Ignite Creation Date:
2024-05-06 @ 8:07 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06263738
Status:
RECRUITING
Last Update Posted:
2024-05-16
First Post:
2024-02-08
Brief Title:
Cold and Heat Investigation to Lower Levels of Depression
Sponsor:
Vail Health Behavioral Health
Organization:
Vail Health Behavioral Health
Study Overview
Official Title:
Cold and Heat Investigation to Lower Levels of Depression
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CHILLD
Brief Summary:
This study will recruit 112 medically healthy adults aged 18-65 currently experiencing depressive symptoms to be randomized to receive either a single Whole Body Hyperthermia heat therapy treatment or a Whole Body Hyperthermia treatment followed by a cold water plunge Participants will complete a baseline assessment of their depressive symptoms as well as 1-week and 2-week post-treatment followup assessments
Detailed Description:
The CHILLD Study aims to figure out how using heat exposure as a treatment for major depressive disorder MDD can work better The researchers want to see if being exposed to heat followed by cold plunge can help people feel better emotionally compared to just being exposed to heat alone
The researchers hypothesize that adding cold plunge to heat exposure will enhance the antidepressant effect of heat exposure alone
To answer study questions 112 adults ages 18 to 65 experiencing depression for at least 60 days and who meet study eligibility criteria will be randomized to receive either 1 a single session of heat exposure or 2 a single session of heat exposure followed immediately by cold plunge
Participants in the heat exposure alone group will receive a single heat session using the Clearlight Sauna Dome lasting up to 140 minutes Participants in the heat exposure and cold plunge group will receive a single heat session using the Clearlight Sauna Dome lasting up to 140 minutes followed by a cold plunge session lasting up to 10 minutes
The researchers hypothesize that adding cold plunge to heat exposure will enhance the antidepressant effect of heat exposure alone
To answer study questions 112 adults ages 18 to 65 experiencing depression for at least 60 days and who meet study eligibility criteria will be randomized to receive either 1 a single session of heat exposure or 2 a single session of heat exposure followed immediately by cold plunge
Participants in the heat exposure alone group will receive a single heat session using the Clearlight Sauna Dome lasting up to 140 minutes Participants in the heat exposure and cold plunge group will receive a single heat session using the Clearlight Sauna Dome lasting up to 140 minutes followed by a cold plunge session lasting up to 10 minutes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None