Testing the Efficacy of A Scalable, Telephone-Delivered, Guided Imagery Tobacco Cessation Intervention
NCT05277831 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1209
Last updated 2025-11-24
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
Interventions
- 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.
- 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.
Sponsors & Collaborators
-
National Center for Complementary and Integrative Health (NCCIH)
collaborator NIH -
University of Arizona
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- FACTORIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2022-08-01
- Primary Completion
- 2025-10-26
- Completion
- 2025-10-26
Countries
- United States
Study Locations
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