The Rheumatoid Arthritis Multidimensional Project (RAMP)
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What Will I Do During the Study?
Rough Timeline for the GCRC visits
How to Participate / Contact Information
Our Mission
Chronic pain is devastating on many levels: It can cause great personal suffering as well as immense individual and societal financial burden. Current biomedical treatments are often ineffective, and it is now recognized that psychological stress and negative emotion can affect pain (and vice versa) in complex ways. Thus, multidisciplinary approaches to pain management are needed — approaches which merge biological, behavioral, and psychological factors. The purpose of the current project is to investigate the associations between emotion, stress, pain, and inflammation among people with rheumatoid arthritis. We hope that this study will illuminate new ways to improve health and well-being among those with chronic pain, as well as improve understanding of rheumatoid arthritis in general.
Who Can Participate
We are recruiting individuals between the ages of 18-80 who have been diagnosed with rheumatoid arthritis by a physician. During your first in-person visit, we will give you a form to take to your physician, at your convenience, so that he or she can confirm your RA diagnosis.
At this time, those who have taken anti-TNF medications in the past 3 months [e.g., Enbrel (etanercept), Humira (adalimumab), or Remicade (infliximab)] are not eligible. Also not eligible are those taking high doses of corticosteroids, such as > 7.5 mg per day of prednisone. Use of most other medications is OK for this study, although if you participate you will be asked to refrain from taking your "as needed" pain medications from the night before each of your study visits (or 48 hours before study visits in the case of the medication methotrexate). Because of effects on study measures, those who have had major surgery in the last 3 months are not eligible. Further, women who are pregnant or nursing (or who have been pregnant or nursing in the last 3 months), who are taking hormone replacement therapy, and who are taking certain hormonal contraceptives (such as implanted or otherwise continuous contraception) are not eligible at this time.
To apply, please fill out a screening form online click here or request that a paper version of the screening form be mailed to you. The screening process is necessary to determine eligibility related to our health criteria.
What Will I Do During the Study?
First you will be asked to complete a 45-60 minute questionnaire, which can be completed on the internet from any computer; this “Preliminary Questionnaire” will include questions about current mood, perceived stress, pain, and standard psychological traits and thoughts. If you are more comfortable completing this questionnaire on paper, you may request a paper version, which would be mailed to you along with a postage paid return-addressed envelope.
Next, for the main part of the study you will be asked to make a total of 4 visits to the Penn State main campus General Clinical Research Center (GCRC), which is a hospital research unit, across a span of roughly 4 months. For each visit, you will be asked to meet a research assistant at the GCRC at approximately 8:00 am; each visit to the GCRC will take about 5 hours. Before each visit you will be asked to avoid eating or drinking anything other than water after midnight. You will also be asked to avoid taking over-the-counter and certain prescription medications for pain the night before each visit. A breakfast will be provided at the GCRC at approximately 8:30 am. A simple lunch will be provided at the GCRC toward the end of the visit at about 11:45 am.
These four GCRC visits will be scheduled roughly 1 month apart, or over a greater amount of time if necessary. For premenopausal women, we will schedule visits only during the follicular stage of the menstrual cycle (within 3-5 days after the start of a period) to minimize gender differences in hormones.
The GCRC visits are described in detail below. In addition to the GCRC visits, you will be asked to undergo a very brief assessment of your arthritis severity. A physician will determine the number of tender and swollen joints you have and ask you a few questions about your pain and general health. In most cases this assessment will take place during or immediately following your first GCRC visit. If a separate visit is required, it will be scheduled in the morning during the week before or the week after your first GCRC visits and you will be asked to follow the same restrictions on your pain medication use prior to this visit as with the main GCRC visits
At each of the 5 hour GCRC visits, you will have 80 milliliters of blood (which is less than 5½ tablespoons) drawn using a catheter (a small, hollow plastic tube) inserted into a vein in your arm. Before inserting the catheter, a nurse will apply numbing cream to your arm. The catheter enables blood to be drawn at several time points without puncturing your skin with a needle each time; it is only about 1-2 inches long and has the thickness and consistency of a cooked piece of thin spaghetti. A total of 320 milliliters of blood (which is less than 22 tablespoons) will be drawn over the approximately 4 month period of this study. The blood will be used to obtain measures of stress hormones and immune function. Your blood pressure and heart rate will also be measured several times during each visit. In addition, your height and weight measurements will be taken by a nurse, who will also ask you about recent changes to your health and medications.
Throughout each session you will also complete questionnaires of a personal nature that will ask about mood, feelings, health behaviors, health, personality, and demographic characteristics. Further, one time during each session you will be asked to complete a writing and thinking exercise to focus on a particular aspect of your chronic pain and your thoughts and feelings about it; during one of the four GCRCs visit, rather than focusing on your thoughts and feelings you will be asked to write about the types of things that you are able to do and plan given your chronic pain condition. The writing portion of each visit will be approximately 20 minutes and you will have the option of typing or handwriting this material.
