Cold and Heat Investigation to Lower Levels of Depression (CHILL'D Study)

This study, called the CHILL'D Study, is looking into how heat therapy, sometimes with a cold plunge, might help people with depression. Researchers want to see if a single session of Whole Body Hyperthermia (heat therapy) followed by a cold water plunge works better to improve mood than just the heat therapy alone. You might be able to join if you are 18 to 65 years old and are currently experiencing symptoms of depression, or if you do not have depression but want to participate as a healthy control. The study will measure changes in your depression symptoms using a scale called the Montgomery-Åsberg Depression Rating Scale (MADRS) at the start, and then one and two weeks after treatment. The current recruitment status is unclear.

Study design
This is an interventional study planning to enroll 162 participants, including those with depression and healthy controls. Participants will be randomly assigned to receive either heat therapy alone or heat therapy followed by a cold plunge.
What's involved
Participants will attend a baseline assessment, a single treatment session lasting up to 140 minutes (with an additional 10 minutes for cold plunge if assigned), and follow-up assessments one and two weeks after treatment.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for two weeks after their treatment session to assess changes in depression symptoms.

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NCT06263738

Cold and Heat Investigation to Lower Levels of Depression

Recruiting
NAAges 18–65InterventionalTreatment
Barry Sandler
~162 participants
Updated 2025-11-13 on ClinicalTrials.gov
What's tested:Whole Body HyperthermiaCold Water Plunge

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Montgomery-Åsberg Depression Rating Scale (MADRS)
Measured over Baseline/Treatment (Visit 1), 1 Week Post-Treatment (Visit 2), 2 Weeks Post-Treatment (Visit 3)
Depression
Mood Disorders
Healthy (Controls)
1 sites across 1 states
Colorado1
  • Barry Sandler, DO · PRINCIPAL_INVESTIGATOR · Vail Health Behavioral Health

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Eligibility criteria

Inclusion

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.

Exclusion

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.
  • Montgomery-Åsberg Depression Rating Scale (MADRS)Baseline/Treatment (Visit 1), 1 Week Post-Treatment (Visit 2), 2 Weeks Post-Treatment (Visit 3)

    The MADRS is a validated 10-item questionnaire to assess depression severity and is commonly used to assess efficacy of an intervention in clinical trials. Each item of the MADRS is measured on a scale of 0 to 6 (for a total score of 0 to 60) with higher scores indicating more severe depression. The MADRS includes questions on the following symptoms: 1. Reported sadness; 2. Apparent sadness; 3. Inner tension; 4. Reduced sleep; 5. Reduced appetite; 6. Concentration difficulties; 7. Lassitude; 8. Inability to feel; 9. Pessimistic thoughts; 10. Suicidal thoughts. Items are scored via a clinical interview that progresses from more broadly phrased questions about symptoms to more detailed queries that allow a precise rating of severity.