Participant Information and Consent Form
Anorexia Nervosa: EEG Response to Triggers
Dr. C.L. Birmingham, BSc. MHSc. FRCPC FACP ABIM FAED
Internal Medicine, Epidemiology, Professor of Psychiatry UBC
Vancouver Coastal Health, UBC Hospital
Shelley Sidhu, BSc.
General Biology, Faculty of Science, UBC
- 1. Invitation
You are being invited to take part in this research study because you have been diagnosed with anorexia nervosa (AN).
- 2. Your participation is voluntary
Your participation is voluntary. You have the right to refuse to participate in this study. If you decide to participate, you may still choose to withdraw from the study at any time without any negative consequences to the medical care, education, or other services to which you are entitled or are presently receiving.
You should be aware that there is a difference for both you and your doctor between being a patient and being a research participant. As a patient, all medical procedures and treatments are carried out for your benefit only according to standard accepted practice. As a research participant, you and your doctor also must take into account the requirements for the research study. These may include procedures and treatments that are not part of standard procedures or are not yet proven. This consent form describes the diagnostic and treatment procedures that are being carried out for research purposes. Please review the consent document carefully when deciding whether or not you wish to be a part of the research and sign this consent only if you accept being a research participant.
If you wish to participate in this study, you will be asked to sign this form.
Please take time to read the following information carefully and to discuss it with your family, friends, and doctor before you decide.
- 3. Who is conducting this study?
This study is not receiving funds from an external agency or sponsor.
- 4. Background
Anorexia nervosa (AN) is a complex illness, and it can be hard to find a treatment that works for all patients. In previous brain-imaging studies, it has been shown that patients with anorexia have increased brain activity when they are exposed to a particular stimulus (or trigger) that is related to their eating disorder. These studies are very important because they help researchers understand the role of the brain in anorexia, which in turn could help doctors develop more effective treatments. Unfortunately, the brain imaging methods commonly used in these studies have limited availability, can be very expensive to operate, and can even be harmful to patients.
In this study, we would like to explore the use of an alternative brain-imaging tool, Low Resolution Electromagnetic Tomography Analysis (LORETA), to learn more about how
anorexia affects the brain. LORETA is able to provide two valuable pieces of information about brain activity: 1) where in the brain it is taking place, and 2) how much brain activity is taking place in that area. Unlike other brain-imaging methods, the equipment for LORETA is portable, relatively inexpensive, and poses little or no side effects to patients. LORETA is not yet widely used in eating disorders research, but it has been used to view and assess brain function in other psychological conditions such as depression and certain types of phobia. We hope to determine if LORETA can be similarly applied to study brain function in anorexia.
In this study, we will be using LORETA as a tool to measure brain activity of anorexic patients under certain conditions, not as a treatment method for anorexia. LORETA is not presently used as a treatment method for anorexia. However, we believe that LORETA could one day help us develop more effective, individualized treatments that target the brain abnormalities underlying this serious disease.
- 5. What is the purpose of the study?
In this study, we will use LORETA to measure how the brain activity of AN patients changes in response to two different types of food-related triggers: 1) looking at pictures of food, and 2) imagining a situation related to food or eating. We would like to find out which of these two triggers causes the bigger change in brain activity, which we will take to represent a greater anorexic fear response. We believe that LORETA is the ideal imaging tool for this experimental set-up because it will allow us to track changes in brain activity as they happen after the trigger is presented.
- 6. Who can participate in this study?
You may be able to participate in the test group if:
- You have been diagnosed with anorexia nervosa
- You are aged 17 or older
- 7. Who should not participate in this study?
You will not be eligible to participate in this study if:
- You have been diagnosed with an eating disorder other than anorexia nervosa
- 8. What does the study involve?
Overall design of the study
The study will take approximately 2 hours of your time and consists of two sessions.
The initial session will be used to explain study procedures in detail, answer any questions you may have, and confirm that you meet the criteria for participation. This first session will take 30-45 minutes of your time. Before you leave, we will set up a convenient time for you to come back for the second session.
