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

Study Overview
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Brief Summary
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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.

Detailed Description
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The Specific Aims of the proposed study are to: Aim 1: Test the efficacy of a telephone-delivered, integrative GI tobacco cessation intervention (IC) vs. an active behavioral control (CC) on biochemically verified 7-day point prevalence and self-reported 30-day smoking abstinence at 6 months post-enrollment. Four weeks of nicotine replacement therapy (NRT) will be included in both conditions. The investigators will assess self-reported 7-day and 30-day tobacco use at baseline, and 3- and 6-months post-enrollment. Our primary outcome is biochemically verified 7-day point prevalence abstinence at 6 months using the Smokerlyzer iCO expired CO monitor. H1: Participants in the IC will have 10% higher quit rates than those in the CC. A 10% increase is clinically meaningful on a population level. A sample size of 1200 will provide 90% power to detect a 10% increase over a control condition quit rate of 30% with 20% missing data. Aim 2: Conduct dose-response analyses on the effect of IC adherence (measured by self-reported minutes of intervention use per week, number of times GI skills practiced per weeks, number of sessions attended, and coach-rated participant engagement in sessions) on abstinence at 6 months. The investigators will also examine effects of the IC and CC on tobacco use for those participants who do not report abstinence at 6-months. H2A: IC participants who are more adherent will have higher rates of biochemically verified abstinence. H2B: IC and CC participants who do not report abstinence will report significant reductions in tobacco use. Aim 3: Conduct subgroup analyses of moderators (e.g., phone type/plan, recruitment method, location, sex, race/ethnicity, level of dependence) on tobacco cessation outcomes at 6 months, and assess participants using a mixed-methods approach (e.g., surveys, in-depth interviews) for exploring sub-group differences. 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. If successful, this intervention model could be expanded to address other forms of tobacco and e-cigarettes.

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

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

Intervention / Treatment
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* Other: Guided Imagery Intervention
* Other: Standard Behavioral Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: No phone No internet access Does not speak English More than one person per household Psychosis

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Guided Imagery Intervention<br>Guided Imagery Intervention | Other: Guided Imagery Intervention<br>* 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.<br>|
| Active Comparator: Standard Behavioral Control<br>Standard Behavioral Control | Other: Standard Behavioral Control<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants who achieve biochemically verified 7 day smoking abstinence | Smoking abstinence will be biochemically verified with expired carbon monoxide | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants who report 7 day smoking abstinence | Participants will self-report tobacco use | Baseline, 3 months, and 6 months | 
| Number of participants who report 30 day smoking abstinence | Participants will self-report tobacco use | Baseline, 3 months, and 6 months | 
| Number of minutes of intervention use per week | Number of minutes participants engage in study sessions 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 | Participants will self-report number of minutes guided imagery and other integrative skills practiced per day for the past 7 days | 3 months, 6 months | 
| Number of intervention sessions attended |  | Week 1, Week 2, Week 3, Week 4, Week 5, Week 6 |