30 Day
Sun-Kissed Serenity: Morning Rays for a Brighter Mind
| STUDY TITLE | Sun-Kissed Serenity: Morning Rays for a Brighter Mind |
|---|---|
| Submitted under umbrella | |
| Date submitted |
Apr 17, 2025 |
| End date |
There is no pre-specified end date and sub-studies remain open long-term. |
| Language |
English |
| Efforia AI IRB approval recommendation | |
| Recruitment page preview | |
| Author edit | |
| Informed consent | |
| Study author |
Darci LG, Matthew Amsden, Darci Gross |
| Principal investigator |
Matthew Amsden |
| Sub-Investigator for Adverse Events |
Dr. Viral Patel |
| Description |
Awaken your senses with Sun-Kissed Serenity: a 30-day dawn rendezvous with nature. Bask in morning rays, sans supplements or screens, and explore how nature's glow can enhance mood and mind. Dive into this illuminating study and discover how a simple sunlit start can brighten your day and mind. Simply stand outside for 15 minutes each morning, track your progress with surveys, and bask in the brilliance of natural mental health improvement. |
| Participant engagement length |
30 Days |
| Sponsor |
This study is made possible by your payment to cover all supplies and expenses required to participate. |
| Cost to participant |
$0 |
| Included products & services | |
| Outcome measures |
NIH Toolbox® Item Bank v3.0 – Positive Affect Survey (Ages 18+) Score Personal Feelings Survey |
| Methodology |
Single Arm longitudinal where participants act as their own control |
| Basic or advanced dissemination plan |
Basic |
| Deviation from recruitment approach |
No |
| Deviation from statistical approach |
No |
| Will study include “more about you questions” |
No |
| Clinicaltrials.Gov |
Yes |
| Committment to list findings on clinicaltrials.Gov |
Yes |
Preview This document is prepared with the assistance of AI, but is reviewed by a human.
Rational & Study Design
The Intervention
Included Products & Services
Study Design & Methodology
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.
| Category of Individual | Contraindications | Reason |
|---|---|---|
| Individuals with skin conditions (e.g., lupus, rosacea) | Should avoid or limit sunlight exposure | Sunlight may exacerbate skin conditions, leading to flare-ups or worsening of symptoms. |
| Individuals with a history of skin cancer or high risk for cancer | Should avoid excessive UV exposure | Increased UV exposure can elevate the risk of skin cancer. |
| Individuals taking photosensitizing medications (e.g., certain antibiotics, diuretics) | Should avoid sunlight or consult with healthcare provider | These medications can increase sensitivity to sunlight, leading to burns or other skin damage. |
| Individuals with a history of eye disorders (e.g., cataracts, macular degeneration) | Should use protective eyewear or consult with an ophthalmologist | Sunlight exposure without protection can worsen eye conditions or cause discomfort. |
| Individuals with a history of heat-related illnesses | Should avoid or limit exposure during high temperatures | Sunlight exposure can increase the risk of heat exhaustion or heatstroke. |
| Individuals with irregular sleep patterns or sleep disorders | Should monitor sleep changes | Changes in sunlight exposure might disrupt sleep patterns further, impacting cognitive and physical health. |
| Individuals with mental health conditions sensitive to changes in routine | Should consult a mental health professional | Disruption in daily routine or unexpected effects on mood could exacerbate mental health issues. |
| Individuals with restricted sunlight exposure due to religious or cultural practices | Should evaluate personal and cultural guidelines | Participation might conflict with personal or cultural beliefs or practices. |
Study Design & Experience
Daily Activity: Spend 15 minutes in morning sunlight within the first 30 minutes of waking to support mental well-being.
Assesments and frequency:- NIH Toolbox® Item Bank v3.0 – Positive Affect Survey (Ages 18+): Conducted periodically.
- Personal Feelings Survey: Conducted periodically.
The study titled "Rise & Shine: Morning Sunlight for Mental Clarity" seeks to investigate the impact of natural sunlight exposure on mental health. This research involves participants spending 15 minutes in direct morning sunlight within 30 minutes of waking, every day for 30 days. This observational trial operates under a single-arm design where participants serve as their own control group. At Efforia, this approach is part of a "Signal Phase" study, aimed at identifying potential positive effects of morning sunlight on mood, mental clarity, and stress levels. By focusing on this simple, nature-based intervention without the use of supplements or devices, the study aims to provide preliminary insights into how daily sunlight exposure might serve as a natural support for mental health.
