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NCT Number: NCT07585357

Adaptive Mobile Interventions to Reduce Cancer Risk Behaviors

Tobacco use remains the leading cause of preventable death, causing over 400,000 annual deaths in the United States alone. Smartphone-based interventions, particularly those leveraging real-time adaptive messaging, represent a promising yet underutilized approach to delivering personalized tobacco and cannabis treatment. The investigator's ongoing NCI funded micro-randomized trial (MRT; R01 CA246590) has shown initial feasibility in reducing smoking urges through situationally tailored cognitive-behavioral therapy (CBT) and mindfulness-based acceptance and commitment-based therapy (ACT) messages triggered by real-time contextual data (e.g., geolocation, momentary stress). To advance from a static MRT framework to a dynamic, data-driven just-in-time adaptive intervention (JITAI), this project aims to develop, test, and refine a reinforcement learning (RL) algorithm that can continuously adapt to user needs in real-time, enhancing treatment outcomes for various tobacco and cannabis products.

To ensure optimal usability and engagement, the investigators will conduct user-centered testing with the developed RL-based intervention delivery in one cohort (N=7) over 45 days. This will include usability assessment via the System Usability Scale, analysis of app interaction metrics, and semi-structured interviews to gather feedback for refining message content, timing, and design.

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Key information

Age range

18 year–40 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]

443-318-6633

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • live in the U.S.;
  • are between 18 and 40 years of age;
  • own a smartphone with iOS and Android operating system and GPS capabilities;
  • are carrying smartphone every day;
  • are willing to participate in the study for 44 days and give the research team access to the phone GPS data;
  • have smoked ≥100 cigarettes in the participant's life 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 will suggest strategies of coping with smoking urges in the moment.

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 1-5; (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 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 follow-up.

  3. System Usability as assessed by the System Usability Scale (SUS)

    Time frame: 45-day follow-up

    The primary outcome will be assessment of the intervention app usability assessed by a slightly modified version of the 10-item System Usability Scale ("system" wording changed to "app"). Each item is assessed on a 5-point scale from 1 (strongly disagree) to 5 (strongly agree). The SUS total score ranges from 0-100, with higher scores indicating greater usability.

Secondary outcomes

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

    Time frame: 15 minutes after message delivery

    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 1-5 (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 1-5 (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 1-5 (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. Change in cigarettes smoked as assessed by a single item

    Time frame: Baseline, 45-day follow-up

    Change (reduction) in cigarettes smoked by at least 50% between baseline and 45-day follow-up. Reduction will be calculated based on self-reported number of cigarettes/day in the past week.

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

    Time frame: 45-day follow-up

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

  10. 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 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). Score range 0-10. Lower score better. Both items will be combined into the MPSS(C) subscale for analysis.

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

    Time frame: Baseline, 45-day follow-up

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

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

    Time frame: Baseline, 45-day follow-up

    Change in smoking-specific experiential avoidance from baseline to 45-day 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. Score range 13-65, higher total score indicates a more avoidant and inflexible response to internal states associated with smoking.

  13. Tobacco product switching as assessed by 5 questions

    Time frame: Baseline, 45-day follow-up

    Switching to other tobacco products including e-cigarettes from baseline to 45-day 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 the participant does 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]

443-318-6633

Sponsors and collaborators

Lead sponsor

Johns Hopkins Bloomberg School of Public Health

Other

Collaborators

  • Maryland Cigarette Restitution

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 13, 2026
Registry last updated
Jul 27, 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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