About the Study

This study is being conducted by Sarah Linke, M.S., a graduate student in the San Diego State University (SDSU) / University of California San Diego (UCSD) Joint Doctoral Program in Clinical Psychology. Ms. Linke is conducting the study under the supervision of Thomas Rutledge, Ph.D., and Mark Myers, Ph.D., clinical psychologists in the Department of Psychiatry at UCSD and at the Veterans Affairs Medical Center (VAMC). This study was made possible by funding from the National Institute on Drug Abuse (NIDA) division of the National Institutes of Health (NIH).

Approximately 120 individuals will participate over the next two years. The study will primarily take place in your own environment (e.g., at home, work) and via the Internet, but will also include three in-person assessments at the Clinical Research Center (CRC) building at the University of California San Diego (UCSD) in La Jolla. The main part of the study that requires your daily participation from home and two in-person visits to the CRC will last for twelve weeks. The follow-up part of the study will occur six months after the end of the initial twelve weeks. Your third and final visit to the CRC will be at the end of that six month follow-up period.

Study Description

1. You will decide upon a target quit date with the principal investigator (PI), Sarah Linke. This date should be within 1-2 weeks from the date of your enrollment in the study.

2. Two to three days prior to your quit date, you will report to the CRC at UCSD in La Jolla for a baseline assessment that will last approximately 1.5 hours. At that visit you will (a) complete a set of questionnaires about a variety of social, behavioral, and mental health topics; and (b) complete an exercise testing protocol (detailed below). You will also be randomly assigned to one of two experimental groups: Internet only or Internet and exercise intervention.

3. For the next twelve (12) weeks you will complete the intervention portion of the study. All participants should attempt to quit smoking during that time. To help you in your quit attempt, you will be asked to complete the web-based intervention, which includes:

a. self-paced, weekly readings about smoking cessation and accompanying questions to assess your understanding of the information (approximately 5-10 minutes per weekday or 25-45 total minutes per week);

b. daily self-reported cigarette use (i.e., how many cigarettes smoked, even if 0), completed on the study’s secure website (approximately one minute per day);

If you are assigned to the Internet + exercise group you will be asked to complete additional procedures throughout the 12-week intervention phase of the study, including the following:

a. daily exercise, completed in multiple (3-6), short bouts (5-15 minutes each) of time (for a total of 30-90 minutes per day) and tailored to meet each participant’s individual capabilities (specific instructions will be sent weekly);

b. daily self-reports of exercise, cigarette craving levels, and mood, completed on the study’s secure website (approximately 10 minutes per day).

If you are assigned to the Internet only group you will be asked to maintain your baseline level of activity, which should not include regular physical activity/exercise. If you are assigned to the Internet only group and decide to begin exercising regularly during the study, please notify the PI immediately. You will still be eligible to participate in the rest of the study, but the researchers need to be aware of any changes in your physical activity levels.

4. At the end of the twelve intervention weeks and again six months later, you will report again to the CRC at UCSD La Jolla for post-intervention and follow-up assessments that will last approximately 1.5 hours each. At each of those visits you will (a) complete the same set of questionnaires that you completed at the baseline visit; (b) complete the same exercise testing protocol (detailed below); and (c) provide a breath and/or urine sample to verify your self-reported smoking status at that time. You will be given a small monetary award ($25) at the six-month follow-up visit for completing the entire study, regardless of your smoking status.

Potential Risks

Participation in this study may involve some added risks or discomforts. These include:

1. You might feel uncomfortable completing some of the questionnaires that ask about personal and/or emotional subjects. You may elect to refrain from answering any questions that make you feel uncomfortable. While these feelings are usually temporary, if they persist we will consult UCSD mental health treatment services and ensure that you receive appropriate care. If you experience such problems, please contact Dr. Rutledge (licensed clinical psychologist and supervisor of this study) at 858-552-8585, Extension 7273, for assistance.

2. You may experience discomfort and be at an increased risk of adverse health events while undergoing the exercise testing protocol. However, this assessment is sub-maximal and should not pose any serious risk. Nevertheless, a number of precautions will be taken to further minimize this risk, such as ensuring that your physician has cleared you for exercise testing and having a nurse on-site to assist with the testing. Also, if you experience shortness of breath, dizziness, chest pain, or other symptoms of discomfort associated with physical exertion during the supervised exercise testing, you will be requested to stop the activity. If the symptoms worsen, you will be transported by the PI and a nurse to the Urgent Care Clinic at UCSD.

3. If you are randomized to the Internet and exercise condition, you may be at higher risk for certain health events while exercising. Also, you may also experience mild soreness from exercise in the initial week or two. However, these risks will be minimal as long as you follow the exercise instructions, which gradually increase your physical activity. In fact, your health will actually improve in the short- and long-term due to your increased physical activity.

4. You may experience discomfort and withdrawal symptoms as you attempt to quit smoking. To minimize the impact of these symptoms, you will be provided with information through the study website that will give you ideas on alternative ways to cope with your cravings. While these symptoms may be uncomfortable and unpleasant at first, they should subside with time, and they pose no real physical danger to you. In fact, if you can withstand your discomfort and refrain from smoking, your health will be protected and enhanced in the short- and long-term.

If you feel that these or any other problems related to the study are too overwhelming, you always have the option of discontinuing the protocol for any reason. Also, a crisis hotline telephone number will be provided to you at the beginning of the study, with instructions to call if an emergency arises in which you feel compelled to harm yourself or others. In addition, at any time during the protocol if you develop 1) a clinically significant or worsening mood, 2) suicidal ideation, 3) symptoms of hypomania or mania, or 4) any delusional or psychotic thinking, you will be referred for immediate psychiatric treatment.