Participants in this study will engage in a straightforward and natural intervention, contributing to valuable research on the real-world benefits of morning sunlight exposure. They will receive reminders, such as linking their Google Calendar or Todoist, to facilitate consistency in their daily routine. The study emphasizes confidentiality and privacy, ensuring that all responses are anonymized. By committing to this 30-day sunlight exposure, participants not only support their mental well-being but also play a critical role in exploring the potential benefits of this natural habit. This Signal Phase trial aims to gather initial data that could indicate positive trends in mental health support through morning sunlight exposure.
Should the findings from this Signal Phase indicate that morning sunlight effectively enhances mental clarity and mood, Efforia plans to consider more comprehensive study designs. The current trial will also generate essential safety data, which is currently scarce. By serving as an initial step in understanding the benefits of morning sunlight, this study could pave the way for larger-scale research efforts. The potential positive outcomes from this trial could lead to broader applications and recommendations for using natural sunlight as a mental health intervention. For more detailed information, refer to the "Minimal Risk Umbrella protocol."
Statistical Analysis Plan
Limitations & Justification
In conducting this single-arm observational trial under the Minimal Risk Citizen Science Umbrella Protocol, we recognize and address several inherent limitations. The absence of a control group is a notable limitation, as it may introduce bias and affect the robustness of causal inferences. To mitigate this, we have included an expectations questionnaire to quantify and understand how participant expectations might influence the outcomes. This methodological choice aims to capture subjective bias, allowing for a nuanced interpretation of the results. While the trial's design does not allow for direct comparison with a control group, the use of validated tools such as the NIH Toolbox® Positive Affect Survey and the Personal Feelings Survey ensures that the measurements of mood and stress are rigorous and reliable.
The study’s sample size and statistical approach are another focal point for addressing potential biases. Although single-arm trials often face criticisms regarding generalizability, our decision to stratify data by participant demographics enhances the study’s capacity to identify significant patterns and correlations across diverse population subsets. This stratification, coupled with a commitment to recruit a broad participant pool via Efforia's platforms, maximizes the ecological validity and potential applicability of our findings. As a signal detection study, our primary goal is to identify initial trends that could justify further exploration through more comprehensive, controlled trials. This strategic progression underscores our dedication to ensuring that any observed effects are valid and replicable.
Efforia and the Minimal Risk Umbrella Protocol are committed to democratizing research by supporting studies and researchers that might otherwise be overlooked. This trial exemplifies that mission by focusing on a low-cost, accessible intervention with the potential to impact mental health positively. By creating a platform that empowers participants to contribute to scientific knowledge, we not only advance research in natural mental health interventions but also champion a participatory approach to healthcare discovery. For more detailed information on the overarching framework and research ethos, we encourage interested individuals to explore the Minimal Risk Umbrella Protocol.
Human Subjects Ethics
Suitability Under Minimal Risk Umbrella Protocol
The protocol "Rise & Shine: Morning Sunlight for Mental Clarity" appears to be suitable for the minimal risk umbrella protocol. This study likely involves examining the effects of morning sunlight exposure on mental clarity, which fits well within the criteria for minimal risk studies as it involves a natural and non-invasive intervention. Sunlight is a legal, easily accessible intervention that does not require a prescription or physician diagnosis, and it is generally recognized as safe (GRAS). The focus on mental clarity and wellness aligns with the umbrella protocol's emphasis on enhancing general health and productivity. Additionally, the study likely falls within the "health and wellness" domain, exploring natural methods to improve well-being, thus making it a suitable candidate.
Moreover, the study does not appear to involve vulnerable populations or require any medical diagnoses or prescriptions, which aligns with the protocol's guidelines. The intervention does not involve regulated pharmaceuticals, medical devices, or banned substances, nor does it include blinding or deception. It also likely does not require more than two blood draws, if any, and does not have any illegal components. The longitudinal nature of the study, assuming it spans several days, also fits within the set parameters. Therefore, the "Rise & Shine: Morning Sunlight for Mental Clarity" protocol meets the necessary criteria and is suitable for inclusion under the minimal risk umbrella protocol.
