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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
7
Intervention messages will suggest strategies of coping with smoking urges in the moment.
Johns Hopkins Bloomberg School of Public Health
Baltimore, Maryland, United States
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).
Time frame: 15 minutes after message delivery
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.
Time frame: Baseline, 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.
Time frame: 45-day follow-up
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).
Time frame: 15 minutes after message delivery
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).
Time frame: 15 minutes after message delivery
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).
Time frame: 15 minutes after message delivery
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).
Time frame: 15 minutes after message delivery
Message helpfulness as assessed by a single item
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).
Time frame: 15 minutes after message delivery
Activity completion as assessed by a single item
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).
Time frame: 15 minutes after message delivery
Self-reported 7-day point prevalence abstinence as assessed by a single item
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).
Time frame: 45-day follow-up
Change in cigarettes smoked as assessed by a single item
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.
Time frame: Baseline, 45-day follow-up
Tobacco quit attempt as a assessed by a single item
A tobacco quit attempt since the baseline assessment will be assessed by a single item on a binary response scale (yes/no).
Time frame: 45-day follow-up
Change in frequency and intensity of smoking urges as assessed by two items of the Mood and Physical Symptoms Scale (MPSS)
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.
Time frame: Baseline, 45-day follow-up
Change in psychological flexibility as assessed by the CompACT-15
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.
Time frame: Baseline, 45-day follow-up
Change in smoking-specific experiential avoidance as assessed by the Avoidance and Inflexibility Scale (AIS)
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.
Time frame: Baseline, 45-day follow-up
Tobacco product switching as assessed by 5 questions
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.
Time frame: Baseline, 45-day follow-up
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