Efficacy and Implementation of Exercise-based Smoking Cessation Treatment for Adults With High Anxiety Sensitivity.
Overview
- Phase
- Phase 3
- Intervention
- Aerobic Exercise
- Conditions
- Nicotine Dependence
- Sponsor
- Jasper A. Smits
- Enrollment
- 360
- Locations
- 1
- Primary Endpoint
- 7-day point prevalence abstinence (PPA) at 6-month follow-up
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
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.
Investigators
Jasper A. Smits
Principal Investigator
University of Texas at Austin
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
Arms & Interventions
High-Intensity Aerobic Exercise
Participants assigned to this arm will be instructed to complete 75 minutes per week of aerobic training at 60-85% of the their heart rate reserve.
Intervention: Aerobic Exercise
High-Intensity Aerobic Exercise
Participants assigned to this arm will be instructed to complete 75 minutes per week of aerobic training at 60-85% of the their heart rate reserve.
Intervention: Counseling
High-Intensity Aerobic Exercise
Participants assigned to this arm will be instructed to complete 75 minutes per week of aerobic training at 60-85% of the their heart rate reserve.
Intervention: Nicotine patch
Low-Intensity Aerobic Exercise
Participants assigned to this arm will be instructed to complete 75 minutes per week of aerobic training at 20-40% of the their heart rate reserve.
Intervention: Aerobic Exercise
Low-Intensity Aerobic Exercise
Participants assigned to this arm will be instructed to complete 75 minutes per week of aerobic training at 20-40% of the their heart rate reserve.
Intervention: Counseling
Low-Intensity Aerobic Exercise
Participants assigned to this arm will be instructed to complete 75 minutes per week of aerobic training at 20-40% of the their heart rate reserve.
Intervention: Nicotine patch
Outcomes
Primary Outcomes
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)
Self-report of no smoking (not even a puff) during the previous 7 days, verified by expired carbon monoxide (CO; ≤5ppm), saliva cotinine (\<30 ng/mL), or significant other, and not invalidated by any of these verification measures. Failure to provide any of these 3 verification measures will result in PPA being considered missing.
Secondary Outcomes
- 7-day point prevalence abstinence (PPA) at 12-month follow-up(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(Protocol week 42, which is 36 weeks (9 months) after the quit attempt (set at week 6))