Summary Information to Help you Decide Whether to Join this Study

Study Title	Tart Cherry Juice Impact on Anxiety & Depression
Study Author	Reviewer User, Zeeshan LDninjas, Gaurav Participant, Matthew Amsden, Jasper Schmidt
Principal Investigator	Matthew Amsden, CEO Efforia. Dr. Viral Patel Sub-Investigator for Adverse Events
Sponsor	This study is made possible by your payment to join.
Cost of Products, Services & Information to Participant	$20
Included Products & Services	Withings Sleep Mat, Oura Ring
Outcome Measures	General Anxiety Disorder (GAD-7), PHQ-8
Contact	help@efforia.com

Introduction & Summary

Welcome! We invite you to join this research study on the Efforia platform, made possible by your support. Efforia is a registered Delaware B Corporation, which means we consider the public good in addition to traditional business factors.

This study aims to understand the impact of tart cherry juice on anxiety and depression. Your participation is voluntary and you can leave the study at any time without penalty. Even if you leave the study, you may continue to use the products and services you’ve purchased. If you prefer not to use them, partial or full refunds may be available by contacting Efforia at help@efforia.com.

Before you decide to join, we recommend seeking answers to any unresolved questions by contacting Efforia, conducting your own research, and speaking with any health professional who knows your unique circumstances.

Efforia is a citizen science platform where studies are effectively sponsored by you, the participants. Unlike traditional research studies, you pay for all the supplies, services, information, and tools needed for participation in one transaction. This makes studies possible that might not be otherwise.

Although you could buy these products and services separately for a similar cost, Efforia bundles them into one purchase for convenience. Efforia organizes these items and provides instructions to create a comprehensive, data-driven research experience. This setup allows you to track and understand the impact on your own life via detailed outcome reports, making informed personal health decisions easier. It also advances broader research findings, benefiting others who might not afford such purchases without guaranteed results.

Efforia is committed to equitable inclusion. If the cost is too high for you, click the large Efforia logo at the top of the screen to explore other protocols. Efforia offers protocols on various topics at different price points, including free options, so you can find one that suits your goals and budget.

Purpose of the Study

This study aims to evaluate the effects of tart cherry juice on symptoms of anxiety and depression. Participants will complete standardized questionnaires like the General Anxiety Disorder (GAD-7) and the Patient Health Questionnaire (PHQ-8) to track their mental health over time. The study is designed to provide both individual insights and broader scientific data on the potential benefits of tart cherry juice. Products included in this study are the Withings Sleep Mat and the Oura Ring, which help monitor sleep and overall health metrics.

What You Will Do as Part of this Study

While participating in this research study, you will need to:

• Be willing and able to follow the study directions and procedures
• Tell Efforia about any side effects or problems by communicating with help@efforia.com or online chat
• Ask questions as you think of them via help@efforia.com or online chat
• Inform Efforia if you change your mind about staying in the study. You may leave the study at any time by communicating with help@efforia.com or chat

The Risks, Discomforts & Benefits of Being in this Study

There are some unique risks, discomforts, and potential benefits of being in this study that you should understand.

Consider your Own Risk-Benefit Comfort Level

We encourage you to thoroughly weigh the risks and benefits of participation. We are placing more responsibility on you to make the right choice than in a traditionally sponsored trial. Since this is an experimental exercise, there may be possible unknown side effects that the authors are unaware of. Participants have the responsibility to consult with their healthcare providers and conduct further research at sources they find reputable before enrolling in the study.

Personal and Overall Findings

Efforia will provide you with both personal outcomes as well as overall findings. These findings will be made available at various data collection points in your experience in the study or as they are discovered by Efforia. The results and findings may impact your interest and willingness to be involved in the study. Remember that participation is voluntary and you may exit at any time with an email to help@efforia.com.

