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

Smoking Cessation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05277831
• Other study ID #: 2103633455
• Secondary ID: R01AT011500
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2022
• Est. completion date: August 31, 2026

Study information

• Verified date: September 2023
• Source: University of Arizona
• Contact: Judith S Gordon, PhD
• Phone: 520-626-4970
• Email: judithg[@]arizona.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1200
• Est. completion date: August 31, 2026
• Est. primary completion date: August 31, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Behavior, Addictive
• Smoking
• Smoking (Tobacco) Addiction
• Smoking Cessation
• Smoking Habit
• Smoking Reduction
• Smoking, Cigarette

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Arizona	Tucson	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
University of Arizona	National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants who achieve biochemically verified 7 day smoking abstinence	Smoking abstinence will be biochemically verified with expired carbon monoxide	6 months
Secondary	Number of participants who report 7 day smoking abstinence	Participants will self-report tobacco use	Baseline, 3 months, and 6 months
Secondary	Number of participants who report 30 day smoking abstinence	Participants will self-report tobacco use	Baseline, 3 months, and 6 months
Secondary	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
Secondary	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
Secondary	Number of intervention sessions attended		Week 1, Week 2, Week 3, Week 4, Week 5, Week 6