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

NCT05277831 | Completed

• 2 other identifiers: 2103633455R01AT011500
• Study Type: interventional
• Target: 1,209
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Smoking Cessation; Smoking; Smoking Reduction; Smoking, Cigarette; Smoking (Tobacco) Addiction; Smoking Habit

Outcome Measures

Primary Outcomes (1)

• Number of participants who achieve biochemically verified 7 day smoking abstinence

  Smoking abstinence will be biochemically verified with expired carbon monoxide

  6 months

Secondary Outcomes (5)

• Number of participants who report 7 day smoking abstinence

  Baseline, 3 months, and 6 months

• Number of participants who report 30 day smoking abstinence

  Baseline, 3 months, and 6 months

• Number of minutes of intervention use 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

  3 months, 6 months

• Number of intervention sessions attended

  Week 1, Week 2, Week 3, Week 4, Week 5, Week 6

Study Arms (2)

Guided Imagery Intervention

EXPERIMENTAL

Guided Imagery Intervention

Other: Guided Imagery Intervention

Standard Behavioral Control

ACTIVE COMPARATOR

Standard Behavioral Control

Other: Standard Behavioral Control

Interventions

Guided Imagery Intervention OTHER

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.

Guided Imagery Intervention

Standard Behavioral Control OTHER

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.

Standard Behavioral Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Arizona: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

University of Arizona

Tucson, Arizona, 85714, United States

Location

Related Publications (1)

• 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.

  PMID: 37351932 DERIVED

MeSH Terms

Conditions

Smoking Cessation; Smoking; Smoking Reduction; Cigarette Smoking; Behavior, Addictive

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Tobacco Smoking; Tobacco Use; Compulsive Behavior; Impulsive Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Associate Dean for Research

Study Record Dates

• First Submitted: February 14, 2022
• First Posted: March 14, 2022
• Study Start: August 1, 2022
• Primary Completion: October 26, 2025
• Study Completion: October 26, 2025
• Last Updated: November 24, 2025

Record last verified: 2025-11

Locations

US (1)