Also, at one point during each GCRC visit you will undergo a pain threshold test which is designed to cause mild, transient pain of the sort you might experience during a routine examination to assess arthritis pain severity. We will use a medically-approved device to apply a precise amount of pressure in increasing amounts to 2-3 RA-affected areas (e.g., finger joints) to determine at what amount of pressure you feel pain.
Near the end of each of the GCRC sessions, you will be given a pocket tape recorder and asked to talk out loud for a minute or two about your thoughts about the study or things you may have been thinking about during the study; these tapes will be used to assess your reactions to different parts of the study. These tapes will be kept in a locked file and will be erased once they have been transcribed.
If you develop any health problems over the course of the study, or if you begin taking new medications, you must inform the researchers.
Rough Timeline for the GCRC visits
8:00 Arrive at the GCRC where you will be greeted and taken to a room
8:10 Nurse takes your recent health history, and you provide your medication log
8:20 Nurse applies numbing cream to your arm
8:30 Breakfast in your room
8:50 Nurse inserts catheter into your arm for blood draws
9:00 Questionnaires
9:30 First blood draw, followed by writing exercises and pain threshold test
10:30 Second blood draw and questionnaires
11:00 Third blood draw and questionnaires
11:45 Lunch in your room
12:10 Fourth (final) blood draw and questionnaires
12:30 Final questionnaires and thought listing
12:40 Clinician assessment of RA severity (first-visit only)
In Preparation for the Study
You will be asked not to eat or drink anything other than water after midnight the night before your appointments. You also be asked not to take Ibuprofen (e.g., Motrin, Advil), Acetaminophen (Tylenol), or aspirin from midnight before each of your sessions. You will also be asked not to take Methotrexate (e.g. Rheumatrex, Trexall) within 48 hours of your appointment, and asked not to take other prescription medications for pain (e.g., Ultram/Tramadol) from 10 pm the night before your appointment. You will be asked to make a list of all of the medications you take on a regular basis and to bring that with you to your GCRC appointments.
Confidentiality
Your privacy is very important to us. For all phases of the study, participant responses are completely confidential, to the extent allowed by law. Nobody outside the project staff will have access to your data. To protect your confidentiality, all participants will be assigned an ID number at the start of the study, and each participant’s responses and data throughout the study will be identified by this number. Your confidentiality will be kept to the degree permitted by the technology being used. No guarantees can be made regarding the interception of data sent via the Internet by any third parties. Any research articles that are produced from this study will only report group averages; we will not report how a specific individual responds but rather how people typically respond.
The information you provide in the screening form will also be treated as confidential. If you are eligible to participate and choose to participate, the information you provide in this form will be retained as part of your study data and treated confidentially as described above. If you complete the screening form and are not eligible to participate, or do not participate for any reason, we will retain the information you provide only for the purposes of reporting our general recruiting data (e.g., how many people were interested in the study vs. how many were eligible and general characteristics of both groups); in no way or time will any specific information you provide be reported or linked with your identity (other than for the purposes of contacting you regarding your eligibility or if you indicated you wanted to be contacted about future studies as described below) and your information will not be shared with anyone. On the screening form there will be a place to indicate whether you would be interested in being contacted for any future studies for which it appears you might be eligible; only if you indicate “yes” to that question will your information from the screening form be used by study staff outside of this particular study, and only then by core study staff for the purpose of contacting you.
Benefits
Your participation in this study will help the researchers learn more about the role of stress, emotion, and inflammation in chronic pain. You may feel good about sharing personal information that could help others or lead to research discoveries. You may also learn more about yourself by completing the questionnaires in this study. Information from this study may benefit society by improving awareness of complex issues with rheumatoid arthritis and highlighting potential interventions for chronic pain that could be explored in future research.
How to Participate / Contact Information
If you are interested in participating, please do one of the following: 1) Fill out the online application of the screening application, or 2) call us at 814-867-1682. We would be happy to discuss our research with you, give you more specific information, or mail you an application on paper to be mailed back to us. When you call, please leave a message on the answering machine if no one is available, or 3) E-mail us at stress@psu.edu with your name, phone number, and a time that we can reach you between 8am-5pm during the week; please include the word “RAMP” in the subject heading of your email.
PLEASE NOTE: You must complete the screening application for participation in the study, either online (see above link) or through the mail. Once you complete the application, we will notify you via email or regular mail if you are eligible for the study. If you have junk or spam settings on your email, please set them to recognize our email address, which is stress@psu.edu.