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

NCT04967885 | Completed Results

• 2 other identifiers: 108365P30DA029926
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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).

Conditions

Cigarette Smoking

Keywords

Ecological Momentary Assessment; mHealth; Smoking; Implementation Intentions

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (2)

Immediate Intervention

EXPERIMENTAL

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.

Behavioral: Ecological Momentary Implementation Intentions Intervention (EMI-II)

Waitlist

ACTIVE COMPARATOR

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.

Behavioral: Ecological Momentary Implementation Intentions Intervention (EMI-II)

Interventions

Ecological Momentary Implementation Intentions Intervention (EMI-II) BEHAVIORAL

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.

Immediate Intervention; Waitlist

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Trustees of Dartmouth College: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Center for Technology and Behavioral Health, Dartmouth College

Lebanon, New Hampshire, 03766, United States

Location

MeSH Terms

Conditions

Cigarette Smoking; Smoking

Condition Hierarchy (Ancestors)

Tobacco Smoking; Behavior; Tobacco Use

Limitations and Caveats

More than twenty percent of participants were lost to follow-up before completing the final study survey.

Results Point of Contact

• Title: Elizabeth Saunders
• Organization: Dartmouth College

elizabeth.c.saunders@dartmouth.edu

6036467006

Study Officials

• Elizabeth C Saunders, PhD

  Dartmouth College

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 8, 2021
• First Posted: July 20, 2021
• Study Start: June 8, 2021
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: April 24, 2023
• Results First Posted: March 27, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)