INFORMED CONSENT DOCUMENT AGREEMENT TO BE IN A RESEARCH STUDY

Challenge/Study Title	Anxiety Reduction via Reveri App & Golf
Challenge Coach (The Person in Charge of This Research Study)	Illia Pantsyr, Patrick Killen, Matthew Amsden, Reviewer User
Sponsor	This study is made possible by your payment to join.
Challenge Cost	$250
Included Products & Services	Reveri Hypnosis App, Arccos Golf Smart Sensors
Outcome Measures	General Anxiety Disorder (GAD-7), Hamilton Anxiety Rating Scale (HAM-A) Survey
Contact	help@efforia.com

Introduction to the Study

Welcome to this unique research study available exclusively on the Efforia platform. This study, "Anxiety Reduction via Reveri App & Golf," is not only an opportunity to participate in groundbreaking research but also a chance for you to make a direct contribution to the science behind anxiety management. We thank you for considering participation and your financial contribution that makes this research possible.

Efforia is a citizen science platform. This study, like many on Efforia, is effectively sponsored by participants. This approach is unique because it requires a small payment. This makes the study possible when traditional research funding is limited or unavailable. Your payment covers all the supplies, services, information, and tools you need to participate.

While you could buy these products and services separately on the open market for a similar total cost, Efforia bundles them into one purchase for ease. Efforia also organizes these items and provides instructions to help create a thorough, data-driven research experience - something that would be difficult to achieve independently. This setup not only allows you to track and understand the impact on your own life, making it easier to make informed personal health decisions, but it also helps advance broader research findings. These findings can benefit others who might not be able to afford self-experimentation purchases without a strong guarantee of results.

What's Involved

Overview of Participant Responsibilities in the Anxiety Reduction via Reveri App & Golf Challenge Study

Duration: The study spans a period of 90 days.

Schedule and Timeline:

Initial Setup:
- Upon commencement, integrate your Google Calendar, MS Outlook, and ToDo list with the study schedule to ensure no session is missed.
- Set communication preferences and prioritize emails from Efforia to receive all updates promptly.
Daily Activities:
- Use of the Reveri Hypnosis App: You are required to engage with the Reveri app on a daily basis. This involves following the specific mindfulness and hypnosis protocols provided within the app.
- Golf Sessions: Regular golfing sessions must be integrated into your routine, the frequency of which should be aligned with the guidelines provided at the start of the study.
Assessments:
- Baseline Measurements: At the start of the study, complete the General Anxiety Disorder (GAD-7) and Hamilton Anxiety Rating Scale (HAM-A) assessments.
- Follow-up Measurements: At the conclusion of the 90-day period, repeat the GAD-7 and HAM-A assessments to measure changes and impacts of the intervention.

Importance of Adhering to the Timeline:

Participant Safety: Strict adherence to the prescribed schedule ensures that the interventions are received as intended, mitigating any risks associated with improper use of the hypnosis app or physical activity.
Optimal Outcomes: Following the schedule allows you to maximize the benefits of both mindfulness practices and physical activity, potentially leading to significant improvements in your mental wellness.
Scientific Validity: Your compliance with the timeline contributes directly to the reliability and validity of the study results. Accurate and timely data is crucial for assessing the effectiveness of the combined interventions and for future recommendations.

Critical Points:

Ensure all sessions, both app-based and physical (golf), are attended to as per the schedule.
Prompt completion of all baseline and follow-up assessments is crucial.
Maintain open communication lines with the study coordinators, and report any issues or deviations in the schedule immediately.

By meticulously following these guidelines, you not only enhance your own potential for improved mental health but also contribute significantly to broader scientific research aimed at developing effective anxiety reduction strategies.

The Purpose of This Study

The primary aim of this study is to explore the effectiveness of combining mindfulness practices through the Reveri Hypnosis App with physical activity via golf, utilizing Arccos Golf Smart Sensors, to reduce anxiety levels in participants. The study will measure the outcomes using two specific tools:

General Anxiety Disorder (GAD-7): A seven-item scale that measures general anxiety symptoms.
Hamilton Anxiety Rating Scale (HAM-A): A psychological questionnaire used for rating the severity of a patient's anxiety, based on 14 parameters.

The Reveri Hypnosis App provides guided mindfulness and hypnosis sessions designed to reduce stress and improve mental health. The Arccos Golf Smart Sensors are advanced gadgets that attach to your golf clubs to track your swings, providing feedback that helps improve your golf game while encouraging physical activity, which is known to reduce anxiety.

