

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Key information

Conditions

Tobacco Cigarette Smoking

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins Bloomberg School of Public Health

Baltimore, Maryland, 21205, United States

Location status: Recruiting

Location contact

Johannes Thrul, PhD

CONTACT

[email protected]

410-502-0925

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • None

Treatment and study plan

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.

Primary outcomes

  1. Change in smoking urge as assessed by a single item

    Time frame: 15 minutes after message delivery

    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).

  2. 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

    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.

Secondary outcomes

  1. Smoking since intervention message delivery as assessed by a single item

    Time frame: 15 minutes after message deliery

    Smoking in the 15 minutes after message delivery will be assessed by a single item on a binary response scale (yes/no).

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

    Time frame: 15 minutes after message delivery

    Other tobacco product use, including e-cigarette use, in the 15 minutes after message delivery will be assessed by a single item on a binary response scale (yes/no).

  3. Change in stress as assessed by a single item

    Time frame: 15 minutes after message delivery

    Change in rating of stress in EMA-post surveys, prompted 15 minutes after intervention message delivery, and controlling for the ratings in EMA-pre surveys. Stress will be assessed by a single item on a 5-point scale, ranging from 1 (very low) to 5 (very high).

  4. Change in negative affect as assessed by a single item

    Time frame: 15 minutes after message delivery

    Change in rating of negative affect in EMA-post surveys, prompted 15 minutes after intervention message delivery, and controlling for the ratings in EMA-pre surveys. Negative affect will be assessed by a single item on a 5-point scale, ranging from 1 (very low) to 5 (very high).

  5. Message helpfulness as assessed by a single item

    Time frame: 15 minutes after message delivery

    Rating of message helpfulness in EMA-post surveys, prompted 15 minutes after intervention message delivery. This will be assessed by a single item on a 5-point scale, ranging from 1 (not at all helpful) to 5 (extremely helpful).

  6. Activity completion as assessed by a single item

    Time frame: 15 minutes after message delivery

    Self-reported completion of intervention message recommendation in EMA-post surveys, prompted 15 minutes after intervention message delivery will be assessed by a single item on a binary response scale (yes/no).

  7. Self-reported 7-day point prevalence abstinence as assessed by a single item

    Time frame: 45-day follow-up

    Self-reported 7-day point prevalence abstinence (no smoking, not even a puff) will be assessed by a single item on a binary response scale (yes/no).

  8. Self-reported 7-day point prevalence abstinence as assessed by a single item

    Time frame: 3-month follow-up

    Self-reported 7-day point prevalence abstinence (no smoking, not even a puff) will be assessed by a single item on a binary response scale (yes/no).

  9. Self-reported 7-day point prevalence abstinence as assessed by a single item

    Time frame: 6-month follow-up

    Self-reported 7-day point prevalence abstinence (no smoking, not even a puff) will be assessed by a single item on a binary response scale (yes/no).

  10. Saliva-cotinine confirmed 7-day point prevalence abstinence

    Time frame: 45-day follow-up

    Saliva-cotinine confirmed 7-day point prevalence abstinence. This will be assessed using saliva test strips and photo confirmation.

  11. Saliva-cotinine confirmed 7-day point prevalence abstinence

    Time frame: 3-month follow-up

    Saliva-cotinine confirmed 7-day point prevalence abstinence. This will be assessed using saliva test strips and photo confirmation.

  12. Saliva-cotinine confirmed 7-day point prevalence abstinence

    Time frame: 6-month follow-up

    Saliva-cotinine confirmed 7-day point prevalence abstinence. This will be assessed using saliva test strips and photo confirmation.

  13. Change in cigarettes smoked as assessed by a single item

    Time frame: Baseline, 45-day, 3-month, and 6-month follow-up

    Change (reduction) in cigarettes smoked by at least 50% between baseline and each follow-up timepoint. Reduction will be calculated based on self-reported number of cigarettes/day in the past week.

  14. Tobacco quit attempt as a assessed by a single item

    Time frame: Baseline, 45-day, 3-month, and 6-month follow-up

    A tobacco quit attempt since last assessment will be assessed by a single item on a binary response scale (yes/no).

  15. Change in frequency and intensity of smoking urges as assessed by two items of the Mood and Physical Symptoms Scale (MPSS)

    Time frame: Baseline, 45-day, 3-month, and 6-month follow-up

    Change in frequency and intensity of smoking urges will be assessed by two craving items from the Assessed with the Mood and Physical Symptoms Scale (MPSS) - subscale MPSS(C). Both items will be assessed on a 6-point scale from 0 (not at all / no urges) to 5 (all the time / extremely strong). Both items will be combined into the MPSS(C) subscale for analysis.

  16. Change in psychological flexibility as assessed by the CompACT-15

    Time frame: Baseline, 45-day, 3-month, and 6-month follow-up

    Change in psychological flexibility from baseline to 45-day, 3-month, and 6-month follow-up will be assessed by the CompACT-15. The CompACT-15 total score ranges from 0-90, with higher scores indicating greater psychological flexibility.

  17. Change in smoking-specific experiential avoidance as assessed by the Avoidance and Inflexibility Scale (AIS)

    Time frame: Baseline, 45-day, 3-month, and 6-month follow-up

    Change in smoking-specific experiential avoidance from baseline to 45-day, 3-month, and 6-month follow-up will be assessed by the Avoidance and Inflexibility Scale (AIS). Items are scored on a scale of 1-5 and combined into a total score. A higher total score indicates a more avoidant and inflexible response to internal states associated with smoking.

  18. Tobacco product switching as assessed by 5 questions

    Time frame: Baseline, 45-day, 3-month, and 6-month follow-up

    Switching to other tobacco products including e-cigarettes from baseline to 45-day, 3-month, and 6-month follow-up will be assessed using questions about past 7-day use of cigarettes, e-cigarettes, cigars / cigarillos / little cigars, smokeless tobacco, and hookah / waterpipe. Participants will be coded as having switched if they do not report cigarette smoking, but use of another tobacco product at a follow-up assessment.

Study contacts

Contact information is provided by the study sponsor or research team.

Johannes Thrul, PhD

CONTACT

[email protected]

410-502-0925

Sponsors and collaborators

Lead sponsor

Johns Hopkins Bloomberg School of Public Health

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
May 1, 2023
Registry last updated
Jun 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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