Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
Healthy Volunteers
NCT06263738

Cold and Heat Investigation to Lower Levels of Depression

Led by Barry Sandler · Updated on 2025-11-13

162

Participants Needed

1

Research Sites

150 weeks

Total Duration

On this page

Sponsors

B

Barry Sandler

Lead Sponsor

S

Steadman Philippon Research Institute

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Cold and Heat Investigation to Lower Levels of Depression

Who Can Participate

Age: 18Years - 65Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Individuals who currently meet study criteria for depression or individuals who do not currently meet criteria for depression
  • English or Spanish speaking (able to provide informed consent and complete questionnaires in one of these languages)
  • Able and willing to adhere to trial requirements, including attending all trial visits, preparatory and follow-up sessions, and completing all trial evaluations.
Not Eligible

You will not qualify if you...

  • Previous adverse reaction to hypothermia, hyperthermia and/or infrared exposure
  • Use of any medication that may impact thermoregulatory capacity
  • Pregnancy, active lactation, or intention to become pregnant during the study period
  • Endorses current active suicidal ideation with a plan or made a suicide attempt in the prior 6 months

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Vail Health Behavioral Health Innovation Center

Edwards, Colorado, United States, 81632

Actively Recruiting

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Research Team

S

Study Coordinator

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

4

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