Preamble

Dear Participant:

You are being invited to participate in the prescreening phase of the PT-Depression Study. This study will use idiographic network modeling to create individual symptom profiles, identifying the most central symptoms that maintain major depressive disorder (MDD). The goal of this project is to collect pilot data to assess the clinical efficacy, acceptability, and feasibility of a personalized, therapist-led and personalized intervention for MDD using idiographic modeling. The study is being conducted by Irina Vanzhula, Ph.D. at the University of Louisville. It is sponsored by the University of Louisville and will be conducted remotely.

Prescreening 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 10-15 minutes. Responses to the screening questionnaire will be used to determine eligibility for continuing participation to the 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 MDD. To be eligible, participants must be within age of 18-65, reside within the United States, be medically stable, and own a smart phone. 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 depression 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 depression symptoms but are unsure if you qualify to continue participation to the main study, these authentication protocols do not apply to you!

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 to 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: 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 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. After completion, participants can participate in 10 therapist-led sessions corresponding to participants' top 3 central symptoms. Sessions will be separated by one week via secure teleconference software, with 1 intake session and 3 sessions per treatment mechanism. You will complete a follow up assessment after session 1.

Main Study Follow ups: After the 10 therapist-led sessions are complete, you will be asked to complete the post-treatment questionnaire. One month after study completion, you will complete a one-month post-assessment questionnaire.

Videoconference Sessions: All screening and therapeutic 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: You can receive $30 for the baseline survey and up to $75 for the completion of the 15-day online assessments. You can receive $30 for the completion of the post-treatment questionnaire and an extra $30 for the completion of the 1 month follow up. Therefore, you can receive a total of up to $165 throughout the course 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 and baseline screening.

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.

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

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. Irina Vanzhula, Ph.D. (irina.vanzhula@louisville.edu, 502-852-9848) 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. Irina Vanzhula

Please indicate whether you would like to proceed by checking one of the options below:

Yes: Having read the information above, I would like to proceed with the screening survey, where:
-I acknowledge that answering screening questions will convey my consent to participate in this study phase, which will include sharing of my information;
-I acknowledge that compensation is based on completion of main study tasks (as described above), which are not part of this prescreening phase.

No: I do not want to proceed with the screening survey.

Yes

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