Smoking CessationNCT05277831
Testing the Efficacy of A Scalable, Telephone-Delivered, Guided Imagery Tobacco Cessation Intervention
A study testing Guided Imagery Intervention in people with Smoking Cessation and Smoking, run by University of Arizona at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation, Smoking, Smoking Reduction
- What is being tested?
- Guided Imagery Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,209 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2022to 26 Oct 2025
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- No phone
- No internet access
- Does not speak English
- More than one person per household
- Psychosis
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed 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.
- Conditions
- Smoking Cessation, Smoking, Smoking Reduction, Smoking, Cigarette, Smoking (Tobacco) Addiction, Smoking Habit
- Being tested
- Guided Imagery Intervention, Standard Behavioral Control
- Medical subject headings
- Smoking Cessation, Smoking, Smoking Reduction, Cigarette Smoking, Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guided Imagery InterventionOther
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 ControlOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Guided Imagery Intervention | Experimental | Guided Imagery Intervention Receives: Other: Guided Imagery Intervention |
| Standard Behavioral Control | Active comparator | Standard Behavioral Control Receives: Other: Standard Behavioral Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who report 30 day smoking abstinence
Participants will self-report tobacco use
Measured: Baseline, 3 months, and 6 months
Secondary outcomes (5)
Number of participants who report 7 day smoking abstinence
Participants will self-report tobacco use
Measured: Baseline, 3 months, and 6 months
Number of participants who achieve biochemically verified 7 day smoking abstinence
Smoking abstinence will be biochemically verified with expired carbon monoxide
Measured: 6 months
Number of minutes of intervention use per week
Number of minutes participants engage in study sessions per week
Measured: 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
Measured: 3 months, 6 months
Number of intervention sessions attended
Measured: Week 1, Week 2, Week 3, Week 4, Week 5, Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2022
- Study start1 Aug 2022
- Primary completion26 Oct 2025
- Study completion26 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 1,209 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Principal investigator, Judith S. Gordon, PhD, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05277831
- Sponsor's protocol ID
- 2103633455
- Other IDs
- R01AT011500
- Status last verified
- Oct 2026
- First submitted
- 14 Feb 2022
- Last updated
- 16 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Coffee Z, Hsu CH, Sheffer CE, Giacobbi P Jr, Marano KM, Barraza Y, Gordon JS. Factors associated with enrollment, adherence, and retention in a remotely delivered tobacco cessation randomized controlled trial. Tob Prev Cessat. 2026 Jun 30;12. doi: 10.18332/tpc/216719. eCollection 2026.
PubMed 42427924Gordon JS, Armin JS, Giacobbi P Jr, Hsu CH, Marano K, Sheffer CE. Testing the Efficacy of a Scalable Telephone-Delivered Guided Imagery Tobacco Cessation Treatment: Protocol for a Randomized Clinical Trial. JMIR Res Protoc. 2023 Jun 23;12:e48898. doi: 10.2196/48898.
PubMed 37351932