Testing the Impact of Smartphone-based Messaging to Support Young Adult Smoking Cessation

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Testing the Impact of Smartphone-based Messaging to Support Young Adult Smoking Cessation

Conditions
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Tobacco Cigarette Smoking

Intervention / Treatment
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* Behavioral: Smartphone-based intervention messages


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: live in the U.S. read English; are between 18 and 30 years of age; own an iPhone or Android smartphone; have smoked ≥100 cigarettes and currently smoke at least 1 cigarette per day on 3 or more days of the week; are planning to quit smoking within the next 30 days. Exclusion Criteria: live internationally don't read English younger than 18, older than 30 don't own a iPhone or Android smartphone have smoked less than 100 cigarettes not planning to quit smoking in the next 30 days

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single arm pilot<br>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). | Behavioral: Smartphone-based intervention messages<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 (very low) to 5 (very high). | Baseline, 5 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 |