Cold and Heat Investigation to Lower Levels of Depression

Last updated: November 11, 2024
Sponsor: Vail Health Behavioral Health
Overall Status: Active - Recruiting

Phase

N/A

Condition

Depression

Affective Disorders

Mood Disorders

Treatment

Cold Water Plunge

Cold Water Plunge

Whole Body Hyperthermia

Clinical Study ID

NCT06263738
20244106
  • Ages 18-65
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Meets DSM 5 criteria for major depressive disorder (MDD) with a depressive episodeof ≥ 60 days duration.

  • Montgomery-Asberg Depression Rating Scale (MADRS) score ≥ 28 at screening

  • English or Spanish speaking (able to provide informed consent and completequestionnaires in one of these languages)

  • Able and willing to adhere to trial requirements, including attending all trialvisits, preparatory and follow-up sessions, and completing all trial evaluations.

Exclusion

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 studyperiod.

  • Endorses current active suicidal ideation with a plan or made a suicide attempt inthe prior 6 months.

Study Design

Total Participants: 112
Treatment Group(s): 4
Primary Treatment: Cold Water Plunge
Phase:
Study Start date:
May 14, 2024
Estimated Completion Date:
April 01, 2027

Study Description

The CHILL'D Study aims to figure out how using heat exposure as a treatment for major depressive disorder (MDD) can work better. The researchers want to see if being exposed to heat followed by cold plunge can help people feel better emotionally compared to just being exposed to heat alone.

The researchers hypothesize that adding cold plunge to heat exposure will enhance the antidepressant effect of heat exposure alone.

To answer study questions, 112 adults, ages 18 to 65 experiencing depression for at least 60 days and who meet study eligibility criteria, will be randomized to receive either 1) a single session of heat exposure or 2) a single session of heat exposure followed immediately by cold plunge.

Participants in the heat exposure alone group will receive a single heat session using the Clearlight Sauna Dome lasting up to 140 minutes. 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 lasting up to 10 minutes.

Connect with a study center

  • Vail Health Behavioral Health Innovation Center

    Edwards, Colorado 81632
    United States

    Active - Recruiting

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