Cold and Heat Investigation to Lower Levels of Depression
Purpose
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.
Conditions
- Depression
- Mood Disorders
Eligibility
- Eligible Ages
- Between 18 Years and 65 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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.
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- Participants who meet inclusion/exclusion criteria will be stratified by use of antidepressant medication and randomized with a 1-to-1 allocation to receive a single session of WBH or a single session of WBH followed immediately by cold plunge (WBH+cold).
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
- Masking Description
- The primary outcome data will be collected by trained raters blinded to participant group assignment and study visit number. The randomization list will be prepared by an unblinded study statistician and administered by study personnel with no other involvement in study activities. The participant will be blinded to their treatment assignment until the end of the WBH treatment, at which point they will be directed to either complete a cool-down period in the sauna device or proceed to the cold plunge.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Active Comparator Whole 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. |
|
|
Active Comparator Whole Body Hyperthermia + Cold 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 lasting up to 10 minutes. |
|
Recruiting Locations
More Details
- Status
- Recruiting
- Sponsor
- Vail Health Behavioral Health
Detailed 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.
