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Ecological Momentary Intervention of Implementation Intentions Delivered by Text Message to Reduce Cigarette Smoking

Evaluation of an Ecological Momentary Intervention of Implementation Intentions Delivered by Text Message to Reduce Cigarette Smoking

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04967885
Enrollment
80
Registered
2021-07-20
Start date
2021-06-08
Completion date
2021-12-31
Last updated
2023-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cigarette Smoking

Keywords

Ecological Momentary Assessment, mHealth, Smoking, Implementation Intentions

Brief summary

This study will develop an ecological momentary implementation intentions intervention (EMI-II) for cigarette smoking, which will link critical situations where smoking is likely to occur with alternative responses to support avoidance of cigarette use. Using ecological momentary assessment (EMA) for data collection, this project will evaluate the feasibility, acceptability, and initial effectiveness of a micro-randomized trial (MRT) of EMI-II targeting cigarette smoking reduction in a sample of adults who smoke a minimum of 15 cigarettes per day (n=100).

Detailed description

Cigarette smoking accounts for nearly 1 in 5 preventable deaths in the United States, and reducing cigarette smoking has been suggested for those not yet ready to quit. Cigarette reduction has been shown to longitudinally predict eventual cessation. Evidence suggests that smoking is highly sensitive to environmental stimuli, so ecological momentary interventions (EMI) embedded within daily life may help reduce cigarette smoking. Within the context of EMIs, researchers have explored different strategies to support smoking cessation and reduction. Implementation interventions (II) is a novel self-regulatory strategy that may help individuals reduce smoking. In II, individuals identify critical situations where smoking is likely to occur, then develop and plan appropriate alternative responses to avoid cigarette use. When II is delivered as a brief, single session intervention, II increases cessation rates relative to control conditions. Although II is well-suited for EMI because the brief messages are designed to be contextually relevant, no known research has evaluated whether repeated administration of II delivered by EMI reduces cigarette use. EMI-II may be beneficial with greater exposure and when delivered in the contexts where a behavior, such as smoking, is likely to occur. This randomized controlled trial aims to test an ecological momentary implementation intentions intervention (EMI-II) to reduce cigarette smoking. This research seeks to identify in-the-moment intervention components that target momentary contextual and personal variables to effectively reduce cigarette smoking. Adults who smoke and are interested in reducing their cigarette use will be randomized to either the immediate intervention condition, or to a waitlist control. All participants will be followed for one month and will complete weekly surveys. Intervention participants will receive two weeks of the EMI-II with daily ecological momentary assessments (EMAs) in the two weeks post-randomization. Waitlist control participants will complete the weekly surveys for two weeks, then have access to the EMI-II with daily EMAs for two weeks. The daily EMAs are brief surveys in which participants report their current context and recent behavior and events. This project consists of two primary aims: Aim 1. To test the feasibility and acceptability of a customized, micro-randomized trial using EMI-II for smoking reduction. The investigators hypothesize that at least 75% of participants who start the EMI-II component will complete the two-week active study period. Also, the investigators hypothesize that participants will rate the acceptability of the EMI-II at least a 3.5 out of 5, on average. Aim 2. Test the initial effectiveness of EMI-II for reducing cigarette smoking. The investigators hypothesize that participants receiving EMI-II will show greater reductions in self-reported smoking than participants assigned to an EMA-only control. In addition, the investigators hypothesize that self-reported cigarette smoking during the next EMA following EMI-II presentation will be lower, relative to cigarette smoking reported in EMAs that do not proximally follow the EMI-II delivery.

Interventions

BEHAVIORALEcological Momentary Implementation Intentions Intervention (EMI-II)

To reduce smoking, this text messaging intervention will use a self-regulatory strategy, Implementation Intentions (II) to deliver appropriate alternative responses to cigarette smoking. Participants will create personalized II messages before starting the two-week intervention period. Then during the intervention period, after receiving Ecological Momentary Assessments (EMAs), participants will be micro-randomized to receive the EMI-II. During the EMA + EMI-II period, participants will complete five daily EMAs. After approximately 40% of these EMAs, participants will also receive the personalized EMI-II by text messaging.

Sponsors

National Institute on Drug Abuse (NIDA)
CollaboratorNIH
Trustees of Dartmouth College
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Intervention model description

Participants are randomly assigned to either the Immediate Intervention, or Waitlist conditions. The Immediate Intervention participants receive the Ecological Momentary Intervention plus Implementation Intentions (EMI-II) immediately after randomization for two weeks, followed by two weeks of surveys. The Waitlist participants complete two weeks of surveys, followed by two weeks of receiving the EMAs plus EMI-II.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 18 years of age or older * English-language proficient * Located in the United States * Self-reports smoking 15 or more cigarettes per day in the past week * Expresses interest in quitting or reducing smoking * Has a cell phone with access to text messaging * Willing to send and receive text messages related to smoking

Exclusion criteria

* Currently pregnant or plans to become pregnant * Currently on psychotropic medications for smoking cessation * Currently receiving behavioral treatment/therapy for smoking cessation

Design outcomes

Primary

MeasureTime frameDescription
Percent of Participants Completing Intervention Period2 weeksTo evaluate the feasibility of this customized EMI-II intervention, the investigators will examine the proportion of study participants completing the two-week intervention period, Week 2 in the Immediate Intervention arm and week 4 in the Waitlist arm.
Average Acceptability of the EMI-II Intervention2 weeksTo examine the acceptability of the EMI-II intervention, participants will rate the acceptability of the intervention on a Likert scale ranging from 1 (low acceptability) to 5 (high acceptability) on the two weekly surveys completed during the intervention period.
Rate of Self-reported Cigarette Smoking2 weeksSelf-reported cigarette smoking will be assessed five times per day (morning, late morning, early afternoon, late afternoon, evening) during the intervention period. Participants will respond via text messaging to the question, Since the last prompt, how many cigarettes have you smoked?

