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

Vail Health Behavioral Health

Status: Enrolling

Conditions: Depression; Mood Disorders

Treatments: Procedure: Cold Water Plunge; Procedure: Whole Body Hyperthermia

Study type: Interventional

Funder types: Other

Identifiers

NCT06263738

20244106

Details and patient eligibility

About

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.

Full 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.

Enrollment: 112 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion 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.

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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112 participants in 2 patient groups

Whole Body Hyperthermia

Active Comparator group

Description:

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

Treatment:

Procedure: Whole Body Hyperthermia

Whole Body Hyperthermia + Cold Water Plunge

Active Comparator group

Description:

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.

Treatment:

Procedure: Whole Body Hyperthermia

Procedure: Cold Water Plunge