Study Invitation - Meditation Retreat Group

H-2007-0249 Phone Script Version 2, 2007 November 16 Study Invitation Phone Script

[Screener] Hello, my name is ______. I am an investigator with the Laboratory for Affective Neuroscience in Madison, Wisconsin. We are conducting a study on the impact of meditation on basic pain regulation functions, and on the brain mechanisms involved. We will use this information to try to understand how pain regulation processes are flexible skills that can be trained. Do you have a few minutes to discuss possibly being a part of the study we are running this year?

[Potential Participant] “No, I do not want to be in the study.”

[Screener] Thank you for your consideration. Good bye.

NOTE TO SCREENER: Please destroy any and all personally identifying information regarding people who will not be a part of the study.

[Potential Participant] “No, I don’t have time to talk now”

[Screener] Is there a better time for me to call to discuss this?

[Potential Participant] “Yes, a better time to call would be ______”

[Screener] Thank you, I will try to reach you then. Good bye.

[Potential Participant] “Yes, I have a few minutes”

Wonderful. Before I tell you about the study, I would like to ask you several questions to see if you would qualify to be a participant. This information will be kept confidential, and if you end up not participating for any reason, we will destroy any information that could identify you. If you feel uncomfortable answering one of these questions, you don’t have to give an answer. Some of the questions concern alcohol and drug abuse. Would you like to continue?

______What is your age in years? [not within 25-60=Exclude]

Yes No ______Do you currently have a problem with alcohol or non-prescription drugs?

[Screener: Do not record answer to this question. Instead simply make a decision to exclude if the answer is Yes, note in tally form the reason for the exclusion, and then destroy all personally identifying information related to this participant]

______Are you currently taking any prescribed psychotropic medications? [Y=Exclude] (These include medications for anxiety, depression, or other psychological problems)

______Have you previously been trained in meditation?

of 12 H-2007-0249 Phone Script Version 2, 2007 November 16 [If yes] What was the class called and when did it happen? ______[Y=Judgment]

______Do you currently meditate on a regular basis? [Y=Judgment]

______Have you meditated daily for at least the last 2 months? [Y=Exclude]

______In the last year, have you meditated at least weekly for two or more months in a row? [Y=Judgment]

______Have you had daily practice with other mind-body techniques? What techniques? [Screener: Start with open-ended question. But if participant needs examples, give them. Also, after the open-ended response, please ask about the examples as well.] ______

______Daily yoga practice [Y=Exclude; previous exposure ok]

______Daily tai-chi [Y=Exclude]

______Other: ______[Y=Judgment]

______Do you have any chronic pain or sensitivity conditions, such as fibromyalgia? [Y=Exclude]

______Are you currently taking any pain medications, including NSAIDS such as Advil or Aleve, or prescription painkillers such as Vicodin or Ultram? [Y=Exclude]

of 12 H-2007-0249 Phone Script Version 2, 2007 November 16 MRI Screening Form ______\ Sex: Female Male

Age: ______[18-65 ok]

DOB: _____/_____/_____

Weight: ______

Height: ____”____’

[Obesity can be calculated from height and weight]

Hat Size: ______

Ethnicity: ______

Yes No ______Do you have corrected vision?

______Have you ever had an MRI scan? When? ______Why? ______

______Have you ever had surgery or a similar invasive procedure? When? ______Type? ______

______Have you ever had heart surgery? When? ______Type? ______Do you have a Pacemaker? [Y= Exclude] ______Do you have an implanted cardiac defibrillator? [Y= Exclude] ______Do you have an artificial heart valve? [Y= Exclude] ______Do you have cardiac pace wires? [Y= Exclude]

______Have you ever had head or brain surgery? When? ______Type? ______

______Have you ever had eye surgery? ______Do you have lens implants? [Prior to 1983 = Exclude; 1984 or later = ok]

______Do you wear dentures? [If YES] Can you take them out? [Y=ok; N=Judgment] [Note: Judgment means we must check with PI or MR Technician]

