STEP3: Community-based Smoking Cessation Treatment for Adults With High Stress Sensitivity.
Study Details
Study Description
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?
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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. |
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 problem solving if they have not quit. TTQ also offers a tobacco cessation text messaging program and access to a web portal with a variety of cessation resources.
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]).
|
| Active Comparator: 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. |
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 problem solving if they have not quit. TTQ also offers a tobacco cessation text messaging program and access to a web portal with a variety of cessation resources.
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]).
|
Outcome Measures
Primary Outcome Measures
- 7-day point prevalence abstinence (PPA) at 6-month follow-up [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 Outcome Measures
- 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)]
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.
- 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)]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Adult (age ≥ 18);
-
High Anxiety Sensitivity (≥5 on the Short Scale Anxiety Sensitivity Index [SSASI]);
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Daily smoker, ≥5 cigarettes (including e-cigarettes, little cigars/cigarillos) for ≥1 year;
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Motivated to quit smoking as evidenced by a score of ≥5 on a 0-10 Likert scale;
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Body mass index <40;
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Medical clearance to participate.
Exclusion Criteria:
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Regular exercise defined as engaging in moderate-intensity exercise ≥3 days per week for ≥20 min each time;
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Receiving current intervention for smoking cessation.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Texas at Austin | Austin | Texas | United States | 78712 |
Sponsors and Collaborators
- Jasper A. Smits
- University of Houston
- Oklahoma State University
- National Cancer Institute (NCI)
- YMCA
Investigators
- Principal Investigator: Jasper Smits, PhD, University of Texas at Austin
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2016120049
- R01CA273221