Clinical trial NCT02968381: A Guided Imagery Tobacco Cessation Intervention Delivered by a Quit Line and Website
Official title: A Guided Imagery Tobacco Cessation Intervention Delivered by a Quit Line and Website
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tobacco Use
Smoking Cessation
Smoking, Tobacco
Tobacco Smoking
Guided Imagery
Keywords: tobacco
smoking
imagery
Lead sponsor: University of Arizona
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
name: West Virginia University
First posted: 2016-11-18
Enrollment: 121
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Number of Participants With Change in Self-reported 7-day Tobacco Abstinence From Baseline to Follow-up
timeFrame: 6 months
measure: Number of Participants With Change in Self-reported Tobacco 30-day Abstinence From Baseline to Follow-up
timeFrame: 6 months
Secondary outcomes:
measure: Change in Tobacco Use for Non-quitters From Baseline to Follow-up
timeFrame: 6 months
measure: Change in Self-efficacy for Quitting From Baseline to Follow-up
timeFrame: 6 months
measure: Change in Nicotine Cravings From Baseline to Follow-up
timeFrame: 6 months
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Arizona
state: Arizona
Study officials:
affiliation: University of Arizona
name: Judith Gordon, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.