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

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.

Study Overview

• Status: Completed
• Conditions: Smoking; Smoking Cessation; Smoking Reduction; Smoking, Cigarette; Smoking Habit; Smoking (Tobacco) Addiction
• Intervention / Treatment: Other: Guided Imagery Intervention; Other: Standard Behavioral Control

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 1209
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85714
      • University of Arizona

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Report daily smoking in the last 30 days
• Age 18 or over
• Speak English
• Have a smart phone with internet access
• Willing to receive coaching over the phone

Exclusion Criteria:

• No phone
• No internet access
• Does not speak English
• More than one person per household
• Psychosis

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Guided Imagery Intervention	Other: Guided Imagery Intervention; Participants in the Guided Imagery Intervention receive 6 sessions of a Guided Imagery plus standard smoking cessation coaching over 6 weeks, delivered by telephone. Sessions range from 10 - 60 minutes, and cover reasons for and benefits of quitting, triggers and alternative strategies, coping with cravings, withdrawal and NRT, and relapse prevention. In each session, coaches work with participants to create or revise guided imagery scripts. After the session, coaches record the script as a digital audio file and send to the participant. Participants listen to their audio file every day and practice behavioral skills between sessions.
Active Comparator: Standard Behavioral Control	Other: Standard Behavioral Control; Participants in the Standard Behavioral Control condition receive 6 sessions of a standard smoking cessation coaching over 6 weeks, delivered by telephone. Sessions range from 10 - 60 minutes, and cover reasons for and benefits of quitting, triggers and alternative strategies, coping with cravings, withdrawal and NRT, and relapse prevention. In each session, coaches work with participants to identify lifestyle changes to support tobacco cessation, and set a schedule for practicing new behavioral strategies. Participants complete exercises in a quit booklet every day and practice behavioral skills between sessions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants who achieve biochemically verified 7 day smoking abstinence	Smoking abstinence will be biochemically verified with expired carbon monoxide	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants who report 7 day smoking abstinence	Participants will self-report tobacco use	Baseline, 3 months, and 6 months
Number of participants who report 30 day smoking abstinence	Participants will self-report tobacco use	Baseline, 3 months, and 6 months
Number of minutes of intervention use per week	Number of minutes participants engage in study sessions per week	Week 1, Week 2, Week 3, Week 4, Week 5, Week 6
Number of minutes guided imagery and other integrative skills practiced per day	Participants will self-report number of minutes guided imagery and other integrative skills practiced per day for the past 7 days	3 months, 6 months
Number of intervention sessions attended		Week 1, Week 2, Week 3, Week 4, Week 5, Week 6

Collaborators and Investigators

• Sponsor: University of Arizona
• Collaborators: National Center for Complementary and Integrative Health (NCCIH)

Publications and helpful links

General Publications

• Gordon JS, Armin JS, Giacobbi P Jr, Hsu CH, Marano K, Sheffer CE. Testing the Efficacy of a Scalable Telephone-Delivered Guided Imagery Tobacco Cessation Treatment: Protocol for a Randomized Clinical Trial. JMIR Res Protoc. 2023 Jun 23;12:e48898. doi: 10.2196/48898.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2022
• Primary Completion (Actual): October 26, 2025
• Study Completion (Actual): October 26, 2025

Study Registration Dates

• First Submitted: February 14, 2022
• First Submitted That Met QC Criteria: March 3, 2022
• First Posted (Actual): March 14, 2022

Study Record Updates

• Last Update Posted (Actual): November 24, 2025
• Last Update Submitted That Met QC Criteria: November 18, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Compulsive Behavior; Impulsive Behavior; Behavior; Health Behavior; Tobacco Smoking; Tobacco Use; Behavior, Addictive; Smoking; Smoking Cessation; Cigarette Smoking; Smoking Reduction
• Other Study ID Numbers: 2103633455; R01AT011500 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No