About this trial

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?

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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;

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

Aerobic Exercise
Behavioral
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.
Counseling
Behavioral
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.
Nicotine patch
Drug
On the target quit day (week 6), participants will be provided 8 weeks of nicotine replacement therapy (24-hour transdermal nicotine patches \[TNP\]).

Treatment groups

360 Participants

are divided into 2 treatment groups

Group A: High-Intensity Aerobic ExerciseExperimental treatment 3 interventions

Group B: Low-Intensity Aerobic ExerciseActive comparator 3 interventions

Trial outcomes

Primary outcomes

1

7-day point prevalence abstinence (PPA) at 6-month follow-up

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.

Time frame

Protocol week 30, which is 24 weeks (6 months) after the quit attempt (set at week 6)

Secondary outcomes

1

7-day point prevalence abstinence (PPA) at 12-month follow-up

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.

Time frame

Protocol week 54, which is 48 weeks (12 months) after the quit attempt (set at week 6)

2

7-day point prevalence abstinence (PPA) at 9-month follow-up

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.

Time frame

Protocol week 42, which is 36 weeks (9 months) after the quit attempt (set at week 6)

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

About this trial

Eligibility criteria

Qualifiers

Disqualifiers

Trial design

Treatments tested in this trial

Treatment groups

Trial outcomes

Primary outcomes

Secondary outcomes

Other outcomes

Sponsors and contacts