DepressionCHILL'DNCT06263738
Cold and Heat Investigation to Lower Levels of Depression
A study testing Whole Body Hyperthermia and Cold Water Plunge in people with Depression and Mood Disorders, run by Barry Sandler at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression, Mood Disorders, Healthy (Controls)
- What is being tested?
- Whole Body Hyperthermia and Cold Water Plunge
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- 1 siteUnited States
- Study dates
- 14 May 2024to 1 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Vail Health Behavioral Health Innovation Center
Edwards, Colorado, 81632
Study Coordinator, 970-445-2489, BHIC@vailhealth.org
Barry Sandler, DO
About this study
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.
Read the 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.
- Conditions
- Depression, Mood Disorders, Healthy (Controls)
- Being tested
- Whole Body Hyperthermia, Cold Water Plunge
- Keywords
- Depression, Mood Disorders, Mental Health, Integrative Health, Hyperthermia, Sauna, Cold Plunge
- Medical subject headings
- Depression, Mood Disorders, Psychological Well-Being, Hyperthermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole Body HyperthermiaProcedure or surgery
Also called Infrared Sauna, Whole Body Heating
Participants in the heat exposure alone group will receive a single heat session using the Clearlight Sauna Dome lasting up to 140 minutes
Cold Water PlungeProcedure or surgery
Also called Cold Plunge, Cold Water Exposure
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.
| Study group | Role | What they receive |
|---|---|---|
| Depression + Whole Body Hyperthermia | Active comparator | Participants experiencing depression will receive a single heat treatment using the Clearlight Sauna Dome lasting up to 140 minutes. Receives: Procedure: Whole Body Hyperthermia |
| Depression + Whole Body Hyperthermia + Cold Water Plunge | Active comparator | Participants experiencing depression 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. Receives: Procedure: Whole Body Hyperthermia; Procedure: Cold Water Plunge |
| No Depression + Whole Body Hyperthermia | Active comparator | Participants not experiencing depression will receive a single heat treatment using the Clearlight Sauna Dome lasting up to 140 minutes. Receives: Procedure: Whole Body Hyperthermia |
| No Depression + Whole Body Hyperthermia + Cold Water Plunge | Active comparator | Participants not experiencing depression 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. Receives: Procedure: Whole Body Hyperthermia; Procedure: Cold Water Plunge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Montgomery-Åsberg Depression Rating Scale (MADRS)
The MADRS is a validated 10-item questionnaire to assess depression severity and is commonly used to assess efficacy of an intervention in clinical trials. Each item of the MADRS is measured on a scale of 0 to 6 (for a total score of 0 to 60) with higher scores indicating more severe depression. The MADRS includes questions on the following symptoms: 1. Reported sadness; 2. Apparent sadness; 3. Inner tension; 4. Reduced sleep; 5. Reduced appetite; 6. Concentration difficulties; 7. Lassitude; 8. Inability to feel; 9. Pessimistic thoughts; 10. Suicidal thoughts. Items are scored via a clinical interview that progresses from more broadly phrased questions about symptoms to more detailed queries that allow a precise rating of severity.
Measured: Baseline/Treatment (Visit 1), 1 Week Post-Treatment (Visit 2), 2 Weeks Post-Treatment (Visit 3)
Secondary outcomes (4)
Warwick Edinburgh Mental Well-Being Scale (WEMWBS)
The WEMWBS was designed to measure the psychological well-being of a population and has been shown to be responsive to novel interventions such as psychedelics. WEMWBS has 14 questions scored using a five-point Likert scale. The items are all worded positively and cover both feeling and functioning aspects of mental wellbeing. Items on the questionnaire are rated on a 5-point scale, where 1= "None of the time", 2= "rarely", 3= "some of the time", 4= "often", 5= "all the time". Scores reflect feelings and thoughts in the two weeks prior to answering the questionnaire. The WEMWBS assesses both emotional and functional aspects of mental well-being. Total scores range from 14 to 70, with higher scores correlating to higher levels of well-being.
Measured: 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
The PROMIS Anxiety measure focuses on fear (e.g., worry, feelings of panic), anxious misery (e.g., dread), hyperarousal (e.g., tension, nervousness, restlessness), and somatic symptoms related to arousal (e.g., cardiovascular symptoms, dizziness) and has been found to be a clinically validated measure of anxiety. The PROMIS 8A--Anxiety is comprised of eight items, each rated on a scale from 1 ("Never") to 5 ("Always"). Total scores range from 8 to 40, with higher scores correlating to higher levels of anxiety.
Measured: Baseline/Treatment (Visit 1), 1 Week Post-Treatment (Visit 2), 2 Weeks Post-Treatment (Visit 3)
Sheehan Disability Scale (SDS)
The SDS is a composite of 3 self-rated items designed to measure the extent to which 3 major sectors in the patient's life are impaired by psychiatric symptoms, including depression. This scale has been used widely in psychopharmacology randomized, controlled trials and has been accepted by the Food and Drug Administration (FDA) for functional disability labeling. The SDS uses visual-spatial, numeric, and verbal descriptive anchors simultaneously to assess disability across 3 domains: work, social life, and family life. The SDS asks participants to rate the extent to which their 1) work/school, 2) social life or leisure activities, and 3) home life or family responsibilities are impaired by his or her symptoms on a 10-point visual analogue scale. Total scores range from 0 to 30, with higher scores correlating to higher levels of disability.
