Clinical trial NCT04967885: Ecological Momentary Intervention of Implementation Intentions Delivered by Text Message to Reduce Cigarette Smoking
Official title: Evaluation of an Ecological Momentary Intervention of Implementation Intentions Delivered by Text Message to Reduce Cigarette Smoking
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cigarette Smoking
Keywords: Ecological Momentary Assessment
mHealth
Smoking
Implementation Intentions
Lead sponsor: Trustees of Dartmouth College
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2021-07-20
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percent of Participants Completing Intervention Period
timeFrame: 2 weeks
measure: Average Acceptability of the EMI-II Intervention
timeFrame: 2 weeks
measure: Rate of Self-reported Cigarette Smoking
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Center for Technology and Behavioral Health, Dartmouth College
state: New Hampshire
Study officials:
affiliation: Dartmouth College
name: Elizabeth C Saunders, PhD
role: PRINCIPAL_INVESTIGATOR
References: