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

Johns Hopkins Bloomberg School of Public Health

Status: Completed

Conditions: Tobacco Cigarette Smoking

Treatments: Behavioral: Smartphone-based intervention messages

Study type: Interventional

Funder types: Other

Identifiers

NCT05991934

IRB00013413-Pilot

IRB00013413

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 12 patients

Sex: All

Ages: 18 to 30 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. live in the U.S.
2. read English;
3. are between 18 and 30 years of age;
4. own an iPhone or Android smartphone;
5. have smoked ≥100 cigarettes and currently smoke at least 1 cigarette per day on 3 or more days of the week;
6. 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

12 participants in 1 patient group

Single arm pilot

Experimental group

Description:

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).

Treatment:

Behavioral: Smartphone-based intervention messages