Registration

1. Why is this research study being done?

This research is conducted to determine whether psychological intervention delivered online helps young adults to reduce depression symptoms, compared to usual care. To this end, we hope to reduce depression, anxiety, as well as improve ability to cope with distress and develop coping skills. Approximately, 400 young adults will take part in this study in the local State College and Centre county area as well as nationwide thorough social media recruitment.

2. What will happen in this research study?

If you volunteer to participate in this study, you will undergo a screening phase.

1. You will complete a baseline assessment. You will be asked questions about brief mental health history and intervention utilization, to determine if you are eligible to participate in the study. You will be asked for your email address and phone number in order to register interest to participate in this study, and for us to contact you as part of your registration.
2. If it looks like the research study may suit you, you will complete a structured clinical interview which ask about many different aspects of your mental health. Based on your answers, we will know whether this experimental study is helpful for you and if you are eligible to participate.
3. If eligible, you will receive an email from the study email address to provide your consent. You confirm your participation by providing your digital signatures and contact information to the consent. Otherwise, if not eligible you will not be assigned to either condition, and will not participate in the other procedures outlined in the consent form. If you are ineligible for the study and interested in receiving intervention, we will provide various referral options for you.

Once you have provided consent via electronic signature, you will be randomized ­into one of two conditions. When you are randomized you are put into a group by chance (like tossing a coin). You will have a 50% chance of being in into one of two groups receiving access to online psychological online self-help program where you may be given the option to participate in sessions via audio-video communication.

Note that for all parts of the study, you are free to skip any questions that you prefer not to answer. However, all questions must be answered to be considered for eligibility for the trial. If you decide not to participate in this study, contact the study coordinator to be removed from our reminder list.

3. What are the risks and possible discomforts from being in this research study? 

Participants may experience a few foreseeable discomforts. In addition to these, there may be other unknown risks, or risks that we did not anticipate, associated with being in this study.

There is a risk of loss of confidentiality if your information or your identity is obtained by someone other than the investigators, but precautions will be taken to prevent this from happening.  The confidentiality of your electronic data created by you or by the researchers will be maintained to the degree permitted by the technology used. Absolute confidentiality cannot be guaranteed. Some of the questionnaires and interview questions will be about your feelings, such as depression and anxiety. In case you are deemed unsafe or in need of more intensive clinical intervention, our study team will send you the information to contact the mental health resources listed below which may contact you by telephone to assess the appropriate follow-up. The response may involve breaking confidentiality and contacting a licensed mental health professional or a law enforcement officer. If any feelings or thoughts arise that you would like to address with a mental health professional, feel free to call:

• PSU Student: the Penn State Psychological Clinic at 814-865-2191 or Penn State Counseling and Psychological Services (CAPS) at 814-863-0395 to set up an appointment. Participants may also call the CAN Help phone line at 1-800-643-5432 after hours if necessary.
   
• Non-PSU student: alternative resources include the Substance Abuse and Mental Health Services Administration (SAMHSA) intervention directory (findintervention.samhsa.gov) and the SAMHSA 24-hour crisis line (1-800-662-4357).

Participating in this trial does not prevent you from receiving other treatment.

4. What are the possible benefits from being in this research study?

     4a. What are the possible benefits to you?

You consent being gathered here is only for screening. You will not benefit from the screening. Rather it will determine if you are eligible for our study.

     4b. What are the possible benefits to others?

Again, there is no direct benefit to engaging in the study screening.

5. What other options are available instead of being in this research study?

If you do not participate in the screening then you will not be considered for the study.

6. How long will you take part in this research study?

If you agree to take part, you will complete a screening. You will complete questionnaires for 35 minutes, then a clinical interview for 60 minutes, and finally additional study information will be gathered for 10 minutes. it will take you a total of about 1 hour and 35 minutes to complete all tasks.

7. How will your privacy and confidentiality be protected if you decide to take part in this research study?

     7a. What happens to the information collected for the research?

Efforts will be made to limit the use and sharing of your personal research information to people who have a need to review this information. Reasonable efforts will be made to keep the personal information in your research record private. However, absolute confidentiality cannot be guaranteed.

The screening data will be collected by the iTerapi platform and will be stored securely on the platform. Data collected from screening is stored, even if you are not eligible for or decline the study; however, the information kept will be fully de-identified.

