RecruitingNot ApplicableNCT06263738

Cold and Heat Investigation to Lower Levels of Depression


Sponsor

Barry Sandler

Enrollment

162 participants

Start Date

May 14, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria3

  • 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 Criteria4

  • 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.

Interventions

PROCEDUREWhole 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

PROCEDURECold 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.


Locations(1)

Vail Health Behavioral Health Innovation Center

Edwards, Colorado, United States

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NCT06263738


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