______Have you ever had ear surgery? [Tubes ok] ______Do you have a cochlear implant? [Y=Exclude] ______Do you wear a hearing aid? [If YES] Can you take it out [Y=ok; N=Judgment]

______Have you ever had back surgery? When? ______Type? ______Page 3 of 12 H-2007-0249 Phone Script Version 2, 2007 November 16

______Do you have any implanted devices of any type? ______Breast/Penile? [N=ok; Y=Judgment] ______Electrodes? [N=ok; Y=Judgment] ______Pumps (e.g., drug infusion device)? [N=ok; Y=Judgment] ______Bone or socket? [N=ok; Y=Judgment. Titanium ok but need Dr. note] ______Neurostimulators/Biostimulator? [N=ok; Y=Judgment] Yes No

______Do you have any dental or orthodontic implants (fillings are O.K.)? [Metal bars in mouth = PI Judgment] Type? ______

______Do you have any type of prosthesis? [Y=ok if can take it off] Type? ______

______Do you have any type of orthopedic implant (e.g., pins, rods, screws, nails)? [Y= ok with Dr. note] Type? ______

______Do you have any permanent cosmetics (e.g., eyeliner)? [If yes] What year did you get this done? ______[Ok after 1975, else Exclude]

______Do you have any tattoos on your upper body? [If yes] What year did you get this done? ______[Ok after 1975, else Exclude] Where/Extent? ______

______Do you have any body piercing(s)? [If yes] Are they plastic? ______[Y=ok] [If no] Can you take the piercing(s) out? [Y=ok, N=Exclude]

Where? ______

______Do you have a history of any metal in your body?

______Have you every worked as an occupational metal grinder? [Y = red flag for next few questions. Mostly we wantto know whether people have the potential for having metal in their eyes] Description: ______

______Have you ever worked with metal as a hobby? Description: ______

______Did you routinely wear safety glasses? [Y=ok, N=Exclude]

______Have you ever sought medical attention for metal in your eyes? [Y=Judgment: requires orbit x-ray]

______Have you ever had metal fragments removed from your eyes? [Y=Judgment: requires orbit x-ray]

______Have you ever been struck by a gun shot, B.B. or shrapnel? [IF yes] Did it stick? [N=ok; Y=Judgment]

______Do you have any physical disabilities? Type? ______

______Do you have any involuntary motor disorders? [Point is: can they stay still for 90 mins in scanner] Type? ______

______Have you ever experienced claustrophobia? [Y=Exclude] When? ______

______Do you have any back problems that would prevent you from lying still for up to 2 hours? [Y=Exclude]

of 12 H-2007-0249 Phone Script Version 2, 2007 November 16 Female Subjects

______Are you or is there a chance you are pregnant? [Y=Exclude]

______Do you have an intrauterine device (IUD)? [Y=need Dr. note]

**ANY QUESTIONABLE CONDITIONS MUST BE APPROVED BY THE MR TECHNICIANS Ron Fisher or Michael Anderle 262-9230

of 12 H-2007-0249 Phone Script Version 2, 2007 November 16 [Screener: Based on phone call to this point, can this person understand & speak English? [N=Exclude]

[Screener: IF participant DOES NOT MEET STUDY CRITERIA (i.e., 1 or more answers require exclusion)]

I am sorry but based on our exclusion criteria, you do not qualify for the study. We will destroy any information we currently have on you so you can be assured of confidentiality. Thank you very much for your time. Good bye.

NOTE TO SCREENER: Please document the reason(s) this person does not qualify for the study. Do NOT do this by tying it to them as a specific person. It is merely part of a tally so we can determine whether we need to change study criteria if recruitment of participants is too low. Please destroy any and all information about participant.