This study aims to contribute to scientific knowledge by providing data on how these combined interventions can help reduce anxiety, potentially offering a new avenue for therapy. The findings could have significant implications for improving mental health strategies and could benefit individuals who struggle with anxiety disorders.

Your Rights as a Participant

Ethical Considerations

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.

Privacy and Confidentiality

Your personal information is protected through robust measures ensuring anonymity or confidentiality. All data processing by AI systems is designed to safeguard personal data against unauthorized access and misuse.

Respect and Personal Choice

All participants are treated with dignity and respect, acknowledging their autonomy and decision-making capabilities, particularly to join studies that might not otherwise be possible under a traditional funding model.

Maximized benefit and minimized risk

The design and execution of this study aim to maximize benefits and minimize harm to participants. This includes continuous monitoring for any adverse effects during participation.

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.

Feedback Mechanism

A email customer support process for providing immediate feedback or filing complaints regarding the study or its methodology and a promise that we will address and respond within 2 business days.

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.

Risks and Benefits

Interventional New Drug Application Report: Reveri Hypnosis App and Arccos Golf Smart Sensors

Introduction and Summary of Known Risks:

The Reveri Hypnosis App and Arccos Golf Smart Sensors are part of a combined treatment protocol aimed at reducing anxiety through the use of digital mindfulness practices and physical activity, specifically golf. While the primary intention of this treatment is to leverage the calming effects of mindfulness and exercise, it is crucial to understand the potential risks involved.

"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."

Serious Adverse Events (SAEs):

Mental Health Discomfort: Excessive reliance on the app for anxiety management without professional guidance might exacerbate or mask underlying mental health issues. These effects are generally anecdotal and require further research for conclusive evidence.
Physical Injury from Golf: Using golf sensors and engaging in golf activities can lead to sports-related injuries, which may result in hospitalization or long-term disability if not addressed promptly.

Minor Risks and Side Effects:

Cognitive Impairment, Intoxication, or Loss of Control: While not common, overuse or dependence on the hypnotic state induced by the app could theoretically lead to reduced alertness in daily activities, although confirmed instances are lacking.
Fatigue and Headaches: Prolonged use of digital screens and concentration during hypnosis sessions or golf may lead to fatigue and headaches. These symptoms typically subside after discontinuing the activity.
Mood Changes and Sleep Disturbances: Changes in mood and sleep patterns may occur, particularly if the app significantly alters one’s routine. These risks are primarily supported by anecdotal evidence.

Instructions for Adverse Events:

In case of experiencing severe discomfort or physical injury, users are advised to discontinue the treatment immediately and seek medical attention. Efforia does not provide direct medical support; therefore, contacting a healthcare provider is essential.

Long-term Dependence Issues:

While there is no concrete evidence suggesting long-term dependence on the Reveri Hypnosis App, the possibility exists that users might become habitually reliant on the app for stress management or sleep assistance. Continued monitoring and moderation of use are recommended.

Legality and Institutional Acceptance:

World Anti-Doping Association (WADA) and National Collegiate Athletic Association (NCAA): There are no known restrictions against the use of mindfulness apps or golf sensors in these organizations. However, athletes are advised to check the latest regulations.
Corporate Workplace: Usage in the workplace should comply with company policies regarding mobile app use during working hours and the appropriateness of engaging in physical activities such as golf.

Conclusion:

This intervention, combining the Reveri Hypnosis App and Arccos Golf Smart Sensors, presents a novel approach to managing anxiety through mindfulness and physical activity. While the risks associated with this treatment are minimal and often speculative, they warrant consideration and periodic review. Participants are encouraged to maintain open communication with healthcare providers to mitigate any potential adverse effects effectively.

Frustration and irritation: Some users may experience discomfort, frustration and irritation with the technology that Efforia users to conduct studies, with the thoughts and feelings by answering probing questions and/or waiting for test results, and with a lack of progress towards reaching health goals.

No Benefit: A key risk to all studies is that there is no benefit, and that participants receive no benefit from the proposed intervention or treatment, despite the financial payment the participant has made.

Acknowledgment of Risk and Responsibility

Participating in citizen science trials, such as this one, involves unique responsibilities and some risks that you should understand. Efforia does not endorse or sponsor this trial; it is merely hosted on the Efforia platform. Below, we explain what this means for you as a participant.

Consider your Own Risk-Benefit Comfort Level

"It is possible that not all risks and benefits are currently known. Participants have the responsibility to consult with their healthcare providers and conduct further research before enrolling in the study."

Responsible for any Additional Costs & Medical Care

"In the case of an adverse event, it is the participant's sole responsibility to seek and finance their medical treatment. Efforia, as a non-sponsor, is absolved from any claims and can not reimburse any expenses incurred."

