Dear Participant:

You are being invited to participate in the prescreening phase of the PIONEER Study. PIONEER is an online and treatment research study that aims to build a new precision treatment for eating disorders and identify how individual treatment mechanisms relate to public health outcomes, individual disease burden, medical comorbidities, and social determinants of health. The study is being conducted by Cheri Levinson, Ph.D. at the University of Louisville. It is sponsored by the National Institute of Health (NIH) and will be conducted remotely.

Prescreening Phase Procedures: 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 main study (see below for more information about participation in the main study phase).

To be eligible to participate in the main study, participants must have a current diagnosis of any eating disorder except Avoidant/Restrictive Food Intake Disorder (ARFID). To be eligible, participants must be within age of 18-65, reside within the United States, and be medically stable. For prescreening phase participants who are deemed eligible to continue their participation to the main study, other criteria will be assessed to determine eligibility to participate in all main study procedures.

Recently we had an influx of “bad actors” who have no eating disorder symptoms but purposefully and falsely claim that they do for financial gain. Our study team has sophisticated methods to identify such cases. Someone who is intentionally “faking” their symptoms will be deemed ineligible, and payment will be withheld even if some study protocols have been completed. Please note that if you have disordered eating symptoms but are unsure if you qualify to continue participation to the main study, these authentication protocols do not apply to you! The research team is committed to screening people across the eating disorder spectrum and want to ensure that each has a chance to continue participation to the main study. To enable success of this overall study, it is vital that pre-screening phase participants provide accurate information.

Main Study 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 screening interview will take approximately 1.5 – 2 hours to complete and will be recorded for training purposes.To verify your identity, you will be asked to show a photo ID (e.g., US driver’s license, US passport).

Main Study Baseline Questionnaire (Phases I and II): 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 (Phase I): If you choose to continue participation in the main study, the study will involve completing shorter online questionnaires via your mobile phone (5x a day) for 15 days.

Main Study (Phase II): A subset of participants will be selected to participate in Phase II. If you choose to continue to participate, selected participants will complete 1 to 14 virtual sessions of either Transdiagnostic Network Informed Personalized Treatment for Eating Disorders (T-NIPT-ED) or Enhanced Cognitive Behavioral Therapy for Eating Disorders (CBT-E) with a trained clinician for 1 to 14 weeks. You will be provided education about the treatment you will be receiving. During treatment, you will also complete morning and evening phone questionnaires via your mobile phone. You can stop a session and the study at any time. If you are assigned to the T-NIPT-ED condition, you will complete an in-depth assessment of ED diagnoses, medical and psychological comorbidities, disease burden, SDOH and public health outcomes again after treatment. After the final session, you will be asked to complete online questionnaires.

Main Study Follow ups (Phases I and II): Three months after the completion of Phase II, the study will invite you to complete virtual follow-up questionnaires and assessment. If you only participate in Phase I, six months after your completion, the study will invite you to complete virtual follow-up questionnaires and assessment.

Videoconference Sessions (Phase I and Phase II): All screening and therapy sessions will take place over a video conferencing platform, and we will ask you to have the video on for the duration of the session. If you do not enable us to audio and video record the sessions, you will be administratively withdrawn from the study, such that you will be unable to continue participating. Audio and video tapes will be safeguarded just like other research data to protect your privacy.

Main Study Compensation (Phases I and II): After Phase I, you can receive up to $310 for the completion of the diagnostic and outcome assessments if you are not funneled to Phase II. If you are funneled to Phase II, you can receive up to $150 for Phase I and can receive up to an additional $375 for completion of Phase II assessments. Therefore, you can receive a total of up to $525 for participation in both phases of the study. Compensation will be prorated based on the percentage of each survey completed. Compensation will only occur for main study participants. There is no compensation for persons who only participate in the prescreening phase. UofL Institutional Review Boards IRB NUMBER: 23.0529 IRB APPROVAL DATE: 07/09/2025 If at any point during the study, we determine that you intentionally provided inaccurate information about your identity or symptoms (e.g., faking study eligibility criteria for financial gain, enrolling into the study more than once under different names), we will withdraw you from the study and payment will be withheld for any protocols you may have completed.

Individuals who are unable to fully engage with study procedures for any reason may be removed from the study by the study principal investigator. The study investigator may take you out of this study with or without your okay.

During the video screenings and at the beginning of each video therapy session we will be obtaining your height and weight. This information is essential to assess how well the treatment is working and a summary of this data has to be included when the study data is eventually published.

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

There are risks associated with participating in this study’s prescreening phase. Those risks are experiencing boredom or fatigue from answering prescreening questionnaires. There may also be unforeseen risks in participating in this study.

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.

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