Potential Benefits

Benefits to you. If you successfully adhere to the study’s protocol (i.e., maintain abstinence from smoking and adhere to the exercise program if applicable), your health may benefit. You may improve your cardiovascular and lung function in the short-term and increase your lifespan in the long-term. Furthermore, you may experience mental health benefits such as improved mood and enhanced self-efficacy from abstaining from smoking and/or increasing your physical activity. Even if you are able to adhere to only one of the two behaviors (i.e., smoking cessation or increased exercise) or if you are only able to reduce your smoking or increase their physical activity below the recommended amount, you may experience benefits. Furthermore, you may also benefit from the knowledge about smoking cessation, relapse prevention, stress management, and exercise that you will gain through the online tutorial created for this study. I cannot guarantee, however, that you will receive any benefits from participating in this study.

Benefits to science and society Smoking and inactivity are the two biggest health threats to Americans, and the proposed study addresses both of these behaviors. The knowledge to be gained from the proposed research focuses on learning whether a novel exercise program that capitalizes on the opportunities to engage in exercise that smokers have, by instructing them to exercise multiple times per day for relatively short durations when they experience cigarette cravings and would usually smoke, increases the likelihood of short-term and sustained smoking cessation or reduction above that of an online smoking cessation program. Also, it explores whether this type of exercise program is acceptable to smokers who are attempting to quit by assessing exercise protocol adherence throughout the study. The study also examines whether this type of exercise program leads to improvements in the five components of physical fitness assessed and/or effectively reduces the amount of weight that is typically gained during smoking cessation attempts. Finally, it explores psychosocial correlates of smoking cessation and exercise induction by assessing variables such as depressive symptoms and positive and negative affect. Answering these questions has broad public health implications, as smoking and inactivity are the leading causes of preventable death among U.S. adults.

Alternatives to Participation

Participation in the study is voluntary. If you choose not to participate or to terminate your enrollment at a later date you are encouraged to seek assistance with your smoking cessation attempt through other avenues offered through medical, research, or community resources.

Confidentiality/Privacy

In order to protect your confidentiality and privacy information will be kept in locked cabinets in a locked office until data entry is complete, and destroyed within six months of data collection.

After signing the informed consent form, you will be assigned an identification number in order to identify you without the use of names or other personal information for the remainder of the study. No identifying information will be entered into the database, and only the researchers will have access to the data. Data will be stored on a protected network to which only researchers and laboratory staff have access.

Federal regulations require that the Institutional Review Board (IRB) periodically review all approved and continuing projects that involve human subjects. To ensure that your rights as a subject are being protected in this study, it is possible that representatives of the Institutional Review Board may come to this research site to inspect study records.

In some cases during the study, your confidentiality may necessarily be broken. These circumstances include: if you are deemed to be imminently suicidal; if you report grave threats of violence or aggression to identifiable persons; or if we obtain evidence that a child or elder in your care is in danger. In such cases, we are legally required to take action to protect you or others. Should we identify information that suggests you are at-risk to yourself, we will direct you to appropriate care at no cost to yourself (e.g., the urgent care clinic or psychiatric inpatient clinic for suicidality) and relay the information to your primary care provider.

Incentives for Participation

If you participate in this study you will receive assistance with your smoking cessation attempt at no cost. The content of the educational tutorial is a modified version of the website created by researchers at the University of California San Francisco (UCSF) for their own research on smoking cessation. Results from the UCSF team’s research studies have shown that their website is an effective smoking cessation aide. Thus, you will be receiving an effective cessation aide at no cost to you. Furthermore, if you are assigned to the exercise group, you will also receive daily exercise prescriptions at no cost. If you follow the exercise instructions, you may have an increased chance of successfully quitting. Smoking cessation programs such as this one are typically quite expensive when not affiliated with research studies.

A monetary incentive ($25) will be offered to you at the follow-up visit six months after you complete the study. This modest monetary award should be enough to cover any expenses you may incur from traveling to and from the CRC at UCSD in La Jolla for all three study visits.

Study-Related Costs

You may incur charges for the following requirements of this study:

1) Charges from obtaining physician clearance required for participation in the study. If this cost is the only barrier to your participation, a basic examination will be provided at no cost to you by a UCSD physician in order to fulfill this necessary requirement.

2) Transportation costs to the CRC at UCSD in La Jolla for the three in-person assessments.

Compensation for Participation

If you are injured as a direct result of participation in this research, the University of California will provide any medical care you need to treat those injuries. The University will not provide any other form of compensation to you if you are injured. You may call the UCSD Human Research Protections Program office at (858) 455-5050 for more information about this, or to inquire about your rights as a research subject, or to report research-related problems.

Voluntary Participation

Participation in this study is voluntary. Your choice of whether or not to participate will not influence your future relations with NIH/NIDA, SDSU, or UCSD. If you decide to participate, you are free to withdraw your consent and to stop your participation at any time without penalty or loss of benefits to which you are allowed.

Contact Information

If you have any questions about this study at any time throughout your participation or afterward, you may contact any of the study personnel at the VAMC San Diego (858) 552-8585, Extension 5979 (Sarah Linke) or 7273 (Thomas Rutledge).

If you have any questions about your rights as a participant in this study, you may contact an Institutional Review Board (IRB) representative in the Division of Research Administration at SDSU (telephone: 619-594-6622; email: irb@mail.sdsu.edu) or UCSD Human Research Protections Program (HRPP) at 858-455-5050.