Possible Benefits of Participation

Potential benefits of participating in this study include gaining a better understanding of your symptoms and how tart cherry juice might affect them. You will also contribute to broader scientific knowledge that could help others. There is a possibility that there will be no measurable benefit to you, other than seeing reports that the intervention or treatment had no measurable impact.

Possible Serious Adverse Events & Side Effects

In the Case of an Adverse Event

If you experience any adverse events while using the Withings Sleep Mat or Oura Ring, it is crucial to seek immediate medical care by calling 911, especially if symptoms are severe or life-threatening. Once any acute situations have been addressed, please contact Efforia to report the incident. This information is vital for ongoing safety monitoring and product improvement.

Introduction and Summary of Known Risks

The following is a summary of known risks. However, research is limited, and there may be risks not covered by this document, risks that are currently unknown or unforeseen. Please consider these risks carefully, do your own research, and talk to a professional who knows you well and has expertise in this area, like your personal physician.

Common risks associated with devices like the Withings Sleep Mat and Oura Ring include skin reactions, sleep disturbances, and data privacy concerns. Most side effects noted in studies and consumer reports are mild and resolve on discontinuation of use. Maximum dosages or usage limits are generally dictated by user comfort and device-specific operations rather than pharmacological limitations.

Serious Adverse Events (SAEs)

Theoretical side effects	Relative incidence	Recovery
Skin irritations (allergic reactions, rashes)	Low	Resolves after discontinuation
Data privacy breaches (unintended sharing of sensitive information)	Very low	Varies
Cognitive impairment (due to sleep disturbances)	Medium	Resolves after discontinuation
Frustration and irritation	Medium	Varies

Efforia’s Limitations in Providing Direct Medical Support

It is important to note that Efforia does not provide direct medical support or emergency services. Users should maintain regular contact with healthcare providers and rely on traditional medical infrastructure for emergency situations.

Long-Term Dependence Issues

No long-term dependence has been directly associated with the use of Withings Sleep Mat or Oura Ring. However, psychological dependence on device data for daily decision-making regarding health may occur.

Legality for Use by Various Institutions

The use of devices like Withings Sleep Mat and Oura Ring is generally permissible under guidelines from institutions such as the World Anti-Doping Association, National Collegiate Athletic Association, and in most corporate workplace environments. However, individual policies may vary, and users should verify the acceptability of these devices within their specific organizational or regulatory context.

Inappropriate Participants Inclusion/Exclusion

Under the Efforia minimal risk protocol, within which this study is reviewed for safety and human subjects ethics, all individuals over the age of consent are eligible, however, it is the responsibility of participants to determine if their unique circumstances make participation inappropriate.

Based on the risks informed consent, intervention, and outcome measures, here is a table identifying the kinds of people who should avoid being part of this trial:

Category of Individual	Contraindications	Reason
Individuals with known skin allergies	Use of Withings Sleep Mat or Oura Ring	Risks of skin irritations, allergic reactions, and rashes
Individuals concerned about data privacy	Use of Withings Sleep Mat or Oura Ring	Potential for data privacy breaches and unintended sharing of sensitive information
Individuals with existing cognitive impairments	Use of Withings Sleep Mat or Oura Ring	Risks of sleep disturbances leading to further cognitive impairment
Individuals prone to anxiety or frustration	Use of Withings Sleep Mat or Oura Ring	Risks of frustration and irritation varying among users
Individuals without access to emergency medical services	Use of Withings Sleep Mat or Oura Ring	Efforia does not provide direct medical support; reliance on traditional medical infrastructure is essential
Individuals with psychological dependence on health data	Use of Withings Sleep Mat or Oura Ring	Risk of developing psychological dependence on device data for daily health decision-making
Individuals subject to restrictive institutional policies	Use of Withings Sleep Mat or Oura Ring	Varying policies regarding the use of such devices in certain organizations or regulatory contexts
Individuals with specific dietary restrictions	Consumption of tart cherry juice	Potential for adverse reactions based on unique dietary needs or restrictions
Individuals with known allergies to cherries or related fruits	Consumption of tart cherry juice	Risks of allergic reactions to cherries or related fruits
Individuals with contraindicated medical conditions	Consumption of tart cherry juice	The therapeutic properties of tart cherry juice may interact negatively with certain medical conditions
Individuals taking certain medications	Consumption of tart cherry juice	Potential for interactions between tart cherry juice and specific medications

Participants should carefully consider these factors and consult with their personal physician to determine if their unique circumstances make participation appropriate.

