Clinical Trials Directory

Trials / Completed

CompletedNCT02968381

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
121 (actual)
Sponsor
University of Arizona · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Accepted

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

Interventions

TypeNameDescription
BEHAVIORALImagery InterventionTelephone coaching sessions, use of guided imagery and website.
BEHAVIORALControl ConditionTelephone coaching using standard cognitive behavioral methods

Timeline

Start date
2018-05-01
Primary completion
2020-09-29
Completion
2022-01-21
First posted
2016-11-18
Last updated
2022-06-22
Results posted
2021-01-08

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT02968381. Inclusion in this directory is not an endorsement.