YMCA Exercise Intervention for Smoking Cessation Study
| Status: | Recruiting |
|---|---|
| Conditions: | Smoking Cessation, Tobacco Consumers |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 10/13/2018 |
| Start Date: | April 12, 2017 |
| End Date: | December 2019 |
| Contact: | Zane Freeman, B.A |
| Email: | zfreeman@utexas.edu |
| Phone: | 512-471-7199 |
Cigarette smoking is the leading cause of death and disability in the United States. Although
smoking has declined since 1964, it is still very common among some groups of people. One
such group is persons with emotional symptoms and disorders. There has been little success in
developing treatments for smoking cessation for smokers with affective disturbances.
Recent work suggests that being sensitive to, and less tolerant of, stress is associated with
many problems in daily life. People with high 'stress sensitivity' tend to use avoidant
strategies to cope with their stress, like smoking. Also, people with high levels of stress
sensitivity report stronger beliefs that smoking will reduce negative feelings. They also
report having a harder time quitting and in fact, are less successful at doing so. This
information suggests that stress sensitivity is important to target during smoking cessation
treatment for smokers with affective vulnerabilities.
This clinical trial will evaluate a treatment that integrates exercise to reduce stress
sensitivity among high stress sensitive smokers. It builds directly from our recent work and
we now seek to adapt it to a more a more accessible and sustainable application. Results will
provide important information on the benefit of an integrated intervention that could be used
in the community for smokers at great risk for relapse and who do not benefit from existing
alternative treatments. This study is the first to test an intervention for stress sensitive
smokers and has the potential to help at-risk individuals experience quitting success and,
ultimately, reduce the burden of tobacco-related cancers in Texas.
smoking has declined since 1964, it is still very common among some groups of people. One
such group is persons with emotional symptoms and disorders. There has been little success in
developing treatments for smoking cessation for smokers with affective disturbances.
Recent work suggests that being sensitive to, and less tolerant of, stress is associated with
many problems in daily life. People with high 'stress sensitivity' tend to use avoidant
strategies to cope with their stress, like smoking. Also, people with high levels of stress
sensitivity report stronger beliefs that smoking will reduce negative feelings. They also
report having a harder time quitting and in fact, are less successful at doing so. This
information suggests that stress sensitivity is important to target during smoking cessation
treatment for smokers with affective vulnerabilities.
This clinical trial will evaluate a treatment that integrates exercise to reduce stress
sensitivity among high stress sensitive smokers. It builds directly from our recent work and
we now seek to adapt it to a more a more accessible and sustainable application. Results will
provide important information on the benefit of an integrated intervention that could be used
in the community for smokers at great risk for relapse and who do not benefit from existing
alternative treatments. This study is the first to test an intervention for stress sensitive
smokers and has the potential to help at-risk individuals experience quitting success and,
ultimately, reduce the burden of tobacco-related cancers in Texas.
Experimental Group. Participants will select a YMCA branch and be assigned a personal fitness
instructor who will act as their case manager, overseeing the integrated exercise-based
intervention for smoking cessation. Guided by our pilot data showing efficacy and
tolerability of the exercise dose, the exercise intervention consists of 75 minutes/week of
aerobic training at vigorous-intensity for 15 weeks2. As in the previous study, the aerobic
training component will be completed on a treadmill and target training intensity will be
self-selected at 60% to 80% of age-predicted heart rate reserve (i.e., vigorous intensity) 2.
In order to maximize adherence, the days of the week and training progression schedule will
be individualized for each participant based on initial fitness level, travel, and any other
issues66,67.
The participant and fitness instructor will meet for three sessions during the first week of
exercise training. During the first session, the fitness instructor will describe the program
(i.e., treatment model and aims), set a target quit attempt for week 6, develop an exercise
training schedule, and supervise the first exercise session to ensure the participant is
exercising properly. After two more supervised exercise sessions during the first week, the
pair will meet one day per week during the following 14 weeks of the study. The fitness
instructors will be responsible for monitoring sessions weekly, problem-solving any
difficulties, adjusting the aerobic and/or resistance training regimen as appropriate, and
entering the participants exercise data into the (REDCap) database specifically designed for
the study.
At the beginning of week 3, the fitness instructor will connect the participant with the
quitline (i.e., warm transfer). The Tobacco quitlines are now available in every U.S. state
via a national quitline portal, 1-800-QUIT-NOW, and have become the major vehicle through
which smoking cessation services are delivered in the U.S.73. All participants will receive
the standard telephone counseling package of up to 5 proactive calls from the Texas Tobacco
Quitline (https://www.quitnow.net/texas/); we will use a 'warm transfer' (i.e., call the
quitline in the presence of the smoker and put them on the phone for the intake interview).
Call 1 is an assessment and planning call, Call 2 is a pre-quit date call, Call 3 is a quit
date call, and Calls 4 and 5 are maintenance calls if the smoker has quit or problem solving
calls if they have not quit. Overall, the counseling protocol aims to (1) provide
cognitive-behavioral smoking cessation and relapse prevention tools, tailored to the
individual smoker's characteristics and; (2) provide medication management and advice
regarding nicotine patch use and adherence support, with the goal of completing a full course
of medication - in this case, 8 weeks of transdermal nicotine patch use.
