A Guided Imagery Tobacco Cessation Intervention Delivered by a Quit Line and Website

NCT ID: NCT02968381

Last Updated: 2022-06-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 121 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-01
• Study Completion Date: 2022-01-21

Brief Summary

Tobacco use is still the leading cause of preventable disease and death in the United States. Tobacco quit lines are effective at helping smokers to quit, but quit lines are underutilized, especially by men and racial/ethnic minorities. Guided imagery is effective at helping people quit smoking, and is appealing to males and diverse racial groups, but has limited reach. The proposed study will develop and test the feasibility and acceptability of a guided imagery tobacco cessation intervention that is delivered by a combination of quit line coaches and an interactive website. The investigators hypothesize that guided mental imagery delivered using the quit line "coaching model" combined with an interactive website could be an effective intervention strategy.

Detailed Description

The objective of this three year R34 application is to develop and test the feasibility of a theory-driven, telephone plus web-based, guided mental imagery intervention for smoking cessation.

Aim 1. Develop a theory-based, guided mental imagery tobacco cessation intervention for quit line callers with input from expert consultants in health disparities and a Community Advisory Board representing diverse populations and tobacco control stakeholders. The intervention will include phone-based coaching, an interactive website, and optional cessation medication. It will be focus tested with 40 smokers (from diverse racial/ethnic and age groups with at least 40% males), and usability tested with 5 smokers.

Aim 2. Develop training and competency standards for, and train, four coaches in the implementation of the guided imagery and control interventions. Coaches will be assessed at 6-weeks and 6-months post-training for implementation fidelity and satisfaction.

Aim 3. Conduct a feasibility trial (N=100) to gather preliminary data on the effects of the guided mental imagery intervention on quit line callers' tobacco use, cravings, and self-efficacy to quit smoking, and to refine study procedures, including recruitment, retention, and use of intervention components. Participants will be randomly assigned to receive either the Imagery Intervention (N=50) or an attention control condition (N=50) as delivered by study coaches. Participants will be assessed at baseline, 6-weeks and 6-months post-enrollment. Primary outcomes will be self-reported point prevalence and prolonged abstinence of tobacco use. Biochemical validation will be conducted on a sub-sample to determine validity of self-reported abstinence in this population. Secondary outcomes will be self-reported cravings and self-efficacy.

Conditions

Tobacco Use; Smoking Cessation; Smoking, Tobacco; Tobacco Smoking; Guided Imagery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Imagery Intervention

Participants will receive imagery intervention which includes 6 telephone sessions, an introduction to guided imagery, setting a quit date, setting guided imagery schedule, and a description of and instructions for using the study website.

Group Type: EXPERIMENTAL

Imagery Intervention

Intervention Type: BEHAVIORAL

Telephone coaching sessions, use of guided imagery and website.

Control Condition

Participants will receive an attention control condition which includes 6 telephone sessions, an introduction to cognitive behavioral telephone coaching, setting a quit date, creating a quit plan, and a description of and instructions for using the Arizona Smokers' Help Line website.

Group Type: ACTIVE_COMPARATOR

Control Condition

Intervention Type: BEHAVIORAL

Telephone coaching using standard cognitive behavioral methods

Interventions

Imagery Intervention

Telephone coaching sessions, use of guided imagery and website.

Intervention Type: BEHAVIORAL

Control Condition

Telephone coaching using standard cognitive behavioral methods

Intervention Type: BEHAVIORAL

Other Intervention Names

Active Comparator

Eligibility Criteria

Inclusion Criteria

• Current smoker trying to quit
• Speak English
• Internet access
• Email access
• Live in the state of Arizona, USA

Exclusion Criteria

• Having enrolled and participated in Quit line services in the past 12 months
• Diagnosed with a serious mental illness (e.g. current depression)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role: collaborator

West Virginia University

OTHER

Sponsor Role: collaborator

University of Arizona

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Judith Gordon, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Arizona

Locations

University of Arizona

Tucson, Arizona, United States

Countries

United States

References

Gordon JS, Bell ML, Armin JS, Giacobbi PR, Nair US. A telephone-based guided imagery tobacco cessation intervention: results of a randomized feasibility trial. Transl Behav Med. 2021 Mar 16;11(2):516-529. doi: 10.1093/tbm/ibaa052.

Reference Type: DERIVED

PMID: 32542352 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

http://SeeMeSmokeFree.com

Pilot project using guided imagery for tobacco cessation for women concerned about weight gain

Other Identifiers

1R34AT008947

Identifier Type: NIH

Identifier Source: secondary_id

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1R34AT008947

Identifier Type: NIH

Identifier Source: org_study_id

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