Suitability for Pay to Participate Model
The Rise & Shine: Morning Sunlight for Mental Clarity study offers a unique opportunity for participants to explore the benefits of natural sunlight on mental health without any financial burden, as the price is set at zero. This study harnesses a widely accessible, free resource—sunlight—to investigate its potential impacts on mood, mental clarity, and stress reduction. Since no products, services, or additional information are being sold or required for purchase, participants can easily integrate this daily practice into their routine without incurring costs, making it an equitable and inclusive study for individuals across various socioeconomic backgrounds.
Given the study's nature, there are no concerns about financial hardship or buyer's remorse, as participants do not need to pay for any products or services. Sunlight is legally available and free to access in the countries where the protocol will operate, and people are generally willing to engage in this type of natural practice. The study provides additional value by offering a structured approach to incorporating sunlight exposure into daily routines, potentially yielding significant mental health benefits. This approach empowers participants to make informed, data-driven decisions about their health without any financial barriers, supporting the principles of respect for persons, justice, and beneficence.
Human Subjects Protection Questionnaire
Beneficence
Is there a description, unambiguous research question, and purpose?
Yes, the study has a clear research question and purpose, focusing on evaluating the effectiveness of a behavior anyone can do. This provides a structured framework for assessing the outcomes of the intervention.Is the study built on what is known already?
Yes, the study builds on existing knowledge by evaluating a behavior anyone can do, leveraging previously gathered data and user experiences to inform the research design.Will the study provide meaningful answers to the research question?
Yes, the study is designed to generate both generalizable results and specific insights relevant to the participants, thereby offering meaningful answers to the research question and enhancing the value for those who have purchased the product.Will the study provide valid answers to the research question?
Yes, the study's design and methodology are structured to provide valid answers to the research question by focusing on measurable outcomes and employing rigorous data collection and analysis techniques.
Non-maleficence
Are participants recruited with justifiable inclusion and exclusion criteria?
Yes, any individual who has already purchased the product is eligible to participate. Efforia emphasizes participant responsibility for identifying if the protocol is not suitable for them through clear risks and considerations outlined in the informed consent.Does the research team have the experience, skills, facilities, and time to complete the study?
Yes, the research team is well-equipped to conduct the study, benefiting from Efforia's decentralized structure and minimal risk protocols. They have extensive infrastructure in place and are supported by experienced professionals like Matthew Amsden and Dr. Viral Patel, ensuring comprehensive oversight and support in case of adverse events.Is there a fair balance of benefits and harms (risks) for all with an interest in the study?
Yes, the study's unique approach, as outlined in the minimal risk protocol, provides added value to participants by offering a product or service without additional cost while ensuring minimal risk.Will participants receive appropriate care both during and after the study?
Yes, participants are advised to seek their own medical care in the event of an adverse event. However, being part of the study offers them additional care through adverse event monitoring, which is not generally available for such interventions on the open market.Is personal data handled appropriately (confidentiality)?
Yes, the study adheres to the guidelines set out in the Minimal Risk Umbrella protocol to ensure that personal data is handled with strict confidentiality.
Autonomy
Have participants been offered a fair choice through the information they are given (presented in plain English) and consent process?
Yes, the informed consent document is designed to provide clear and comprehensive information about the study, its risks, benefits, and the voluntary nature of participation, allowing participants to make informed decisions.Has the research incorporated patient and participant views?
Yes, Efforia's platform is inherently participant-driven, and this study incorporates participant feedback regarding their experiences with the treatment. The consent document also encourages participants to provide input and ask questions throughout the study.
Justice
Are there fair payments for participation and financial recompense in case of harm?
Yes, while participants pay to participate, they receive a valuable product and health outcome tracking. In case of adverse events, they are instructed to seek medical care and report incidents to Efforia, accepting that medical care costs are their responsibility.Do participants have access to an independent complaints procedure (or advocate)?
Yes, participants can contact Efforia's support for any concerns or complaints, and independent ethics review board contact numbers are included in the informed consent for those preferring external communication.Will the project be registered and results reported in the public domain?
Yes, Efforia commits to transparency by making personal results available to participants immediately, and authors aim to publish generalizable results to establish credibility.