Dear Participant: Thank you for being interested in participating in the Tracking Restriction, Affect and Cognitions (TRAC) Study. TRAC is an online and telephone-based treatment research study that aims to better understand eating disorders and co-occurring suicidality. The study is being conducted by Cheri Levinson, Ph.D. at the University of Louisville and April Smith, Ph.D. at Auburn University. It is sponsored by the National Institute of Health (NIH) and will be conducted remotely.

We are recruiting individuals with Anorexia Nervosa or Atypical Anorexia who have experienced thoughts of death, not wanting to be alive, suicidal ideation, or a suicide attempt.

To be eligible, participants must be within age of 18-65, reside within the United States, and be medically stable. Other eligibility criteria may apply.

Prescreening: The prescreening questionnaire involves answering questions about your contact information, demographics, various emotions, thoughts, and behaviors on a confidential online survey. This online screening survey will take approximately 3-5 minutes. Responses to the screening questionnaire will be used to determine eligibility for continuing participation in the screening interview and main phase of the study (see below for more information about participation in the main study phase).

Screening interview: If you are eligible, to further evaluate your experiences and eligibility, you will then be scheduled for the remote assessment, which involves answering questions about your experiences. The intake interview will take approximately 1.5 – 2 hours to complete and will be recorded for training purposes, if consented.

Baseline Questionnaire: If you are eligible and interested in continuing, the study will involve completing an online questionnaire to gather further information about your demographics, various emotions, thoughts, and behaviors.

Main Study: If desire to continue participation into the main study, the study will involve completing online questionnaires via your mobile phone (5x a day) and wearing a sensor wrist band daily for 21 days. The sensor band will be provided to you. You will also be asked to wear the wristband overnight and complete a sleep diary for 7 consecutive days during this 21 days period in addition to wearing it during the daytime.

Follow ups: One month, six months, and one year after the study is complete, the study will invite you to complete virtual follow-up questionnaires and assessment.

Compensation: You will receive up to a $350 gift card for your participation.

For completing the baseline questionnaires and interview you will be compensated $60. You will also be compensated based on the number of mobile application surveys completed and the days you wore the sensor band for up to $140. For completing the follow-ups at one, six, and twelve months after the study, you will receive an additional $50 for each follow-up survey.

More details about study activities will be provided upon enrollment in the main study phase for eligible participants.

There are potential risks for your participation in this phase of this study. You may experience boredom, distress (negative emotional reactions), and/or inconvenience when answering questions that may be sensitive. The information collected may not benefit you directly. The information learned in this study may be helpful to others. The information you provide will contribute to research examining important topics in child emotional development. Your completed survey will be stored in password protected files in our locked research laboratory accessible only by trained study staff.

Individuals from the University of Louisville’s Department of Psychological and Brain Sciences, the Institutional Review Board (IRB), the Human Subjects Protection Program Office (HSPPO), and other regulatory agencies may inspect these records. In all other respects, however, the data will be held in confidence to the extent permitted by law. Should the data be published, your identity will not be disclosed.

The Department of Health and Human Services (HHS) has issued a Certificate of Confidentiality to further protect your privacy. With this Certificate, the investigator may not disclose research information that may identify you in any Federal, State, or local civil, criminal, administrative, legislative, or other proceedings, unless you have consented for this use. Research information protected by this Certificate cannot be disclosed to anyone else who is not connected with the research unless:

1) there is a law that requires disclosure (such as to report child abuse or communicable diseases but not for legal proceedings);

2) you have consented to the disclosure, including for your medical treatment; or

3) the research information is used for other scientific research, as allowed by federal regulations protecting research participants.

You should understand that a Confidentiality Certificate does not prevent you or a member of your family from voluntarily releasing information about yourself or your involvement in this research. If you want your research information released to an insurer, medical care provider, or any other person not connected with the research, you must provide consent to allow the researchers to release it. This means that you and your family must also actively protect your own privacy. Finally, you should understand that the investigator is not prevented from taking steps, including reporting to authorities, to prevent serious harm to yourself or others.

Taking part in this study is voluntary. By answering screening survey questions, you agree to take part in the prescreening of this research study. You do not have to answer any questions that make you uncomfortable. You may choose not to take part at all. If you decide to be in this study, you may stop taking part at any time. If you decide not to be in this study or if you stop taking part at any time, you will not be penalized.

If you have any questions about your rights as a research subject, you may call the University of Louisville Human Subjects Protection Program Office at (502) 852-5188. You can discuss any questions about your rights as a research subject, in private, with a member of the University of Louisville Institutional Review Board (IRB). The IRB is an independent committee made up of people from the University community, staff of the institutions, as well as people from the community not connected with these institutions. The IRB has reviewed this research study.

If you have any questions, concerns, or complaints about the research study, please contact Dr. Cheri Levinson, Ph.D. (cheri.levinson@louisville.edu, (502) 852-7710) at the University of Louisville and Dr. April Smith (ars0152@auburn.edu, (334) 844-7011) at Auburn University.

If you have concerns or complaints about the research or research staff and you do not wish to give your name, you may call 1-877-852-1167. This is a 24-hour hot line answered by people who do not work at the University of Louisville.

Sincerely, Dr. Cheri Levinson and Dr. April Smith

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