Measured: 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)
The Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form version contains 16 items assessing changes in quality of life, divided into the following sections: physical health, feelings, work, household duties, school, leisure time activities, social relations, and general activities. A total score is derived from summing the first 14 items on the scale, with the last 2 items serving as stand-alone queries. Total score ranges from 14 to 70, with higher scores correlating with higher levels of quality of life.
Measured: Baseline/Treatment (Visit 1), 1 Week Post-Treatment (Visit 2), 2 Weeks Post-Treatment (Visit 3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2024
- Study start14 May 2024
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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).
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 162 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Barry Sandler
- Sponsor type
- University, hospital or other
- Collaborators
- Steadman Philippon Research Institute
- Responsible party
- Sponsor-investigator, Barry Sandler, Vail Health Behavioral Health
- Investigators
- Barry Sandler, DO, Principal investigator, Vail Health Behavioral Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06263738
- Sponsor's protocol ID
- 20244106
- Acronym
- CHILL'D
- Status last verified
- Nov 2025
- First submitted
- 8 Feb 2024
- Last updated
- 13 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data including, but not limited to, demographics, questionnaires, and adverse events will be made available upon request.
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cold and Heat Investigation to Lower Levels of Depression
- ClinicalTrials.gov ID
- NCT06263738
- Acronym / sponsor ID
- CHILL'D / 20244106
- Conditions
- Depression, Mood Disorders, Healthy (Controls)
- Keywords
- Depression, Mood Disorders, Mental Health, Integrative Health, Hyperthermia, Sauna, Cold Plunge
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 162 participants (estimated)
- Lead sponsor
- Barry SandlerUniversity, hospital or other
- Collaborators
- Steadman Philippon Research Institute
- Study start
- 14 May 2024 (actual)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 16 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
- 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).
| Arm | Type | Receives |
|---|---|---|
| Depression + Whole Body Hyperthermia | Active comparator | Procedure: Whole Body HyperthermiaParticipants experiencing depression will receive a single heat treatment using the Clearlight Sauna Dome lasting up to 140 minutes. |
| Depression + Whole Body Hyperthermia + Cold Water Plunge | Active comparator | Procedure: Whole Body Hyperthermia, Procedure: Cold Water PlungeParticipants experiencing depression 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. |
| No Depression + Whole Body Hyperthermia | Active comparator | Procedure: Whole Body HyperthermiaParticipants not experiencing depression will receive a single heat treatment using the Clearlight Sauna Dome lasting up to 140 minutes. |
| No Depression + Whole Body Hyperthermia + Cold Water Plunge | Active comparator | Procedure: Whole Body Hyperthermia, Procedure: Cold Water PlungeParticipants not experiencing depression 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whole Body HyperthermiaAlso: Infrared Sauna, Whole Body HeatingParticipants in the heat exposure alone group will receive a single heat session using the Clearlight Sauna Dome lasting up to 140 minutes | Procedure or surgery | Depression + Whole Body Hyperthermia, Depression + Whole Body Hyperthermia + Cold Water Plunge, No Depression + Whole Body Hyperthermia, No Depression + Whole Body Hyperthermia + Cold Water Plunge |
| Cold Water PlungeAlso: Cold Plunge, Cold Water ExposureParticipants 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. | Procedure or surgery | Depression + Whole Body Hyperthermia + Cold Water Plunge, No Depression + Whole Body Hyperthermia + Cold Water Plunge |
Primary outcome
Montgomery-Åsberg Depression Rating Scale (MADRS)
Time frame: Baseline/Treatment (Visit 1), 1 Week Post-Treatment (Visit 2), 2 Weeks Post-Treatment (Visit 3)
The MADRS is a validated 10-item questionnaire to assess depression severity and is commonly used to assess efficacy of an intervention in clinical trials. Each item of the MADRS is measured on a scale of 0 to 6 (for a total score of 0 to 60) with higher scores indicating more severe depression. The MADRS includes questions on the following symptoms: 1. Reported sadness; 2. Apparent sadness; 3. Inner tension; 4. Reduced sleep; 5. Reduced appetite; 6. Concentration difficulties; 7. Lassitude; 8. Inability to feel; 9. Pessimistic thoughts; 10. Suicidal thoughts. Items are scored via a clinical interview that progresses from more broadly phrased questions about symptoms to more detailed queries that allow a precise rating of severity.
4 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2025.
- Individual participant dataSharing planned: Yes. De-identified data including, but not limited to, demographics, questionnaires, and adverse events will be made available upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Barry Sandler, DO principal investigator
Vail Health Behavioral Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whole Body Hyperthermia and Cold Water Plunge in people with Depression and Mood Disorders, run by Barry Sandler at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Study Coordinator (970-855-7374, BHIC@vailhealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Montgomery-Åsberg Depression Rating Scale (MADRS) (time frame: Baseline/Treatment (Visit 1), 1 Week Post-Treatment (Visit 2), 2 Weeks Post-Treatment (Visit 3)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2025.