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| ID | Type | Description | Link |
|---|---|---|---|
| IRB00013413 | Other Identifier | JHSPH IRB |
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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.
To conduct a pilot trial to test CBT and Mindfulness/ACT intervention message efficacy for reducing momentary smoking urges (N=10). 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. After 45 days, follow up interviews with participants will be conducted to collect information on their study experience.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single arm pilot | Experimental | The micro-randomized trial will determine if CBT and Mindfulness/ACT messages are superior to control messages in reducing the primary outcome momentary smoking urges. Based on participants' training data collected in the initial 14 days of EMA monitoring, intervention messages will be delivered during time-periods and at high-risk locations for smoking. In the intervention phase, participants will be prompted to complete 3 geofence-triggered EMAs per day for a total of 30 days. Each EMA will be followed by an intervention message and the type of message (CBT, Mindfulness/ACT, control) will be randomly selected at each time point (within-subject randomization). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Smoking Urge as Assessed by Survey Item | The primary outcome is change in participants' rating of smoking urge from pre- to post-message surveys. Urge is assessed by a single item on a 5-point scale, ranging from 1 (very low) to 5 (very high) in pre and post surveys. Pre-message surveys are completed immediately before message delivery and post-message surveys are prompted 15 minutes after intervention message delivery. . Data presented here are Mean and Standard Deviation of smoking urge before (pre-message EMA) and after (follow-up EMA) a message was delivered for the different message conditions (Control, Cognitive behavioral therapy (CBT), Mindfulness or Acceptance and commitment Therapy (ACT)). Messages were randomized within subjects. | Baseline, 15 minutes after message delivery |
| Change in Number of 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-days. | Baseline, 45-day follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| 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 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41211017 | Derived | Thrul J, Devkota J, Hamoud J, Waring JJC, Luken A, Han JJ, Naughton F, Zipunnikov V, Mendelson T, Latkin C, Moran M, Epstein D, Desjardins MR. Micro-randomized pilot trial of an app-based smoking urge reduction intervention for young adults. Mhealth. 2025 Oct 29;11:59. doi: 10.21037/mhealth-25-17. eCollection 2025. |
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Any individual requests for data will be honored on a case-by-case basis as deemed appropriate to the research protocol.
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Participants were recruited through Facebook, Instagram, Reddit, and X advertisements that linked to a Qualtrics screening survey. All participants who met eligibility criteria had to provide online consent prior to study involvement. After consenting to participate but before being enrolled into the study, participants were required to send study staff a picture of a valid identification (e.g., driver's license) that had their name, picture, and birthdate to validate their age and identity.
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| ID | Title | Description |
|---|---|---|
| FG000 | Single Arm Pilot | The micro-randomized trial will determine if CBT and Mindfulness/ACT messages are superior to control messages in reducing the primary outcome momentary smoking urges. Based on participants' training data collected in the initial 14 days of EMA monitoring, intervention messages will be delivered during time-periods and at high-risk locations for smoking. In the intervention phase, participants will be prompted to complete 3 geofence-triggered EMAs per day for a total of 30 days. Each EMA will be followed by an intervention message and the type of message (CBT, Mindfulness/ACT, control) will be randomly selected at each time point (within-subject randomization). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Single Arm Pilot | The micro-randomized trial will determine if CBT and Mindfulness/ACT messages are superior to control messages in reducing the primary outcome momentary smoking urges. Based on participants' training data collected in the initial 14 days of EMA monitoring, intervention messages will be delivered during time-periods and at high-risk locations for smoking. In the intervention phase, participants will be prompted to complete 3 geofence-triggered EMAs per day for a total of 30 days. Each EMA will be followed by an intervention message and the type of message (CBT, Mindfulness/ACT, control) will be randomly selected at each time point (within-subject randomization). |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Smoking Urge as Assessed by Survey Item | The primary outcome is change in participants' rating of smoking urge from pre- to post-message surveys. Urge is assessed by a single item on a 5-point scale, ranging from 1 (very low) to 5 (very high) in pre and post surveys. Pre-message surveys are completed immediately before message delivery and post-message surveys are prompted 15 minutes after intervention message delivery. . Data presented here are Mean and Standard Deviation of smoking urge before (pre-message EMA) and after (follow-up EMA) a message was delivered for the different message conditions (Control, Cognitive behavioral therapy (CBT), Mindfulness or Acceptance and commitment Therapy (ACT)). Messages were randomized within subjects. | A total of 4 participants removed after the initial assessment phase who did not provide required data to construct geo-fences of high-risk situations for smoking that were required for the intervention phase and thus did not advance to the intervention phase and did not receive intervention messages. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 15 minutes after message delivery | Message exposures | Message exposures |
Up to 45 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Single Arm Pilot | The micro-randomized trial will determine if CBT and Mindfulness/ACT messages are superior to control messages in reducing the primary outcome momentary smoking urges. Based on participants' training data collected in the initial 14 days of EMA monitoring, intervention messages will be delivered during time-periods and at high-risk locations for smoking. In the intervention phase, participants will be prompted to complete 3 geofence-triggered EMAs per day for a total of 30 days. Each EMA will be followed by an intervention message and the type of message (CBT, Mindfulness/ACT, control) will be randomly selected at each time point (within-subject randomization). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Johannes Thrul, PhD | Johns Hopkins Bloomberg School of Public Health | (443) 318-6633 | jthrul@jhu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 19, 2025 | May 2, 2025 | Prot_SAP_000.pdf |
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A pilot micro-randomized trial (within-subject randomization) with 10 young adult smokers will investigate the feasibility of delivering smoking cessation messages based on CBT and mindfulness/ACT for reducing smoking urge 15 minutes after message delivery.
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| Sex: Female, Male | Count of Participants | Participants | No |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
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| Race (NIH/OMB) | Count of Participants | Participants | No |
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| ID |
|---|
| Title |
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| Description |
|---|
| OG000 | Single Arm Pilot | The micro-randomized trial will determine if CBT and Mindfulness/ACT messages are superior to control messages in reducing the primary outcome momentary smoking urges. Based on participants' training data collected in the initial 14 days of EMA monitoring, intervention messages will be delivered during time-periods and at high-risk locations for smoking. In the intervention phase, participants will be prompted to complete 3 geofence-triggered EMAs per day for a total of 30 days. Each EMA will be followed by an intervention message and the type of message (CBT, Mindfulness/ACT, control) will be randomly selected at each time point (within-subject randomization). |
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| Primary | Change in Number of 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-days. | A total of 4 participants removed after the initial assessment phase who did not provide required data to construct geo-fences of high-risk situations for smoking that were required for the intervention phase and thus did not advance to the intervention phase and did not receive intervention messages. | Posted | Mean | Standard Deviation | Cigarettes per day | Baseline, 45-day follow-up |
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| 0 |
| 12 |
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| 12 |
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| 12 |
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