Telephone-Delivered Guided Imagery for Smoking Cessation

Overseen By Judith S Gordon, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Arizona

Disqualifiers: No phone, No internet, Psychosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 6 months

1200 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It focuses on smoking cessation through guided imagery delivered by phone.

What data supports the effectiveness of the treatment Telephone-Delivered Guided Imagery for Smoking Cessation?

Research suggests that guided imagery, a technique using mental visualization, can help people quit smoking. When combined with telephone quitlines, which are already effective for smoking cessation, guided imagery may offer an alternative approach that could reach more people, including those who don't typically use quitlines. ^{1 2 3 4 5}

Is telephone-delivered guided imagery for smoking cessation safe for humans?

The research does not provide specific safety data for telephone-delivered guided imagery for smoking cessation, but guided imagery is generally considered a safe mind-body technique. ^{1 2 3 4 5}

How is the guided imagery treatment for smoking cessation different from other treatments?

Guided imagery for smoking cessation is unique because it uses the imagination to visualize desired outcomes and is delivered over the phone, making it accessible to people who may not use traditional quitline services. This approach can appeal to under-served groups and those seeking an alternative to standard behavioral interventions. ^{1 2 3 4 5}

Eligibility Criteria

This trial is for English-speaking adults over 18 who smoke daily and are willing to receive phone coaching. They must have a smartphone with internet access. It's not for those without a phone or internet, non-English speakers, households with more than one participant, or individuals with psychosis.

Inclusion Criteria

Speak English

Have a smart phone with internet access

I am open to getting phone coaching.

Exclusion Criteria

No phone

Psychosis

More than one person per household

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a telephone-delivered guided imagery intervention or standard behavioral control, with 4 weeks of nicotine replacement therapy included in both conditions

6 months

Weekly sessions (telephone)

Follow-up

Participants are monitored for smoking abstinence and tobacco use reduction at 3 and 6 months post-enrollment

6 months

Assessments at 3 and 6 months (telephone)

Treatment Details

Interventions

• Guided Imagery Intervention
• Standard Behavioral Control

Trial Overview The study tests a telephone-delivered guided imagery program against standard behavioral control to help people quit smoking. Participants from Arizona, New York, and West Virginia will be randomly assigned to either the guided imagery intervention or the control group.

Participant Groups

Group I: Guided Imagery Intervention Experimental Treatment 1 Intervention

Guided Imagery Intervention

Group II: Standard Behavioral Control Active Control 1 Intervention

Standard Behavioral Control

Guided Imagery Intervention is already approved in United States for the following indications:

Approved in United States as Guided Imagery Intervention for:

• Smoking cessation

Who Is Running the Clinical Trial?

University of Arizona

Lead Sponsor

Trials

545

Recruited

161,000+

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Trials

886

Recruited

677,000+

Findings from Research

A guided imagery-based intervention for smoking cessation was found to be feasible and acceptable, with high retention (81.9%) and adherence (66.7%) rates among 105 participants over a 6-month period.

Quit rates were promising, with 27.9% for the guided imagery group and 38.1% for the control group, indicating that this approach could be a valuable addition to traditional quitline services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A telephone-based guided imagery tobacco cessation intervention: results of a randomized feasibility trial. Gordon, JS., Bell, ML., Armin, JS., et al.[2021]

The study aims to evaluate the feasibility of a guided imagery (GI) intervention for tobacco cessation delivered via telephone, targeting a diverse group of smokers, including underrepresented minorities.

With 100 participants randomized to either the GI or a standard behavioral intervention over a 6-week period, the study will assess recruitment, retention, and adherence, as well as smoking cessation rates at 6 months, potentially offering a scalable alternative to traditional quitlines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Testing the feasibility of a guided imagery tobacco cessation intervention delivered by a telephone quitline: Study protocol for a randomized controlled feasibility trial. Gordon, JS., Giacobbi, P., Armin, JS., et al.[2023]

The Be Smoke Free study is a novel randomized clinical trial testing the efficacy of a telephone-delivered guided imagery (GI) treatment for smoking cessation, involving 1200 participants over 5 years, aiming to improve quit rates compared to standard behavioral treatments.

Initial recruitment has begun, with 242 participants enrolled as of March 2023, and follow-up assessments showing high completion rates, indicating strong engagement and potential for effective long-term tobacco cessation support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Testing the Efficacy of a Scalable Telephone-Delivered Guided Imagery Tobacco Cessation Treatment: Protocol for a Randomized Clinical Trial. Gordon, JS., Armin, JS., Giacobbi, P., et al.[2023]

A new guided imagery-based smoking cessation program is being developed to engage smokers who typically do not use traditional quitline services, particularly targeting men and racial/ethnic minorities.

The program's development involved extensive feedback from 46 participants in small group interviews and pilot testing with 5 smokers, ensuring that the materials are relevant and appealing to underserved populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing a Guided Imagery Telephone-Based Tobacco Cessation Program for a Randomized Controlled Trial. Armin, JS., Nair, U., Giacobbi, P., et al.[2023]

In a study involving 71 adult smokers, those who used guided imagery techniques had a significantly higher smoking abstinence rate of 26% after 24 months compared to 12% in the control group.

The intervention included daily practice of guided imagery, suggesting that this mental technique can be an effective tool for long-term smoking cessation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Guided health imagery for smoking cessation and long-term abstinence. Wynd, CA.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

A telephone-based guided imagery tobacco cessation intervention: results of a randomized feasibility trial. [2021]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Testing the feasibility of a guided imagery tobacco cessation intervention delivered by a telephone quitline: Study protocol for a randomized controlled feasibility trial. [2023]

3. Canada pubmed.ncbi.nlm.nih.gov

Testing the Efficacy of a Scalable Telephone-Delivered Guided Imagery Tobacco Cessation Treatment: Protocol for a Randomized Clinical Trial. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Developing a Guided Imagery Telephone-Based Tobacco Cessation Program for a Randomized Controlled Trial. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Guided health imagery for smoking cessation and long-term abstinence. [2022]