The second session is the LORETA scan session. Before scanning, we will ask you to provide a verbal or written description of two scenarios, one that makes you feel anxious and one that makes you feel relaxed. Then, we will use the LORETA scan to measure your brain activity at rest and under two conditions: 1) while you are looking at pictures of food and other objects, and 2) while you are imagining the two scenarios that you provided earlier. After each of these conditions, we will ask you to fill out a short questionnaire about how you are feeling. You do not have to answer any questions that make you feel uncomfortable. The total duration of the session will be 60-75 minutes, but the actual LORETA scan itself will take only 25-30 minutes.
At the end of the second session, the PI or a member of the research team will be available if you wish to discuss your experience or have any further questions regarding the study.
If You Decide to Join This Study: Specific Procedures
If you agree to take part in this study, the procedures and visits you can expect will include the following:
- Initial Session
- Location: Room 1813, Detwiller Pavilion, UBC Hospital
- Duration: 30-45 minutes
Before obtaining your consent to participate, we will invite you to come to the testing room, explain the study procedures to you, and answer any questions you may have about participating. If you meet the eligibility criteria and consent to participate, we will ask you to sign this consent form and schedule a convenient time for you to return for the LORETA scan session. We will need to consult your health record to confirm your diagnosis of anorexia nervosa as well as other co-existing conditions, the medications you are currently taking, and your current BMI.
- LORETA Scan Session
- Location: Room 1813, Detwiller Pavilion, UBC Hospital
- Duration: 60-75 minutes
This session will consist of three parts.
During the first part, we will ask you to think of a situation related to food/eating that gives you anxiety. We will give you the option of either recording a short verbal description (15-30 seconds) OR writing a short description (2-3 sentences) of this situation. We will ask you to do the same for a situation that makes you feel relaxed.
During this time, we will also explain the scanning procedures to you and familiarize you with the LORETA scan equipment.
- LORETA Scan
During the LORETA scan, you will be comfortably seated in a padded wooden chair in front of a computer screen. You will wear a headpiece that looks just like a shower-cap with electrodes on it. The electrodes in the cap are used to detect your brain’s electrical activity and are connected to a device that measures the size and location of the activity. The scanning procedure does not hurt.
Once we begin scanning, you do not need to do anything except sit as still as possible and follow the instructions that you hear. The following section is provided to give you an idea of the sequence of events you can expect, but you will be given all necessary instructions again during the scanning.
LORETA SCAN – SUMMARY OF PROCEDURES
- Resting I:
We will begin scanning when you are comfortably seated and relaxed. You will hear instructions to open and close your eyes from time to time.
- Condition I:
You will be asked to look at a series of photographs displayed on the computer monitor in front of you. There will be photos of food and other objects. After all the photos have been displayed, you will be asked to rate the level of stress or anxiety you feel on a scale of 0-10 (0= completely relaxed; 10= extremely stressed and anxious).
- Resting II:
This will be a rest period, during which you will stay comfortably seated and relaxed as we continue scanning. You will hear instructions to open and close your eyes.
- Condition II:
You will hear descriptions of the situations you provided earlier either played back to you or read to you by the experimenter. You will be asked to imagine yourself in each situation for a specific length of time. After each situation has been repeated twice, you will be asked to rate the level of stress or anxiety you feel on a scale of 0-10, as in Condition I.
- Resting III:
This will be the final rest period, during which you will stay comfortably seated and relaxed.
After the LORETA scan, you will be given an opportunity to discuss your experience and share questions or concerns with the PI or a member of the research team.
- 9. What are my responsibilities?
- You will need to sit relatively still for 25-30 minutes during the LORETA scan
- You will need to wear a plastic cap on your head during the LORETA scan
- You will need to look at pictures of food and other objects for 5 minutes
- You will be asked to describe a situation that makes you feel anxious
- You will be asked to describe a situation that makes you feel relaxed
10. What are the possible harms and discomforts?
We recognize that any material related to food or eating may cause psychological discomfort in patients with anorexia. You may feel uncomfortable when you are asked to describe a food/eating-related situation that makes you feel anxious. In order to minimize this discomfort, we will ask you to choose between describing the situation aloud or in writing – whichever is easiest for you. You will also have the opportunity to speak with your doctor or a counsellor after the scanning session if you need additional support.
We do not expect the LORETA scan to cause significant harm or discomfort to participants. There is a slight chance that you will experience a mild headache after scanning.
