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

Cigarette Smoking Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04967885
• Other study ID #: 10836
• Secondary ID: 5P30DA029926
• Status: Completed
• Phase: N/A
• Start date: June 8, 2021
• Est. completion date: December 31, 2021

Study information

• Verified date: March 2023
• Source: Trustees of Dartmouth College
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cigarette Smoking

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Center for Technology and Behavioral Health, Dartmouth College	Lebanon	New Hampshire

Sponsors (2)

Lead Sponsor	Collaborator
Trustees of Dartmouth College	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	2 weeks
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.	2 weeks
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?"	2 weeks