Trial Outcomes & Findings for Testing the Impact of Smartphone-based Messaging to Support Young Adult Smoking Cessation - Pilot (NCT NCT05991934)

NCT ID: NCT05991934

Last Updated: 2025-05-20

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

12 participants

Primary outcome timeframe

Baseline, 15 minutes after message delivery

Results posted on

2025-05-20

Participant Flow

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.

Participant milestones

Participant milestones
Measure	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).
Overall Study STARTED	12
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Single Arm Pilot n=12 Participants 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).
Age, Continuous	24.3 years STANDARD_DEVIATION 3.4 • n=99 Participants
Sex: Female, Male Female	7 Participants n=99 Participants
Sex: Female, Male Male	5 Participants n=99 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=99 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	10 Participants n=99 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants
Race (NIH/OMB) Asian	1 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	3 Participants n=99 Participants
Race (NIH/OMB) White	6 Participants n=99 Participants
Race (NIH/OMB) More than one race	2 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants

PRIMARY outcome

Timeframe: Baseline, 15 minutes after message delivery

Population: 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.

Outcome measures

Outcome measures
Measure	Single Arm Pilot n=291 Message exposures 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).
Smoking Urge as Assessed by Survey Item Control: Pre-message EMA, smoking urge	2.59 units on a scale Standard Deviation 1.30
Smoking Urge as Assessed by Survey Item Control: Follow-up EMA, smoking urge	2.39 units on a scale Standard Deviation 1.27
Smoking Urge as Assessed by Survey Item CBT: Pre-message EMA, smoking urge	2.53 units on a scale Standard Deviation 1.50
Smoking Urge as Assessed by Survey Item CBT: Follow-up EMA, smoking urge	2.16 units on a scale Standard Deviation 1.35
Smoking Urge as Assessed by Survey Item ACT: Pre-message EMA, smoking urge	2.76 units on a scale Standard Deviation 1.34
Smoking Urge as Assessed by Survey Item ACT: Follow-up EMA, smoking urge	2.40 units on a scale Standard Deviation 1.30

PRIMARY outcome

Timeframe: Baseline, 45-day follow-up

The primary outcome will be change in self-reported number of cigarettes smoked per day in the past week from baseline to 45-days.

Outcome measures

Outcome measures
Measure	Single Arm Pilot n=8 Participants 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).
Change in Number of Cigarettes Smoked Per Day in Past Week as Assessed by a Single Item Baseline	7.1 Cigarettes per day Standard Deviation 5.8
Change in Number of Cigarettes Smoked Per Day in Past Week as Assessed by a Single Item 45-day follow-up	3.2 Cigarettes per day Standard Deviation 2.2

Adverse Events

Single Arm Pilot

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Johannes Thrul, PhD

Johns Hopkins Bloomberg School of Public Health

Phone: (443) 318-6633‬

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place