RECRUITING

Cold and Heat Investigation to Lower Levels of Depression

Description

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.

Study Overview

Study Details

Study overview

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.

Cold and Heat Investigation to Lower Levels of Depression

Cold and Heat Investigation to Lower Levels of Depression

Condition
Depression
Intervention / Treatment

-

Contacts and Locations

Edwards

Vail Health Behavioral Health Innovation Center, Edwards, Colorado, United States, 81632

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Meets DSM 5 criteria for major depressive disorder (MDD) with a depressive episode of ≥ 60 days duration.
  • * Montgomery-Asberg Depression Rating Scale (MADRS) score ≥ 28 at screening
  • * 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.
  • * 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.

Ages Eligible for Study

18 Years to 65 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Vail Health Behavioral Health,

Barry Sandler, DO, PRINCIPAL_INVESTIGATOR, Vail Health Behavioral Health

Study Record Dates

2027-04-01