Cold and Heat Investigation to Lower Levels of Depression
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Whole Body Hyperthermia, Cold Water Plunge.
- Who it may be relevant to
- Registry conditions: Depression, Mood Disorders, Healthy (Controls). Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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.
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.
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 with 1-to-1 allocation to receive either 1) a single session of heat exposure or 2) a single session of heat exposure followed immediately by cold plunge.
A second cohort of up to 50 adults, ages 18 to 65 not experiencing MDD will be randomized with 1-to-1 allocation to the same interventions.
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.
Interventions
- Procedure 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 - Procedure 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 in 55 degree (Fahrenheit) water, lasting up to 10 minutes.
Primary outcome measures
- Montgomery-Åsberg Depression Rating Scale (MADRS) [Time frame: Baseline/Treatment (Visit 1), 1 Week Post-Treatment (Visit 2), 2 Weeks Post-Treatment (Visit 3)]
Secondary outcome measures (4)
- Warwick Edinburgh Mental Well-Being Scale (WEMWBS) [Time frame: Baseline/Treatment (Visit 1), 1 Week Post-Treatment (Visit 2), 2 Weeks Post-Treatment (Visit 3)]
- Patient Reported Outcome Measure Information System (PROMIS) 8A - Anxiety [Time frame: Baseline/Treatment (Visit 1), 1 Week Post-Treatment (Visit 2), 2 Weeks Post-Treatment (Visit 3)]
- Sheehan Disability Scale (SDS) [Time frame: Baseline/Treatment (Visit 1), 1 Week Post-Treatment (Visit 2), 2 Weeks Post-Treatment (Visit 3)]
- Quality of Life Enjoyment & Satisfaction Questionnaire Short Form (Q-LES-Q SF) [Time frame: Baseline/Treatment (Visit 1), 1 Week Post-Treatment (Visit 2), 2 Weeks Post-Treatment (Visit 3)]
Eligibility criteria
Inclusion criteria
- 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 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Vail Health Behavioral Health Innovation Center — Edwards
Identifiers
NCT: NCT06263738 · 20244106