On the target quit day, the fitness instructor will provide the participants with Nicoderm
CQ®, 24-hour transdermal nicotine patches (TNP) as part of the study. We chose to provide the
patch for 8 weeks because longer than 8 weeks does not appear to improve treatment
efficacy10. We chose the TNP because of the extensive empirical literature supporting its
effectiveness and safety, its ease of use, and its relatively benign side effect profile that
have led to its approval as an over-the-counter medication74. Quitline staff provide
instructions on dose and tapering schedule in a fashion consistent with that used in previous
trials with a similar formulation of the patch10.
Control Group. The intervention procedures for this group are identical to the Experimental
Group group except that the target training intensity will be self-selected at 20% to 40% of
age-predicted heart rate reserve (i.e., light intensity).
instructor who will act as their case manager, overseeing the integrated exercise-based
intervention for smoking cessation. Guided by our pilot data showing efficacy and
tolerability of the exercise dose, the exercise intervention consists of 75 minutes/week of
aerobic training at vigorous-intensity for 15 weeks2. As in the previous study, the aerobic
training component will be completed on a treadmill and target training intensity will be
self-selected at 60% to 80% of age-predicted heart rate reserve (i.e., vigorous intensity) 2.
In order to maximize adherence, the days of the week and training progression schedule will
be individualized for each participant based on initial fitness level, travel, and any other
issues66,67.
The participant and fitness instructor will meet for three sessions during the first week of
exercise training. During the first session, the fitness instructor will describe the program
(i.e., treatment model and aims), set a target quit attempt for week 6, develop an exercise
training schedule, and supervise the first exercise session to ensure the participant is
exercising properly. After two more supervised exercise sessions during the first week, the
pair will meet one day per week during the following 14 weeks of the study. The fitness
instructors will be responsible for monitoring sessions weekly, problem-solving any
difficulties, adjusting the aerobic and/or resistance training regimen as appropriate, and
entering the participants exercise data into the (REDCap) database specifically designed for
the study.
At the beginning of week 3, the fitness instructor will connect the participant with the
quitline (i.e., warm transfer). The Tobacco quitlines are now available in every U.S. state
via a national quitline portal, 1-800-QUIT-NOW, and have become the major vehicle through
which smoking cessation services are delivered in the U.S.73. All participants will receive
the standard telephone counseling package of up to 5 proactive calls from the Texas Tobacco
Quitline (https://www.quitnow.net/texas/); we will use a 'warm transfer' (i.e., call the
quitline in the presence of the smoker and put them on the phone for the intake interview).
Call 1 is an assessment and planning call, Call 2 is a pre-quit date call, Call 3 is a quit
date call, and Calls 4 and 5 are maintenance calls if the smoker has quit or problem solving
calls if they have not quit. Overall, the counseling protocol aims to (1) provide
cognitive-behavioral smoking cessation and relapse prevention tools, tailored to the
individual smoker's characteristics and; (2) provide medication management and advice
regarding nicotine patch use and adherence support, with the goal of completing a full course
of medication - in this case, 8 weeks of transdermal nicotine patch use.
On the target quit day, the fitness instructor will provide the participants with Nicoderm
CQ®, 24-hour transdermal nicotine patches (TNP) as part of the study. We chose to provide the
patch for 8 weeks because longer than 8 weeks does not appear to improve treatment
efficacy10. We chose the TNP because of the extensive empirical literature supporting its
effectiveness and safety, its ease of use, and its relatively benign side effect profile that
have led to its approval as an over-the-counter medication74. Quitline staff provide
instructions on dose and tapering schedule in a fashion consistent with that used in previous
trials with a similar formulation of the patch10.
Control Group. The intervention procedures for this group are identical to the Experimental
Group group except that the target training intensity will be self-selected at 20% to 40% of
age-predicted heart rate reserve (i.e., light intensity).
Inclusion Criteria:
- Male and female participants ages 18-65
- Willing and able to provide informed consent, attend all study visits and comply with
the protocol
- Daily smoker for at least one year
- Currently smoke an average of at least 5 cigarettes per day
- Report a motivation to quit smoking in the next month of at least 5 on a 10-point
scale.
- Anxiety Sensitivity Index-3 score ≥ 23 (cut-off score to identify high AS individuals)
- Sedentary as defined by moderate-intensity exercise less than 3 days/wk for at least
20 minutes each time
- Medical clearance to participate in the protocol
Exclusion Criteria:
- Use of other tobacco products (including e-cigarettes)
- A lifetime history of bipolar disorder, schizophrenia, psychosis, or delusional
disorders; an eating disorder in the past 6 months; organic brain syndrome, mental
retardation or other cognitive dysfunction that could interfere with capacity to
engage in therapy; a history of substance or alcohol abuse or dependence (other than
nicotine) in the last 6 months or otherwise unable to commit to refraining from
alcohol use during the acute period of study participation.
- Patients with significant suicidal ideation as determined by structured interview or
who have enacted suicidal behaviors within 6 months prior to intake will be excluded
from study participation and referred for appropriate clinical intervention.
- Body mass index 40. We selected a BMI of 39.9 as the upper limit in order to screen
out individuals with Class III obesity who might be more prone to musculoskeletal
injuries than individuals with a BMI<40.0).
- Current use of any psychotherapy for smoking cessation not provided by the
researchers.
- Current use of any pharmacotherapy or psychotherapy for smoking cessation not provided
by the researchers during the quit attempt, including Chantix, Zyban, and Nicotine
Replacement Treatment.
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