11. What are the potential benefits of participating?
No one knows whether or not you will benefit from this study. There may or may not be direct benefits to you from taking part in this study.
We hope that the information learned from this study can be used in the future to benefit other people with anorexia nervosa.
12. What if new information becomes available that may affect my decision to participate?
You will be advised of any new information that becomes available that may affect your willingness to remain in this study.
13. What happens if I decide to withdraw my consent to participate?
You may withdraw from the study at any time without giving reasons.
If you choose to enter the study and then decide to withdraw at a later time, all data collected about you up to the point of your withdrawal from the study will be retained for analysis. You will not be penalized in any way for your withdrawal.
14. Can I be asked to leave the study?
It is extremely unlikely that you would be asked to leave the study. However, if you become uncontrollably anxious and the Investigator judges that continuing in the study would be harmful to your health, he may withdraw you from the study and will arrange for your care to continue. If you are asked to leave the study, the reasons for this will be explained to you and you will have the opportunity to ask questions about this decision.
15. How will my participation in this study be kept confidential?
Your confidentiality will be respected. However, research records and health or other source records identifying you may be inspected in the presence of the Investigator or his designate by representatives of Vancouver Coastal Health and the UBC Clinical Research Ethics Board for the purpose of monitoring the research. No information or records that disclose your identity will be published without your consent, nor will any information or records that disclose your identity by removed or released without your consent unless required by law.
You will be assigned a unique study number as a participant in this study. This number will not include any personal information that could identify you (e.g., it will not include your Personal Health Number, SIN, or your initials, etc.). Only this number will be used on any research-related information collected about you during the course of this study, so that your identity will be kept confidential. Information that contains your identity will remain only with the Principal Investigator and/or designate. The list that matches your name to the unique study number that is used on your research-related information will not be removed or released without your consent unless required by law.
Your rights to privacy are legally protected by federal and provincial laws that require safeguards to ensure that your privacy is respected. You also have the legal right of access to the information about you that has been provided to the sponsor and, if need be, an opportunity to correct any errors in this information. Further details about these laws are available on request to your study doctor.
16. What happens if something goes wrong?
By signing this form, you do not give up any of your legal rights and you do not release the study doctor, participating institutions, or anyone else from their legal and professional duties. If you become ill or physically injured as a result of participation in this study, medical treatment will be provided at no additional cost to you. The costs of your medical treatment will be paid by your provincial medical plan.
17. Who do I contact if I have questions about the study during my participation?
If you have any questions or desire further information about this study before or during participation, or if you experience any adverse effects, you can contact either:
- the Principal Investigator, Dr. Birmingham, at 778-837-9002
- the Co-Investigator, Shelley Sidhu, at 604-561-5503
18. Who do I contact if I have questions or concerns about my rights as a participant?
If you have any concerns or complaints about your rights as a research participant and/or your experiences while participating in this study, contact the Research Participant Complaint Line in the University of British Columbia Office of Research Ethics by e-mail at RSIL@ors.ubc.ca or by phone at 604-822-8598 (Toll Free: 1-877-822-8598).
19. After the study is finished
After the study is finished, the results may be published in a research journal or presented at a meeting that is open to the public. If you would like to be contacted about how to access these results when/if they become available, please check the box below:
p I give permission for members of the research team to contact me when the results of this study become available to the public.
In the future, we may conduct other studies using LORETA scan in anorexia. Please check the appropriate box below to indicate whether or not you would like to be contacted as a participant in future studies.
p YES, please contact me with information about participating in future studies.
p NO, please do not contact me with information about participating in future studies.
Participant Consent Form
Anorexia Nervosa: EEG Response to Triggers
My signature on this consent form means:
- I have read and understood the information in this consent form.
- I have had enough time to think about the information provided.
- I have had the opportunity to ask questions and have had satisfactory responses to my questions.
- I understand that all of the information collected will be kept confidential and that the results will only be used for scientific purposes.
- I understand that my participation in this study is voluntary.
- I understand that I am completely free at any time to refuse to participate or to withdraw from this study at any time, and that this will not change the quality of care that I receive.
- I understand that I am not waiving any of my legal rights as a result of signing this consent form.
- I will receive a signed copy of this consent form for my own records.
I consent to participate in this study.
Participant’s Signature Printed name Date
Signature of Person Printed name/Study Role Date