120 Day
Cold Exposure Mental Health Protocol
STUDY TITLE | Cold Exposure Mental Health Protocol |
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Submitted under umbrella | |
Date submitted |
- |
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 |
Ivan Fedkiv, Matthew Amsden |
Principal investigator |
Matthew Amsden |
Sub-Investigator for Adverse Events |
Dr. Viral Patel |
Description |
Participants will engage in a daily ice bath regimen designed to evaluate the effects of regular cold exposure on mental well-being. The intervention involves a structured schedule of daily ice baths without any additional assessments using surveys to prevent bias in self-reported outcomes. |
Participant engagement length |
120 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 |
36-Item Short Form Survey Instrument (SF-36) NIH Toolbox® Item Bank v3.0 – Positive Affect Survey (Ages 18+) Score |
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” |
Yes |
Recruitment jurisdictions |
United States, United Kingdom |
Clinicaltrials.Gov |
Yes |
Committment to list findings on clinicaltrials.Gov |
Yes |
This document is prepared with the assistance of AI, but is reviewed by a human.
Rational & Study Design
Why I created this challenge:
Research and social media both buzz about the benefits of cold exposure, suggesting improvements in mental clarity and mood. Academic studies hint at physiological mechanisms, like increased endorphin levels, that could underpin these benefits. However, robust evidence linking regular ice bath routines to mental health improvements remains sparse. This challenge aims to bridge that gap, providing solid data to support or refute widespread beliefs about the power of cold exposure.
My Objective for You:
To systematically assess how a daily regimen of ice baths impacts your mental well-being, using scientifically validated tools like the SF-36 and NIH Positive Affect Survey, over 130 days.
Aims & Objectives:
This challenge aims to quantify changes in mental health outcomes, specifically through validated measures of well-being and positive affect. The objectives are to establish a clear link between regular cold exposure and improvements in these metrics or to challenge the existing anecdotal evidence.
Significance & Impact:
The significance of this study lies in its potential to scientifically validate or challenge the anecdotal benefits of cold exposure on mental health. Expected outcomes include a clearer understanding of how such practices affect well-being. This challenge, despite its rigorous approach, may face limitations in controlling for external variables that impact mental health, such as lifestyle changes or seasonal effects.
The Intervention
Included Products & Services
Study Design & Methodology
Inappropriate Participants & Inclusion/Exclusion
Study Design & Experience
Statistical Analysis Plan
Limitations & Justification
Human Subjects Ethics
Suitability Under Minimal Risk Umbrella Protocol
Suitability for Pay to Participate Model
Human Subjects Protection Questionnaire
Logging
Logging
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Dec 07, 2024 14:23:19 | modified | qrvrczvy | |
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