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120 Day

Cold Exposure Mental Health Protocol

STUDY TITLE Cold Exposure Mental Health Protocol
Submitted under umbrella

Minimal Risk Citizen Science Umbrella Protocol

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

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Author edit

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Informed consent

Review

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.

[lifterlms_course_continue_button]
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

The Cold Exposure Mental Health Protocol assesses the impact of daily ice baths on mental well-being, amid growing social media interest and preliminary scientific support suggesting potential benefits such as enhanced mood and mental clarity. While popular belief and anecdotal evidence advocate for its efficacy, robust scientific data remains limited. This study aims to provide empirical evidence to either confirm or refute these claims, using validated psychological assessments over 130 days, thus contributing to a better understanding of the risks and benefits associated with regular cold exposure.

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

Date Event Message Name
Sep 07, 2024 16:56:01 modified Created the entry last_activity in the user profile ruthiedellit72.
Role: author_organization, bbp_participant
First name:
Last name:
Custom field value: 2024-09-07 16:55:58
User profile page 		ruthiedellit72
Sep 07, 2024 16:55:56 modified Created the entry bb_read_notification_migration in the user profile ruthiedellit72.
Role: author_organization, bbp_participant
First name:
Last name:
Custom field value: 1
User profile page 		ruthiedellit72
Sep 06, 2024 20:10:17 modified Changed the value of the entry last_activity in the user profile yuvxgusepcapqdmb.
Role: author_organization, bbp_participant
First name:
Last name:
Previous value: 2024-09-06 20:10:09
New value: 2024-09-06 20:10:15
User profile page
Exclude entry from the monitoring 		yuvxgusepcapqdmb
Sep 06, 2024 20:10:12 modified Changed the value of the entry last_activity in the user profile yuvxgusepcapqdmb.
Role: author_organization, bbp_participant
First name:
Last name:
Previous value: 2024-09-06 20:10:03
New value: 2024-09-06 20:10:09
User profile page
Exclude entry from the monitoring 		yuvxgusepcapqdmb
Sep 06, 2024 20:10:11 modified Changed the value of the entry eff_user_timezone in the user profile yuvxgusepcapqdmb.
Role: author_organization, bbp_participant
First name:
Last name:
Previous value: America/Fortaleza
New value: UTC
User profile page
Exclude entry from the monitoring 		yuvxgusepcapqdmb
Sep 06, 2024 20:10:11 modified Changed the value of the entry description in the user profile yuvxgusepcapqdmb.
Role: author_organization, bbp_participant
First name:
Last name:
Previous value:
New value: OfBipLTGPCA
User profile page
Exclude entry from the monitoring 		yuvxgusepcapqdmb
Sep 06, 2024 20:10:06 modified Changed the value of the entry last_activity in the user profile yuvxgusepcapqdmb.
Role: author_organization, bbp_participant
First name:
Last name:
Previous value: 2024-09-06 20:09:57
New value: 2024-09-06 20:10:03
User profile page
Exclude entry from the monitoring 		yuvxgusepcapqdmb
Sep 06, 2024 20:10:00 modified Changed the value of the entry last_activity in the user profile yuvxgusepcapqdmb.
Role: author_organization, bbp_participant
First name:
Last name:
Previous value: 2024-09-06 20:09:51
New value: 2024-09-06 20:09:57
User profile page
Exclude entry from the monitoring 		yuvxgusepcapqdmb
Sep 06, 2024 20:09:54 modified Changed the value of the entry last_activity in the user profile yuvxgusepcapqdmb.
Role: author_organization, bbp_participant
First name:
Last name:
Previous value: 2024-09-06 20:09:33
New value: 2024-09-06 20:09:51
User profile page
Exclude entry from the monitoring 		yuvxgusepcapqdmb
Sep 06, 2024 20:09:35 modified Created the entry last_activity in the user profile yuvxgusepcapqdmb.
Role: author_organization, bbp_participant
First name:
Last name:
Custom field value: 2024-09-06 20:09:33
User profile page 		yuvxgusepcapqdmb
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