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Cold and Heat Investigation to Lower Levels of Depression

RECRUITINGN/ASponsored by Barry Sandler
Actively Recruiting
PhaseN/A
SponsorBarry Sandler
Started2024-05-14
Est. completion2027-04-01
Eligibility
Age18 Years – 65 Years
Healthy vol.Accepted
Locations1 site

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.

Eligibility

Age: 18 Years – 65 YearsHealthy volunteers accepted
Inclusion Criteria:

* 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 Criteria:

* 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.

Conditions3

DepressionHealthy (Controls)Mood Disorders

Locations1 site

Vail Health Behavioral Health Innovation Center
Edwards, Colorado, 81632
Study Coordinator970-445-2489BHIC@vailhealth.org

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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