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

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University of Arizona

Status

Enrolling

Conditions

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

Treatments

Other: Standard Behavioral Control
Other: Guided Imagery Intervention

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT05277831
2103633455
R01AT011500 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

1,200 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

None (Open label)

1,200 participants in 2 patient groups

Guided Imagery Intervention
Experimental group
Description:
Guided Imagery Intervention
Treatment:
Other: Guided Imagery Intervention
Standard Behavioral Control
Active Comparator group
Description:
Standard Behavioral Control
Treatment:
Other: Standard Behavioral Control

Trial contacts and locations

1

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Central trial contact

Judith S Gordon, PhD

Data sourced from clinicaltrials.gov

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