JMIR Publications

ABSTRACT

Background:

Tobacco use continues to be a leading preventable cause of death and disease in the United States accounting for over 480,000 deaths each year. While evidence-based treatments for tobacco use are effective for many, there is substantial variability in outcomes and these approaches are not effective for all individuals seeking to quit smoking cigarettes. New, effective therapeutic approaches are needed to meet the needs and preferences of people who want to stop smoking. Guided Imagery is a mind-body technique that involves the guided visualization of specific mental images that is enhanced with other sensory modalities and emotions. Preliminary evidence provides initial support for the use of Guided Imagery as a treatment for cigarette smoking. Multiple meta-analyses have shown that standard, evidence-based treatment for cigarette smoking delivered over the phone via quitlines is effective. An effective, telephone-based, intervention that utilizes Guided Imagery might provide another effective treatment option and increase the reach and effectiveness of quitlines.

Objective:

To test the efficacy of the Be Smoke Free, a telephone-delivered, Guided Imagery treatment for smoking cessation.

Methods:

This multi-site randomized clinical trial (RCT) will compare a novel, telephone-delivered, Guided Imagery tobacco cessation treatment with a standard, evidence-based behavioral treatment for smoking cessation. The study will be conducted over five years. In Phase 1, we refined protocols and procedures for the New York and West Virginia sites for use in the RCT. During Phase 2, we will conduct an RCT with 1,200 participants; 600 recruited via quitlines and 600 via population-based methods. Participants will be randomly assigned to either the Guided Imagery condition (GIC) or behavioral condition (BC). Both the GIC and BC treatments will be delivered by trained study coaches located at the University of Arizona (UA). Assessments will be conducted at baseline, and 3- and 6-months post-enrollment by UA research staff. The primary outcome will be self-reported 30-day point prevalence abstinence at 6 months post-enrollment. Secondary outcomes include biochemically verified 7-day point prevalence abstinence 6 months post-enrollment.

Results:

Recruitment in West Virginia and New York State began in October 2022. As of 3/31/2023, 242 participants were enrolled. Follow-up assessments began in November 2022. As of March 31, 2023, 97 (82.2%) had completed the 3-month and 26 (92.9%) the 6-month assessment. Biochemical verification and qualitative interviews began in April 2023. Recruitment will continue through 2025 and follow-up assessments through 2026. Primary results are expected to be published in 2027.

Conclusions:

The Be Smoke Free study is a first-of-its-kind RCT that incorporates Guided Imagery into telephone-based tobacco cessation treatment. If successful, Be Smoke Free will have substantial benefits to the long-term health of people who use tobacco across the United States. Clinical Trial: ClinicalTrials.gov [NCT05277831]