Actively Recruiting
Cold and Heat Investigation to Lower Levels of Depression
Led by Barry Sandler · Updated on 2025-11-13
162
Participants Needed
1
Research Sites
N/A
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 research aims to explore how heat exposure treatments affect adults aged 18 to 65 who are currently experiencing depressive symptoms. The study will compare the effects of a single Whole Body Hyperthermia (heat therapy) session alone versus the same heat session followed immediately by a cold water plunge. The goal is to understand whether adding cold exposure after heat therapy can improve emotional well-being in people with depression. Participants will be randomly assigned to one of two groups. One group will receive a single heat treatment using the Clearlight Sauna Dome for up to 140 minutes. The other group will receive the same heat session followed immediately by a cold water plunge lasting up to 10 minutes in 55-degree Fahrenheit water. A second group of adults without depression will undergo the same treatments for comparison. During the study, participants will complete assessments of their depressive symptoms at baseline, and then again at 1 week and 2 weeks after treatment. Researchers will use tools such as the Montgomery-Åsberg Depression Rating Scale to measure changes in mood. Participants will also complete other questionnaires assessing mental well-being, anxiety, disability, and quality of life. The study will monitor participants throughout the study visits and follow-ups to evaluate the treatment effects on depression.
CONDITIONS
Brief Title
Cold and Heat Investigation to Lower Levels of Depression
Who Can Participate
Eligibility Criteria
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.
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
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single day
Participants receive a single session of heat exposure lasting up to 140 minutes, with some participants also receiving a cold plunge session lasting up to 10 minutes immediately after the heat exposure.
1 treatment visit (in-person)
Duration - 2 weeks
Participants are monitored for changes in depression and well-being with follow-up visits occurring up to 2 weeks after treatment.
2 follow-up visits (in-person) at 1 week and 2 weeks post-treatment
Trial Site Locations
Total: 1 location
1
Vail Health Behavioral Health Innovation Center
Edwards, Colorado, United States, 81632
Actively Recruiting
Research Team
S
Study Coordinator
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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