The Serenity research Study is a voluntary research study exploring different approaches to stress management to see if they can help lower blood pressure. The study involves weekly stress management classes, offered at no cost to you, for 8 weeks. There will also be visits to the study office for up to 12 months after you complete the stress management classes. At the study visits, we will measure your blood pressure, take other measures of heart function, and ask you to complete questionnaires on the computer.
In order to determine if you are eligible to participate in the study, we will need to conduct a brief questionnaire with you, which involves answering questions about your health. If you are eligible after completing the brief questionnaire, we will ask you to come to our office for up to 2 screening visits where we measure your blood pressure. These are for screening purposes only, to ensure that you qualify for the study, and they each take about 45 minutes to an hour. Please note that if your blood pressure is high enough where we would recommend that you seek medical treatment (readings in the hypertensive range or higher), or we uncover other health risks during screening that warrant medical attention, you will be informed of this at your visit. In rare circumstances of urgent health risks, we may recommend emergency care.
At your first screening visit we will also have you complete a brief (10-minute) questionnaire about your demographic information (ethnicity, education level, etc.). If you are eligible after the 2nd screening visit, you will go through our intake process and be officially enrolled in the study.
To protect confidentiality, identifying information will be accessible only to specific study staff in both a locked filing cabinet and a password-protected computer file and will be destroyed after the study is completed and all applicable participant payments have been made. Data collected from you throughout the screening process will be identified by code number only and not associated with your personally identifying information.
Would you like to complete the brief eligibility questionnaire online now?
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Would you like to be contacted by study staff to discuss the study and complete the brief eligibility questionnaire over the phone?
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Thank you for your time. If you would like more information on the study, please visit www.SerenityStudy.org
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The stress management program is an 8-week group-based course that will teach you stress management techniques and allow you to practice them with the help of a skilled instructor in the class and you will also be provided with resources to practice at home.
The classes will be held in University City on a weeknight around 6:00PM. Each class session lasts about 2.5 hours. There will be 1 class per week for 8 weeks, as well as one weekend class/wellness retreat from 9am - 4pm on a Saturday towards the end of the 8-week program.
The exact date/time scheduling for the classes is not yet determined. Scheduling depends on room availability and the amount of people eligible to participate.
If you are eligible to participate in the study, but cannot attend the first set of classes, we can always hold on to your information and enroll you in the next set of classes that become available.
Are you willing to participate in the 8-week stress management program?
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Are you able to attend study visits at the University of Pennsylvania, located at 3535 Market St., where your blood pressure will be measured and you will be asked to complete questionnaires and other tasks on the computer?
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Is your blood pressure is in the prehypertensive range (between 120/80 and 139/89)?
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Do you have regular access to a computer and feel comfortable completing study tasks on that computer?
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Are you currently taking any medications for high blood pressure?
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List the name of each medication you are taking for high blood pressure.
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Has your irregular heartbeat ever required treatment (i.e. surgery or medication)?
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Have you been diagnosed with a heart muscle or valve abnormality (i.e. valvular disease, hypertrophic or restrictive cardiomyopathy)
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Have you ever required treatment for this heart muscle or valve abnormality?
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Have you been diagnosed with high blood pressure/ hypertension? (Blood pressure greater than 139/89)
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Have you been diagnosed with diabetes?
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Have you been diagnosed with kidney disease? (this does NOT include kidney stones)
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Has your thyroid disease been managed with medication at a steady dose for the past 6 months?
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Have you dealt with alcohol or substance abuse in the past 12 months?
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Have you been diagnosed with dementia?
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Have you been diagnosed with bipolar disorder, schizophrenia, psychosis, or a personality disorder?
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Do you drink more than 21 alcoholic beverages per week (an average of more than 3 drinks per day for a week or more)?
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Have you smoked cigarettes or used tobacco at all in the past 6 months?
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Have you practiced meditation or yoga (in class or at home) in the past 12 months?
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About how many hours have you spent practicing yoga or meditation in a formal setting (e.g. in a class with an instructor) in the past 12 months?
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About how many hours have you spent practicing yoga or meditation in an informal setting? (at home, self-guided, etc.) in the past 12 months?
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Please provide any additional notes or things you think might be relevant to participating in the study.
Feel free to also list questions for study staff to answer.