Testing the Efficacy of A Scalable, Telephone-Delivered, Guided Imagery Tobacco Cessation Intervention

Smoking Cessation Clinical Trial

Official title: Testing the Efficacy of A Scalable, Telephone-Delivered, Guided Imagery Tobacco Cessation Intervention

Status Recruiting

Clinical Trial Summary

The objective of this R01 application is to conduct a randomized controlled trial to test the efficacy of the Be Smoke Free, telephone-based, guided imagery (GI) intervention (IC) for smoking cessation compared to active behavioral control (CC). The study will recruit 1,200 diverse smokers from three states, Arizona, New York, and West Virginia to increase generalizability. Participants will be randomly assigned to receive either the IC or CC delivered by telephone by University of Arizona study coaches and will be assessed at 3- and 6-months post-enrollment by study staff. The primary outcome is biochemically verified 7-day point prevalence abstinence at 6 months. This innovative and rigorously designed project conducted by an experienced team has the potential to improve public health through the delivery of an innovative integrative GI intervention via telephone.

Clinical Trial Description

The Specific Aims of the proposed study are to:

Aim 1: Test the efficacy of a telephone-delivered, integrative GI tobacco cessation intervention (IC) vs. an active behavioral control (CC) on biochemically verified 7-day point prevalence and self-reported 30-day smoking abstinence at 6 months post-enrollment. Four weeks of nicotine replacement therapy (NRT) will be included in both conditions. The investigators will assess self-reported 7-day and 30-day tobacco use at baseline, and 3- and 6-months post-enrollment. Our primary outcome is biochemically verified 7-day point prevalence abstinence at 6 months using the Smokerlyzer iCO expired CO monitor.

H1: Participants in the IC will have 10% higher quit rates than those in the CC. A 10% increase is clinically meaningful on a population level. A sample size of 1200 will provide 90% power to detect a 10% increase over a control condition quit rate of 30% with 20% missing data.

Aim 2: Conduct dose-response analyses on the effect of IC adherence (measured by self-reported minutes of intervention use per week, number of times GI skills practiced per weeks, number of sessions attended, and coach-rated participant engagement in sessions) on abstinence at 6 months. The investigators will also examine effects of the IC and CC on tobacco use for those participants who do not report abstinence at 6-months.

H2A: IC participants who are more adherent will have higher rates of biochemically verified abstinence.

H2B: IC and CC participants who do not report abstinence will report significant reductions in tobacco use.

Aim 3: Conduct subgroup analyses of moderators (e.g., phone type/plan, recruitment method, location, sex, race/ethnicity, level of dependence) on tobacco cessation outcomes at 6 months, and assess participants using a mixed-methods approach (e.g., surveys, in-depth interviews) for exploring sub-group differences. This innovative and rigorously designed project conducted by an experienced team has the potential to improve public health through the delivery of an innovative integrative GI intervention via telephone. If successful, this intervention model could be expanded to address other forms of tobacco and e-cigarettes. ;

Related Conditions & MeSH terms

• Behavior, Addictive
• Smoking
• Smoking (Tobacco) Addiction
• Smoking Cessation
• Smoking Habit
• Smoking Reduction
• Smoking, Cigarette

• NCT number: NCT05277831
• Study type: Interventional
• Source: University of Arizona
• Contact: Judith S Gordon, PhD
• Phone: 520-626-4970
• Email: judithg@arizona.edu
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2022
• Completion date: August 31, 2026