Summary Information to Help you Decide Whether to Join this Study

Study Title	Python Yoga for Anxiety Reduction
Study Author	Matthew Amsden
Sponsor	This study is made possible by your payment to join.
Cost of Products, Services & Information to Participant	$0
Included Products & Services
Outcome Measures	General Anxiety Disorder (GAD-7), Depression, Anxiety and Stress Scales (DASS-21) Survey,
Contact	help@efforia.com

Introduction & Summary

Welcome! We invite you to join this research study on the Efforia platform, made possible by your support. This study, titled "Python Yoga for Anxiety Reduction," aims to explore innovative ways to reduce anxiety through a unique combination of yoga and interaction with non-venomous pythons.

Your participation is entirely voluntary, and you may leave the study at any time without penalty. This document provides key information to help you decide whether to join. Please ensure you understand everything, and feel free to ask any questions via help@efforia.com or online chat before proceeding.

Purpose of the Study

The study is conducted to investigate whether engaging in yoga sessions with non-venomous pythons can aid in reducing anxiety. The aim is to explore an unconventional yet potentially effective method for enhancing mental well-being. By participating, you contribute to advancing scientific knowledge in anxiety reduction, potentially benefiting society at large.

The study employs the General Anxiety Disorder (GAD-7) and Depression, Anxiety and Stress Scales (DASS-21) to measure participants' anxiety levels. These are well-established tools in psychological assessments. The yoga sessions, combined with the calming presence of pythons, are designed to create a unique therapeutic environment.

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. 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.

Personal and Overall Findings

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

Possible Benefits of Participation

Participants may experience a reduction in anxiety levels, improved mental well-being, and increased awareness of personal health through detailed outcome reports. However, 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

Interventional New Drug Application: Python Yoga for Anxiety Reduction

Introduction and Summary of Known Risks

The Python Yoga for Anxiety Reduction program is a novel therapeutic approach that combines yoga with the presence of non-venomous pythons. This treatment aims to explore the potential benefits of this combination in reducing anxiety levels in participants. While this is a unique and innovative approach, it carries certain risks that must be carefully considered.

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.

In the Case of an Adverse Event

If you experience any adverse reactions during the Python Yoga sessions, it is crucial to seek immediate medical attention by calling 911, especially if the reaction seems severe or life-threatening. After addressing any acute situations, please inform Efforia about the incident so that appropriate measures can be taken to ensure your safety and adjust the study protocol if necessary.

Serious Adverse Events (SAEs)

Theoretical Side Effects	Relative Incidence	Recovery
Exacerbation of Anxiety	Low to Moderate	Symptoms typically subside post-session
Physical Injury from Python	Very Low	Immediate medical treatment may be required
Allergic Reactions (e.g., to python)	Low	Typically reversible with proper medical care
Frustration and irritation	Low to Moderate	Typically resolves after ending the session

Additional Identified Risks

• Gastrointestinal Symptoms: Some participants may experience mild nausea or discomfort, particularly if they have a fear of snakes. These symptoms are usually temporary.
• Skin & Hair Reactions: Direct contact with pythons may cause skin irritation or allergic reactions in susceptible individuals. Incidence is low and usually subsides after treatment.
• Mental Health Discomfort: The presence of pythons can initially increase anxiety in some participants. Monitoring and support during sessions are essential to mitigate this risk.

Efforia's Limitations in Providing Direct Medical Support

Efforia is primarily a research organization and does not provide direct medical care. Participants are advised to have access to personal healthcare providers throughout the duration of the study.

Long-term Dependence

No evidence suggests long-term dependence on this treatment, as it is designed to be a short-term, experimental intervention aimed at studying the effects of a unique combination of yoga and exposure to non-venomous pythons.

Legality and Compliance

The Python Yoga for Anxiety Reduction program does not involve any prohibited substances; however, participants should consider the acceptance of this therapy in various settings, including but not limited to workplaces, schools, and competitive sports governed by organizations such as the World Anti-Doping Association (WADA) and the National Collegiate Athletic Association (NCAA).

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: Efforia 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 experience a study-related injury, please seek local medical care first, if necessary. Efforia cannot provide emergency medical care or diagnosis. However, it is important to contact Efforia in the case you experience any problems, have any side effects, or have any study-related injury after you've received any necessary treatment. We want to 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.

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:

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 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:

Data will be collected, used, and protected in compliance with data protection laws. This involves secure data storage, limited access, and anonymization when possible to protect your privacy.

What you can do to improve your privacy and security:

As part of participating in this study, you will receive notifications via e-mail, 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, you should make sure your phone or desktop computer and your e-mail 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: Efforia Privacy Policy.

Who will have access to your data?

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

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.

California Experiential Research Subject’s Bill of Rights:

Participants have rights under the California Experiential Research Subject Bill of Rights. For more information on how Efforia protects your privacy, please review our privacy policy: Efforia 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 (646) 679-2479 OR CLICK THE CHAT BUTTON ON YOUR SCREEN If you are unable to reach anyone at the number(s) listed above and you require immediate (life-threatening) medical attention, please go to the nearest emergency room. If you do not want to talk to the investigator or study staff, if you have concerns or complaints about the research, or to ask questions about your rights as a study subject you may contact Univo IRB. Univo IRB is an independent committee that helps to protect the rights and welfare of research participants. If you have any questions about your rights and welfare as a research participant, or have concerns or complaints regarding this research study, please contact Univo IRB at (919) 910-7743 or via email at info@univo-group.com. Univo IRB
 4509 Creedmoor Road
Suite 403
 Raleigh, NC 27612
 info@univo-group.com (919) 910-7743

Additional questions and closing

Efforia and Univo have approved the information in this consent form and have given approval to publish this study. This does not mean Efforia or Univo have approved your being in the study. You must consider the information in this consent form for yourself and decide if you want to be in this study. 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.