NCT06263738

Cold and Heat Investigation to Lower Levels of Depression

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 162 (estimated)
• Sponsor: Barry Sandler · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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 CHILL'D 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. 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 with 1-to-1 allocation to receive either 1) a single session of heat exposure or 2) a single session of heat exposure followed immediately by cold plunge. A second cohort of up to 50 adults, ages 18 to 65 not experiencing MDD will be randomized with 1-to-1 allocation to the same interventions. 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.

Conditions

• Depression
• Mood Disorders
• Healthy (Controls)

Interventions

Type	Name	Description
PROCEDURE	Whole Body Hyperthermia	Participants in the heat exposure alone group will receive a single heat session using the Clearlight Sauna Dome lasting up to 140 minutes
PROCEDURE	Cold Water Plunge	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 in 55 degree (Fahrenheit) water, lasting up to 10 minutes.

Timeline

• Start date: 2024-05-14
• Primary completion: 2027-04-01
• Completion: 2027-04-01
• First posted: 2024-02-16
• Last updated: 2025-11-13

Locations

1 site across 1 country: United States