Privacy & Security Risks

We are doing everything we can think of to keep your data private and confidential. However, there is no such thing as no risk. Potential participants should review the Efforia general privacy policy, which is available here: https://efforia.com/privacy-policy/

There may be very certain limits to the rights of your privacy:

• We may reach out to local help if we have reason to believe you may be a harm to yourself and/or others.
• Regulators, like the FDA or similar agency, or Institutional Review boards may review records that have your identifying information.

What to do if you have a study related injury

If you have a study-related injury, seek local medical care first if necessary. Efforia cannot provide emergency medical care or diagnosis. However, it is important to contact Efforia in case you experience any problems, have any side effects, or have any study-related injury after you’ve received any necessary treatment. This helps us make sure others are aware of potential risks.

Study related injury care and compensation

Efforia is not able to offer financial compensation nor to absorb the costs of medical treatment should you be injured as a result of participating in this research. Efforia makes no commitment to provide free medical care or payment for any unfavorable outcomes resulting from participation in this research.

In the case of medical emergency

In the case of medical emergency please dial 911 immediately. Do not attempt to contact Efforia until after the emergency has passed. Access local in person medical assistance immediately. If at any time you feel like you may be a danger to yourself or others, please dial 988 for the National Suicide Prevention hotline. Help is available.

Alternatives to Participating in the Study

Since this study is for research only, the only other choice would be not to be in the study. If this study does not seem quite right, or is too expensive for your specific purposes, Efforia is dedicated to making other studies available. You may click on the Efforia logo in the upper portion of the page and find a different study that may be more appropriate.

Your Rights as a Participant

Efforia upholds the same high ethical standards in research as seen in pharmaceutical and academic studies, despite only hosting and not sponsoring or conducting these studies. Your participation in this study is completely voluntary, and you are free to withdraw at any time without any adverse consequences. You are not giving up any rights by signing this document.

Efforia may remove you from the study if you have violated Efforia’s overall terms and conditions, privacy policy, or have a conflict of interest. Efforia may also remove you from the study in the interest of safety based on individual or community findings.

Privacy and Confidentiality

You have a right to privacy and confidentiality in this research effort. Your personal information is protected through robust measures ensuring anonymity or confidentiality. All data processing is designed to safeguard personal data against unauthorized access and misuse.

Right to Your Own Results

Participants have the right to a complete explanation of the research once their involvement concludes, particularly if the study involves any form of deception like placebos or controls.

The Right to Leave a Study without Penalty at Any time

If you decide to withdraw from the study, you can do so at any time by visiting your Profile page, selecting “Your Protocols,” and clicking “Leave.” Upon leaving, you will be refunded for any consumable products that have not yet been shipped. For non-consumable products, a full refund will be issued upon their return in accordance with our return policy. This ensures that you can participate in the study with the assurance that your financial contributions are handled fairly and with respect for your consumer rights.

Conflict of Interest Statement

As part of our commitment to ethical conduct and transparency in our citizen science clinical trial, it is essential to disclose the unique structure of our study. This clinical trial is hosted by Efforia, but it is uniquely sponsored by you, the participants. Efforia serves solely as the platform provider and does not sponsor or influence the study outcomes.

Efforia takes a transaction fee on all the products and services included in this protocol. Otherwise, we have no financial interest or conflicts of interest. To further reduce conflicts of interest, we will remind you once if you do not complete enrollment in this study. We will not remarket to you, nor otherwise push you to join the study.

