Community-based Smoking Cessation Treatment for Adults With High Stress Sensitivity.

Official title

Efficacy and Implementation of Exercise-based Smoking Cessation Treatment for Adults With High Anxiety Sensitivity.

Overview

Anxiety sensitivity, reflecting the fear of bodily sensations, is a risk factor for the maintenance and relapse of smoking. This study is designed to address the question - is a smoking cessation intervention personalized to high anxiety sensitive smokers and adapted for implementation by the YMCA effective among racially/ethnically diverse samples?

Detailed description

This protocol provides the recommended treatment to achieve smoking cessation (i.e., counseling and nicotine replacement therapy) and randomly assigns individuals to a high-intensity exercise or low-intensity exercise intervention as a strategy to engage the mechanisms relevant to high anxiety sensitive smokers to improve smoking cessation outcomes.

Interventions

• Behavioral Aerobic Exercise
  Participants will select a YMCA branch and will be assigned a personal fitness instructor who will oversee a 15-week exercise intervention. The weekly exercise prescription is 75 minutes of aerobic training.
• Behavioral Counseling
  Participants will receive the standard tobacco cessation package of up to 5 proactive interactions from the Texas Tobacco Quitline (TTQ). Interactions are typically phone calls, but can be chat or live text if the participant prefers. Interaction 1 is for assessment and quit date planning, Interaction 2 occurs prior to the quit date and can be a group session, Interaction 3 occurs shortly following the quit date, and Interactions 4 and 5 are for relapse prevention if the smoker has quit or probl
• Drug Nicotine patch
  On the target quit day (week 6), participants will be provided 8 weeks of nicotine replacement therapy (24-hour transdermal nicotine patches \[TNP\]).

Primary outcome measures

• 7-day point prevalence abstinence (PPA) at 6-month follow-up [Time frame: Protocol week 30, which is 24 weeks (6 months) after the quit attempt (set at week 6)]

Secondary outcome measures (2)

• 7-day point prevalence abstinence (PPA) at 12-month follow-up [Time frame: Protocol week 54, which is 48 weeks (12 months) after the quit attempt (set at week 6)]
• 7-day point prevalence abstinence (PPA) at 9-month follow-up [Time frame: Protocol week 42, which is 36 weeks (9 months) after the quit attempt (set at week 6)]

Eligibility criteria

Inclusion criteria

• Adult (age ≥ 18);
• High Anxiety Sensitivity (≥5 on the Short Scale Anxiety Sensitivity Index \[SSASI\]);
• Daily smoker, ≥5 cigarettes (including e-cigarettes, little cigars/cigarillos) for ≥1 year;
• Motivated to quit smoking as evidenced by a score of ≥5 on a 0-10 Likert scale;
• Body mass index < 40;
• Medical clearance to participate.
• Located near a participating YMCA site (within 50 miles)

Exclusion criteria

• Regular exercise defined as engaging in vigorous-intensity exercise for at least 75 minutes per week for the last 3 months
• Receiving current intervention for smoking cessation.
• Outstanding debt to the YMCA
• Listed as a sex offender on the National Sex Offender Registry

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 1 center

• University of Texas at Austin — Austin

Identifiers

NCT: NCT06053567 · 2016120049 · R01CA273221

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