About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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;
Disqualifiers
None
Trial design
Single group
Treatments tested in this trial
Smartphone-based intervention messages
BehavioralIntervention messages will suggest strategies of coping with smoking urges in the moment.
Treatment groups
Trial outcomes
Primary outcomes
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 1-5; (1-very low, to 5-very high).
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 follow-up.
System Usability as assessed by the System Usability Scale (SUS)
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
Smoking since intervention message delivery as assessed by a single item
Smoking in the 15 minutes after message delivery will be assessed by a single item on a binary response scale (yes/no).
Other tobacco product use since intervention message delivery as assessed by a single item
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).
Change in stress as assessed by a single item
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).
Change in negative affect as assessed by a single item
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).
Sponsors and contacts
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Johns Hopkins Bloomberg School of Public Health
Lead sponsor
Maryland Cigarette Restitution
Collaborator
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