Trial Summary
What is the purpose of this trial?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.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications.
What data supports the effectiveness of the treatment Smartphone-based intervention messages for smoking cessation?
Research shows that smartphone apps and text messaging can effectively support people in quitting smoking by providing real-time, personalized messages that help prevent smoking lapses. These interventions have been successful in various settings, including hospitals, and are increasingly used worldwide.
12345Is smartphone messaging support for smoking cessation safe for humans?
The research does not specifically mention any safety concerns related to smartphone messaging interventions for smoking cessation, suggesting they are generally considered safe for human use.
12467How is the smartphone messaging treatment for smoking cessation different from other treatments?
The smartphone messaging treatment for smoking cessation is unique because it uses text messages to provide support and motivation to quit smoking, making it accessible and convenient for users. Unlike traditional methods, it offers real-time interaction and personalized advice through mobile phones, which are widely available and easy to use.
23689Eligibility Criteria
This trial is for young adults in the U.S., aged 18-30, who can read English and want to quit smoking. They must have smoked over 100 cigarettes in their lifetime and currently smoke at least once on three days each week. Participants need to own a smartphone and plan to quit within the next month.Inclusion Criteria
Patients must live in the U.S.
Patients must be able to read English
Patients must own an iPhone or Android smartphone
+3 more
Exclusion Criteria
Not applicable.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Ecological Momentary Assessment (EMA) Training
Participants collect EMA data for 14 days to determine high-risk situations for smoking
2 weeks
Daily EMA surveys
Intervention
Participants receive tailored CBT and Mindfulness/ACT messages triggered by geofencing of high-risk locations
4 weeks
3 geofence-triggered EMAs per day
Follow-up
Participants are monitored for changes in smoking behavior and psychological flexibility
6 months
Assessments at 45-day, 3-month, and 6-month follow-up
Participant Groups
The study tests if messages sent through smartphones using cognitive behavioral therapy (CBT) or Mindfulness/Acceptance and Commitment Therapy (ACT) help young adults stop smoking. It focuses on sending support during high-risk situations that trigger the urge to smoke.
2Treatment groups
Experimental Treatment
Active Control
Group I: Micro-randomized trial groupExperimental Treatment1 Intervention
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).
Group II: EMA-only control groupActive Control1 Intervention
A total of N=80 participants will be randomized into an EMA-only control group, parallel to the micro-randomized trial intervention group. This group will conduct 14-day EMA only training phase just like the micro-randomized trial group, but will not be switched over to the intervention phase after these initial 14 days. Instead, participants will continue the EMA-only data collection procedure for an additional 30-days (analogous to the 30-day intervention phase of the micro-randomized trial). During these 30 days, the EMA-only control group will continue to receive 3 randomly prompted EMA surveys per day and an additional 3 EMA surveys triggered by smoking reports.
Smartphone-based intervention messages is already approved in United States, European Union, China, Canada, Japan, Switzerland for the following indications:
🇺🇸 Approved in United States as Smartphone-based messaging intervention for:
- Smoking cessation
🇪🇺 Approved in European Union as Mobile phone-based smoking cessation intervention for:
- Smoking cessation
🇨🇳 Approved in China as Text message-based smoking cessation intervention for:
- Smoking cessation
🇨🇦 Approved in Canada as Smartphone-based messaging intervention for:
- Smoking cessation
🇯🇵 Approved in Japan as Mobile phone-based smoking cessation intervention for:
- Smoking cessation
🇨🇭 Approved in Switzerland as Text message-based smoking cessation intervention for:
- Smoking cessation
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Johns Hopkins Bloomberg School of Public HealthBaltimore, MD
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Who Is Running the Clinical Trial?
Johns Hopkins Bloomberg School of Public HealthLead Sponsor
References
An ecological momentary intervention for smoking cessation: The associations of just-in-time, tailored messages with lapse risk factors. [2022]Smartphone apps can provide real-time, tailored interventions for smoking cessation. The current study examines the effectiveness of a smartphone-based smoking cessation application that assessed risk for imminent smoking lapse multiple times per day and provided messages tailored to current smoking lapse risk and specific lapse triggers.
Randomized trial of a smartphone mobile application compared to text messaging to support smoking cessation. [2022]Text messaging has successfully supported smoking cessation. This study compares a mobile application with text messaging to support smoking cessation.
Effectiveness of Mobile Apps for Smoking Cessation: A Review. [2020]Smartphone-based smoking cessation interventions are increasingly used around the world. However, the effects of smartphone applications on applicability and efficacy on cessation rate and prevention of relapses are not often evaluated. Therefore, this review aims to assess the evidence on effectiveness of smartphone applications as an intervention tool for smoking cessation support.
An Experimental Feasibility Study of a Hybrid Telephone Counseling/Text Messaging Intervention for Post-Discharge Cessation Support Among Hospitalized Smokers in Brazil. [2020]Text messaging interventions are effective. Despite high utilization of smartphones, few studies evaluate text messaging for cessation in middle-/lower-income countries. Initiating tobacco treatment in hospitals is an effective but underutilized approach for reaching smokers. We evaluated a hybrid phone counseling/text messaging intervention for supporting cessation among hospitalized smokers in Brazil.
Optimising text messaging to improve adherence to web-based smoking cessation treatment: a randomised control trial protocol. [2019]Millions of smokers use the Internet for smoking cessation assistance each year; however, most smokers engage minimally with even the best designed websites. The ubiquity of mobile devices and their effectiveness in promoting adherence in other areas of health behaviour change make them a promising tool to address adherence in Internet smoking cessation interventions. Text messaging is used by most adults, and messages can proactively encourage use of a web-based intervention. Text messaging can also be integrated with an Internet intervention to facilitate the use of core Internet intervention components.
Text messaging-based smoking cessation intervention: a narrative review. [2022]Smoking cessation interventions delivered via text messaging on mobile phones may enhance motivations to quit smoking. The goal of this narrative review is to describe the text messaging interventions' theoretical contents, frequency and duration, treatment outcome, and sample characteristics such as age and motivation to quit, to better inform the future development of this mode of intervention.
Efficacy of SMS Text Message Interventions for Smoking Cessation: A Meta-Analysis. [2022]Mobile technology provides new opportunities for health promotion communication. The purpose of this study was to conduct a current and extensive meta-analytic review of SMS (short message service) text message-based interventions for individual smoking cessation.
How do smokers use a smoking cessation text messaging intervention? [2018]Mobile-phone-based text (SMS) messaging is an effective method for delivering smoking cessation assistance; however, little is known about optimal program use. This paper reports on the use of 2 forms of interaction (reporting changes in quit status and emergency help) among users of QuitTxt, an interactive, automated text messaging advice program. We examined preferences for messaging intensity, duration of use, and their associations with short-term cessation outcome or perceived helpfulness.
Mobile phone-based interventions for smoking cessation. [2023]Access to mobile phones continues to increase exponentially globally, outstripping access to fixed telephone lines, fixed computers and the Internet. Mobile phones are an appropriate and effective option for the delivery of smoking cessation support in some contexts. This review updates the evidence on the effectiveness of mobile phone-based smoking cessation interventions.