Summary Information to Help you Decide Whether to Join this Study

Study Title	Porn Abstinence Impact Challenge: Stress Test
Study Author	Jordan Tsanev, Christos Konstantinidis, Matthew Amsden
Sponsor	This study is made possible by your payment to join.
Cost of Products, Services & Information to Participant	$0
Included Products & Services	This study includes no additional products and services.
Outcome Measures	Weekly Porn Consumption Survey, Sexual Desire Inventory-2 (SDI-2) Survey for Men & Women, International Index of Erectile Function Survey, Perceived Stress Scale (Past Week Version)
Contact	help@efforia.com

Introduction & Summary

Welcome to this exciting opportunity to join our research study on the Efforia platform. This study is possible thanks to your participation. We're here to help you explore the reasons you might want to join this study, or why it might not be right for you. Our goal is to understand the effects of abstaining from pornography over a 40-day period. Your participation is voluntary, and you can leave the study at any time without penalty. We encourage you to ask any questions you may have before deciding to join.

Purpose of the Study

The Porn Abstinence Impact Challenge aims to investigate the effects of abstaining from pornography on stress regulation, sexual performance, and emotional resilience. By using a series of validated surveys, including the Sexual Desire Inventory-2 (SDI-2) and the Perceived Stress Scale, we aim to contribute to scientific knowledge about personal behavior changes and their broader societal impact. Participants will engage in self-assessment activities that enhance awareness and potentially inform personal health decisions.

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

It's important 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 as well as overall findings as they become available. These findings may impact your interest and willingness to remain involved in the study. Remember, your participation is voluntary, and you may exit at any time by sending an e-mail to help@efforia.com.

Possible Benefits of Participation

Participating in this study may provide personal insights into your behavior, stress levels, and sexual health. You'll have the opportunity to engage in self-reflection and potentially make informed personal health decisions based on your findings. Additionally, your participation will contribute to broader scientific knowledge that may benefit others. However, there is a possibility that there will be no measurable benefit to you, other than seeing reports that the intervention had no measurable impact.

Possible Serious Adverse Events & Side Effects

Introduction and Summary of Known Risks

The intervention under review, titled "Porn Abstinence Impact Challenge: Stress Test", is an experimental approach aimed at exploring the effects of abstaining from pornography on stress levels, sexual health, and overall well-being. This method is based on self-experimentation and self-reporting, making it unique but also potentially unpredictable in terms of outcomes and 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.

In the Case of an Adverse Event

If you experience any adverse events or unexpected symptoms during the course of this self-experimentation, it is crucial to seek immediate medical care by dialing 911, especially if the symptoms are severe or life-threatening. Once any acute situations have been addressed, please inform Efforia about the incident so that it can be documented and addressed appropriately in future iterations of the study.

Serious Adverse Events (SAEs)

Serious Adverse Events associated with this treatment are not explicitly documented due to the nature of the intervention; however, potential SAEs can arise from psychological distress or emotional instability triggered by abstaining from habitual behaviors such as pornography use. These events may include severe mental health crises that could lead to hospitalization or persistent psychological discomfort.

Theoretical Side Effects Table

Theoretical side effects	Relative incidence	Recovery
Mood changes	Medium likelihood	Symptoms subside with continuation or cessation of the experiment
Sleep disturbances	Low to medium likelihood	Symptoms subside post-treatment
Cognitive impairment	Low likelihood	Reversible upon completion of the experiment
Mental health discomfort	Medium to high likelihood	May need psychological intervention
Frustration and irritation	High likelihood	Symptoms subside with continuation or cessation of the experiment

Certain Individuals Should Carefully Consider Whether They Should Join this Study

Please speak to a qualified professional if you fall into any of the following categories before joining this study. 

Category of Individual	Contraindications	Reason
Individuals with Mental Health Disorders	History of depression, anxiety, or other mental health issues	Possible exacerbation of symptoms due to psychological distress or emotional instability triggered by abstinence.
Individuals with PTSD	History of trauma that could be exacerbated by stress	Potential for re-triggering trauma-related stress or mental health crises.
Individuals with Addiction Issues	Current or past addiction to pornography or other substances	Risk of withdrawal-like symptoms and potential mental health crises due to abstaining from habitual behaviors.
Individuals with Sleep Disorders	Pre-existing insomnia or other sleep disturbances	Risk of exacerbating sleep disturbances as a side effect of the intervention.
Individuals Undergoing Psychiatric Treatment	Currently undergoing treatment for psychiatric conditions	Interference with treatment regimen and potential for adverse psychological effects.
Individuals with Chronic Stress	High baseline stress levels or stress-related health issues	Risk of increased stress or health complications due to changes in habitual behavior.
Individuals with Cognitive Disorders	Pre-existing cognitive impairments	Potential worsening of cognitive symptoms as a side effect of the intervention.
Individuals in Healthcare Transition	Undergoing significant life changes or adjustments in healthcare regimen	Additional stress from the intervention may complicate ongoing treatment or adjustments.
Pregnant Individuals	Pregnancy or planning to become pregnant during the study period	Individuals may want to avoid participation in research studies when pregnant or considering pregnancy.

 

 

Efforia's Limitations in Providing Direct Medical Support

It is important to note that Efforia does not provide direct medical support or emergency services. Participants are advised to rely on their healthcare providers for any medical assistance and should not treat the intervention as a substitute for professional medical advice or treatment.

This document serves as a comprehensive overview of the potential risks associated with the "What Have You Gotten Yourself Into?" experiment. Participants are encouraged to proceed with caution and full awareness of the potential psychological impacts and institutional implications.

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

Seek local medical care first if necessary. Efforia cannot provide emergency medical care or diagnosis. However, it is important to contact Efforia if 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 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:

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. 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:

Efforia is committed to protecting your data. All data will be collected, used, and protected in compliance with data protection laws.

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: https://efforia.com/privacy-policy.

Who will have access to your data?

Efforia will have access to your data. There may also be partners who have access to your data, such as 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.

California Experiential Research Subject’s Bill of Rights:

Participants are encouraged to review the California Experiential Research Subject Bill of Rights. Full details on your privacy and data protection rights can be found in Efforia's privacy policy, accessible at 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
(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.