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| Name | Class |
|---|---|
| Maryland Cigarette Restitution | UNKNOWN |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RL-informed intervention | Experimental | Participants complete a 14-day Ecological Momentary Assessment (EMA) training phase using a smartphone app (MetricWire), during which the participant responds to up to 3 randomly prompted and cigarette-triggered EMA surveys per day while the app passively collects GPS data. These data are used to identify high-risk locations and time periods and to inform a previously trained reinforcement learning (RL) algorithm. During the subsequent 30-day intervention phase, the RL algorithm delivers personalized intervention messages (cognitive-behavioral therapy [CBT], acceptance and commitment therapy [ACT], or attention control) triggered by geofence entry at high-risk locations. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Smartphone-based intervention messages | Behavioral | Intervention messages will suggest strategies of coping with smoking urges in the moment. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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. | 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. | 45-day follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 15 minutes after message delivery |
| Other tobacco product use since intervention message delivery as assessed by a single item |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Johannes Thrul, PhD | Contact | 443-318-6633 | jthrul@jhu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Johannes Thrul, PhD | Johns Hopkins Bloomberg School of Public Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Bloomberg School of Public Health | Baltimore | Maryland | 21205 | United States |
Johns Hopkins Bloomberg School of Public Health
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| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
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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). |
| 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). | 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). | 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). | 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). | 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). | 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. | 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). | 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. | 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. | 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. | 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. | Baseline, 45-day follow-up |