[Screener: IF 1 or more answers require JUDGMENT, they MAY not meet study criteria: Discussion with investigators is needed]

There is some question about whether you qualify for the study or not. Would you mind if I discussed this with one of the other investigators and re-contacted you by phone or letter at a later time?

[If OK] What would be a good day and time? ______

Let me also take down some information so we can contact you in the future.

Name______

Email Address______

Phone Number ______

Home Address ______

Thank you, we will contact you within the next two weeks Good bye.

[If not OK] I am sorry but based on our exclusion criteria, you do not qualify for the study. We will destroy any information we currently have on you so you can be assured of confidentiality. Thank you very much for you time. Good bye.

[Screener: IF participant MEETS STUDY CRITERIA]

I would now like to read a short description of the study. Please feel free to interrupt me to ask questions.

The University of Wisconsin, Laboratory for Affective Neuroscience, is conducting a research study examining the impact on the brain of meditation. This study will involve two visits to the lab. In the first visit we will explain to you the tasks involved in the study, and familiarize you with the equipment and procedures. We will also administer a mildly painful thermal stimulus to your hand or wrist to calibrate your pain threshold. In the second visit you will have your brain scanned by functional magnetic resonance imaging. In the scanner you will be asked to do two standard meditation practices while experiencing safe and controlled amounts of pain. Moderate heat sensations will be administered on your palm or wrist while you focus attention on a visual external object, and maintain a state of unfocused but alert open awareness.

Participation in this study is voluntary.

of 12 H-2007-0249 Phone Script Version 2, 2007 November 16 The data collected in this study will not have your name or any personal information on it. Instead you will be given a participant identification number (PIN). All data obtained from you will be linked to that number. This number will be linked to your name on a data sheet that will be kept under lock and key.

There will be no cost associated with any part of this study. You will be paid $75 for your participation. If you choose to withdraw from this study after the session in the Simulator Room you will be paid $25. We need to make sure you are well motivated to perform these meditation tasks. It is expected that the strength of your effort to meditate will be correlated with activation in brain regions participating in attention. Therefore, if after examining your brain data, we see activation in brain regions participating in attention that is high enough to be in the top four of all control participants in this study, we will give you an extra $50 bonus. The bonus will be given after the study is completed and all data are analyzed. If you wish, we will also provide you with a picture of your brain taken during the MRI.

University regulations require anyone receiving payment to hold U.S. citizenship, or an F-1 or J-1 visa. No other visa types may be accepted for payment. Please be sure to inform the study administrators if you do not meet this requirement.

Do you have any questions? [Potential Participant] Yes

[Screener] Answer questions as well as possible

[Potential Participant] No. I do not have questions.

[Screener] If you think you might be interested in participation in the study, we would like to schedule your first visit. Are you interested in participating in this study?

[If no] We are interested in why some people may not want to be in the study. If you are comfortable, we would be interested in why you would prefer not to participate.

______

Wonderful. I am delighted that you are interested. I’d like to do two more things now. First, let me take down some information so we can contact you in the future.

Name______

Email Address______

Phone Number ______

Home Address ______

Best times:

Thank you. Now let’s schedule your first visit.

[Potential Participant chooses a time]

of 12 H-2007-0249 Phone Script Version 2, 2007 November 16

Wonderful. So, we’ll plan on seeing you on ______at ______a.m./p.m. at the Waisman Center at 1500 Highland Avenue in room # ______on the ______floor. Do you mind if we call or email you the night before your scheduled meeting to remind you?

[Potential Participant] “Yes.”

Okay, we won’t call or email you to remind you. We’ll see you on ______at ______a.m./p.m.

[Potential Participant] “No.”

Okay, we’ll send you a reminder email or give you a reminder phone call on ______. If you have any questions between now and the information session, please call (608) 235-3294. Thank you.

[Screener: If it becomes apparent that the potential subject is either not eligible or not interested, please keep a tally of the reason they are not eligible and destroy the information on that individual (contact information and any preliminary screening data).]