Countries

United States

Participant flow

Participants by arm

ArmCount
Immediate Intervention
Participants in the Immediate Intervention condition will create their Implementation Intention (II) messages before the two-week EMA + EMI-II period begins. During the EMA + EMI-II period, participants will complete five daily EMAs, and they will also complete weekly assessments reporting their past week cigarette smoking as a distal outcome and rating intervention acceptability. Following the EMA + EMI-II period, participants will enter a two-week follow-up period. During this time, participants will not receive any messages, but will report past week smoking on a weekly basis. Ecological Momentary Implementation Intentions Intervention (EMI-II): To reduce smoking, this text messaging intervention will use a self-regulatory strategy, Implementation Intentions (II) to deliver appropriate alternative responses to cigarette smoking. Participants will create personalized II messages before starting the two-week intervention period. Then during the intervention period, after receiving Ecological Momentary Assessments (EMAs), participants will be micro-randomized to receive the EMI-II. During the EMA + EMI-II period, participants will complete five daily EMAs. After approximately 40% of these EMAs, participants will also receive the personalized EMI-II by text messaging.
39
Waitlist
Participants randomized to the Waitlist control condition will begin with a two-week no intervention condition during which they will report past week smoking on a weekly basis but will not receive any other intervention components. At the end of the two-week waitlist control period, participants will begin the two-week EMA plus EMI-II period. During the EMA plus EMI-II active study period, participants will complete five daily EMAs and weekly assessments to report their past week cigarette smoking and rate intervention acceptability. No follow-up is planned for the wait list control condition. Ecological Momentary Implementation Intentions Intervention (EMI-II): To reduce smoking, this text messaging intervention will use a self-regulatory strategy, Implementation Intentions (II) to deliver appropriate alternative responses to cigarette smoking. Participants will create personalized II messages before starting the two-week intervention period. Then during the intervention period, after receiving Ecological Momentary Assessments (EMAs), participants will be micro-randomized to receive the EMI-II. During the EMA + EMI-II period, participants will complete five daily EMAs. After approximately 40% of these EMAs, participants will also receive the personalized EMI-II by text messaging.
41
Total80

Withdrawals & dropouts

PeriodReasonFG000FG001
EMI-II InterventionLost to Follow-up1410
Week 1 Follow-UpLost to Follow-up74
Week 2 Follow-UpLost to Follow-up146
Week 3 Follow-UpLost to Follow-up1611
Week 4 Follow-UpLost to Follow-up1610

Baseline characteristics

CharacteristicWaitlistImmediate InterventionTotal
Age, Continuous40.0 years
STANDARD_DEVIATION 1.7
42.6 years
STANDARD_DEVIATION 1.5
41.3 years
STANDARD_DEVIATION 1.1
Cigarettes smoker per day30.3 cigarettes smoked per day
STANDARD_DEVIATION 7.2
30.2 cigarettes smoked per day
STANDARD_DEVIATION 5.8
30.2 cigarettes smoked per day
STANDARD_DEVIATION 6.4
Ethnicity (NIH/OMB)
Hispanic or Latino
3 Participants2 Participants5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
38 Participants37 Participants75 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
5 Participants0 Participants5 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
1 Participants5 Participants6 Participants
Race (NIH/OMB)
More than one race
2 Participants1 Participants3 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
33 Participants33 Participants66 Participants
Region of Enrollment
United States
41 participants39 participants80 participants
Sex: Female, Male
Female
24 Participants31 Participants55 Participants
Sex: Female, Male
Male
17 Participants8 Participants25 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 390 / 41
other
Total, other adverse events
0 / 390 / 41
serious
Total, serious adverse events
0 / 390 / 41

Outcome results

Primary

Average Acceptability of the EMI-II Intervention

To examine the acceptability of the EMI-II intervention, participants will rate the acceptability of the intervention on a Likert scale ranging from 1 (low acceptability) to 5 (high acceptability) on the two weekly surveys completed during the intervention period.

Time frame: 2 weeks

Population: Includes participants who completed the AIM on the weekly surveys during the intervention period.

ArmMeasureValue (MEAN)Dispersion
Immediate InterventionAverage Acceptability of the EMI-II Intervention3.85 score on a scaleStandard Deviation 0.84
WaitlistAverage Acceptability of the EMI-II Intervention3.55 score on a scaleStandard Deviation 0.97
p-value: 0.24t-test, 2 sided
Primary

Percent of Participants Completing Intervention Period

To evaluate the feasibility of this customized EMI-II intervention, the investigators will examine the proportion of study participants completing the two-week intervention period, Week 2 in the Immediate Intervention arm and week 4 in the Waitlist arm.

Time frame: 2 weeks

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Immediate InterventionPercent of Participants Completing Intervention Period25 Participants
WaitlistPercent of Participants Completing Intervention Period31 Participants
Primary

Rate of Self-reported Cigarette Smoking

Self-reported cigarette smoking will be assessed five times per day (morning, late morning, early afternoon, late afternoon, evening) during the intervention period. Participants will respond via text messaging to the question, Since the last prompt, how many cigarettes have you smoked?

Time frame: 2 weeks

ArmMeasureValue (MEAN)Dispersion
Immediate InterventionRate of Self-reported Cigarette Smoking30.3 cigarettes smoked per dayStandard Deviation 7.1
WaitlistRate of Self-reported Cigarette Smoking30.1 cigarettes smoked per dayStandard Deviation 5

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026