• A list that matches your name with your code number will be kept in a locked file or password protected file within a study OneDrive folder at PSU.
• Your research records will be labeled with your study code number and will be kept in a safe area in a separate study OneDrive folder at PSU.

This research is covered by a Certificate of Confidentiality from the National Institutes of Health. This means that the researchers cannot disclose information that identifies you to anyone not connected with the research.  This protection also prevents this information from being used or disclosed for legal proceedings, such as being accessed through a court order. The Certificate of Confidentiality however does not prevent disclosures required by law, such as information about child abuse or neglect and harm to yourself or others.  Also, your information may be disclosed in accordance with any consent you provide, including for your medical treatment or use in other research. Additionally, the Certificate of Confidentiality does not prevent your information from disclosures required to meet FDA requirements.  For additional information ask the principal investigator or a member of the study team or contact the Human Research Protection Program at (814) 865-1775.

In the event of any publication or presentation resulting from the research, no personally identifiable information will be shared.

We will do our best to keep your participation in this research study confidential to the extent permitted by law. However, it is possible that other people may find out about your participation in this research study. For example, the following people/groups may check and copy records about this research:

• The Office for Human Research Protections in the U. S. Department of Health and Human Services
• The Institutional Review Board (a committee that reviews and approves research studies) and Penn State’s Human Research Protection Program.

We would like to contact you by email and phone for the purposes listed below. Some of these text messages and/or emails may contain health information that identifies you.

• Notification of study condition.
• How to access platform/treatment.
• Follow-up on your status and engagement in the study, including sessions, intervention completion, assessments, and interviews.
• Notify you about upcoming sessions.
• If we believe that you are at an increased health risk as a result of your symptoms 

You cannot reply to emails or text messages as these are sent via the encrypted platform used for the study. If you have any questions or need to contact us for an urgent or emergent situation, please contact the research team member identified at the top of this document. Only the research team will have access to your email communications. To avoid sending messages to the wrong email address, the first email we send you will be a message to ensure we have the correct email address. When using any computer you should be careful to protect your username and password.  Make sure you log-out before getting up from the computer.  If you share a home computer with other family members, and do not want them to know you are participating in this study make sure you provide an email address that only you can access. Your employer will have access to any email communications sent or received on any electronic devices used for work or through a work server.

     7b. What will happen to my research information and/or samples after the study is completed?

We may use your research information for future research studies or may share your information with other investigators here or at other institutions for future research without your additional informed consent. Future research may be similar to this study or completely different. Before we use or share your information or samples we will remove any information that shows your identity.

8. What are the costs of taking part in this research study?

     8a. What will you have to pay for if you take part in this research study?

You will not have any costs for being in this research study.

     8b. What happens if you are injured as a result of taking part in this research study?

In the unlikely event you become injured as a result of your participation in this study, medical care is available. It is the policy of this institution to provide neither financial compensation nor free medical treatment for research-related injury. By agreeing to participate in this study, you are not waiving any rights that you have against The Pennsylvania State University for injury resulting from negligence of the University or its investigators

9. Will you be paid or receive credit to take part in this research study?

You will not be paid for completing the screening procedures to determine your eligibility.

10. Who is paying for this research study?

The study is not funded by any outside agency or grant funds.

11. What are your rights if you take part in this research study?

Taking part in this research study is voluntary.

• You do not have to be in this research.
• If you choose to be in this research, you have the right to stop at any time.
• If you decide not to be in this research or if you decide to stop at a later date, there will be no penalty or loss of benefits to which you are entitled.

If any new information arises during the study that may affect your health, welfare, or your decision to continue participating in this research, you will be provided with that information.

If you stop being in the research, already collected data may not be removed from the study database.

12. If you have questions or concerns about this research study, whom should you call?  

Please call the head of the study (principal investigator), Michelle Newman at (814) 863-1148 if you:

• Have questions, complaints, or concerns about the research.
• Believe you may have been harmed by being in the research study.

You may also contact the Office for Research Protections at (814) 865-1775, OR Protections@psu.edu if you:

• Have questions regarding your rights as a person in a research study.
• Have concerns or general questions about the research.
• You may also call this number if you cannot reach the research team or wish to talk to someone else about any concerns related to the research.

Thank you very much for your consideration of this research study. If you do not wish to participate in this study or want to end your participation in the study, do not sign this document. You will not be penalized or lose any benefits for which you otherwise qualify.