Reporting Adverse Events

It is crucial for participants to report any adverse events to Efforia. This allows the sharing of such information with other participants, promoting overall safety and awareness within the community.

The Limits of Efforia Medical Oversight

If the study involves any lab tests or items requiring a prescription, asynchronous medical oversight will be available to assist in mitigating risks. However, participants should understand that this oversight does not replace the need for personal responsibility or local medical care.

Legal Acknowledgment

"This document serves as a legally binding acknowledgment of the risks associated with participating in a study and explicitly limits Efforia's liability. Efforia will not be held liable for any claims except in cases of gross negligence or willful misconduct. This acknowledgment underscores the importance of personal diligence and responsibility throughout the study participation."

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 or conflicts of interest. We are not paid by the sponsor of this study. 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, or otherwise push you to join the study.

How we Reduce 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 a participant fail to disclose such a conflict of interest or if a breach of this policy is discovered, the participant will be subject to immediate suspension from this platform. Depending on the nature of the violation, additional legal proceedings may be initiated as warranted by law to address the breach adequately.

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

Data collected during this study will be used solely for research purposes and protected according to stringent data protection laws. All personal information will be anonymized or encrypted to prevent unauthorized access, ensuring your privacy and the confidentiality of your data.

California Experiential Research Subject’s Bill of Rights

Participants in California are entitled to certain protections under the California Experiential Research Subject's Bill of Rights. For a detailed understanding of your rights, please click here.

Additional questions and closing

If you have questions, please contact help@efforia.com. It is up to you to do additional research and talk to your physician before joining a study. Your informed decision is crucial for a positive and safe research experience.

Authorization and Consent for Diagnostic Testing

I voluntarily consent and authorize CWI Physician Partners P.C., a California professional corporation; CWI Physician Partners P.C., a Hawaii professional corporation; CWI Physician Partners P.C., a Georgia professional corporation; CWI Physician Partners P.C., a Kansas professional corporation; CWI Physician Partners P.C., an Oregon professional corporation; CWI Physician Partners P.C., a Nevada professional corporation, CWI Physician Partners P.C., a Rhode Island professional corporation; CWI Physician Partners P.C., an Oklahoma professional corporation, as applicable ("CWI") to review the collection, testing, and analysis for the purposes of a diagnostic screening test. I understand that there are risks and benefits associated with undergoing a diagnostic screening testing and there may be a potential for false positive or false negative test results. I assume complete and full responsibility to take appropriate action with regards to my test results. Should I have questions or concerns regarding my results, or a worsening of my condition, I shall promptly seek advice and treatment from an appropriate medical provider. I further acknowledge the following:
1. I am the individual who will provide the sample for the Test(s) that I am requesting or I am the parent or legal guardian of a minor who is providing the sample for testing.
2. I am at least eighteen (18) years of age or I am the parent or legal guardian of a minor who is providing the sample for testing.
3. I have read and understand the information provided about the Test(s) that I have been provided on the website where I requested the Test.
4. The information I have provided in connection with my request to CWI is correct to the best of my knowledge. I will not hold CWI or its employees or agents responsible for any errors or omissions that I may have made in providing such information.
5. My health information and results may be shared with CWI employees and agents for the purpose of ordering, processing, and reporting my results.
6. Medical Services provided by CWI are purely for diagnostic assistance purposes and do not create a physician-patient relationship, and do not constitute medical care or diagnosis or treatment of any condition, disease, or illness.
7. I authorize CWI to contact me via text message to communicate with me regarding my test.

Patient Rights and Privacy Practices
1. Notice of Privacy Practices and Patient Rights: CWI Notice of Privacy Practices describes how it may use and disclose your protected health information for other purposes that are permitted or required by law. To review a copy of CWI Notice of Privacy Practices, go to http://www.CynergyWellness.com.
2. Disclosure to Government Authorities: I acknowledge and agree that my test results and associated information may be disclosed to appropriate county, state, federal, or other governmental and regulatory entities as may be permitted by law.

Release
1. To the fullest extent permitted by law, I hereby release, discharge and hold harmless, CWI, including, without limitation, any its respective officers, directors, employees, representatives and agents from any and all claims, liability, and damages, of whatever kind or nature, arising out of or in connection with any act or omission relating to my diagnostic test or the disclosure of my test results.
2. By selecting the ACKNOWLEDGEMENT during the registration process for diagnostic testing, I acknowledge and agree that I have read, understand, and agreed to the statements contained within this form. I have read the contents of this form in its entirety and voluntarily consent to proceed with these procedures.

What You Need to Know to Participate