How we Reduce Conflicts of Interest

You also have a role in reducing conflicts of interest. It is crucial that participants do not have any financial relationship with the intervention methods or measurement providers used in the trial, nor should they be employees, investors, stakeholders, or protocol authors associated with these entities. Participation under such conflicts of interest could significantly compromise the study’s integrity and the validity of its results.

Consequences of Conflict of Interest Non-Compliance

Should you fail to disclose such a conflict of interest or if a breach of this policy is discovered, you will be subject to immediate suspension from this platform and payments may not be refunded.

By joining this trial, you affirm that you understand the above conflict of interest restrictions and agree to comply fully with them. Your participation is valued, and your adherence to these guidelines ensures the validity and reliability of our collective scientific efforts.

Data Protections

Your data will be collected, used, and protected in compliance with data protection laws. You own your data, and it will be housed on Efforia indefinitely until you tell us to delete it by emailing help@efforia.com.

What you can do to improve your privacy and security

As part of participating in this study, you will receive notifications via email, SMS, or push notification when new study tasks like questionnaires and reminders are ready for you. You can adjust your communication preferences in the Efforia application at any time. If you do not want to receive notifications from this study, do not press the Accept button. You can decide not to join this study and will not receive notifications. To ensure others don’t see these alerts, make sure your phone or desktop computer and your email accounts are protected by a password, pin, or other form of “access control.” You should also avoid sharing your accounts with others or sharing your account passwords. As this study is hosted in Efforia, it is governed by a set of privacy and confidentiality standards that put you, as a participant, in control. You can learn more about Your Privacy and Security rights on Efforia here: https://efforia.com/privacy-policy/.

Who will have access to your data?

Efforia will have access to your data, and there may be partners who also have access to your data (like labs and connected health devices).

What will we do with your data?

We will use the data to show you your own personal results and pool your results with other participants to provide general outcomes. We will not use your information connected with your name or anything that connects the data with you without your permission.

Authorization to Use and Disclose Protected Health Information

If you decide to take part in this study, the study doctor and study staff may use and share protected health information (PHI) about you to conduct the study. Protected health information may come from your medical or research records. Protected health information may include the following:

• Name
• Location
• Dates
• Phone Numbers
• Email Addresses
• Internet protocol (IP) address numbers

The study staff may share protected health information about you with the following authorized users to ensure the quality of the study conduct and study data:

• Efforia
• The Office of Human Research Protections (OHRP);
• Univo Institutional Review Board; and
• University of Portsmouth Ethics Review Board
• Other regulatory agencies

Once your protected health information has been shared with authorized users, it may no longer be protected by federal privacy laws and could possibly be used or disclosed in ways other than what is listed in this section.

Your permission to use and share protected health information about you will end after you have completed the study and any after study related activities unless you revoke your permission sooner.

You can revoke your permission to use and share protected health information about you at any time by contacting the study doctor listed on the first page of this document. If you revoke your permission, you will not be able to stay in this study. No new protected health information will be collected after your request has been received. The protected health information about you that has already been collected may still be used and given to others as described in this section.

If you decide not to sign and date this document, you will not be able to take part in the study. However, you may continue to use and consume anything you’ve purchased to be part of the study outside the study.

California Experiential Research Subject’s Bill of Rights

Participants in California have additional rights under the California Experiential Research Subject’s Bill of Rights. Please review the Efforia privacy policy for more information: https://efforia.com/privacy-policy/.

Who to Contact for Questions or Concerns

If you have questions, concerns, or complaints about this study or to report a study-related injury, contact:

HELP@EFFORIA.COM
OR CLICK THE CHAT BUTTON ON YOUR SCREEN
We will immediately respond with an automated message giving you a sense of how long a more meaningful response will take based on the volume of other requests.

(646) 679-2479. If no one is available, please leave a message.
We will typically respond to telephone messages in three to five business days.

If you are unable to reach