Heat Therapy + Cold Water Plunge for Depression

(CHILL'D Trial)

Overseen By Study Coordinator

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Vail Health Behavioral Health

Must not be taking: Thermoregulatory medications

Disqualifiers: Pregnancy, Suicidal ideation, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 1 day

112 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial requires that you stop taking any medication that may affect your body's ability to regulate temperature.

What data supports the effectiveness of the treatment Heat Therapy + Cold Water Plunge for Depression?

Research suggests that whole-body hyperthermia (WBH), a component of heat therapy, shows promise as a treatment for depression, with studies indicating it can improve mood and reduce depressive symptoms. Additionally, hyperthermic baths, another form of heat therapy, have been found to have antidepressant effects when added to usual depression care. ^{1 2 3 4 5}

How does the Heat Therapy + Cold Water Plunge treatment for depression differ from other treatments?

This treatment combines whole-body hyperthermia (raising body temperature) and cold water plunges, which are non-drug approaches that may help improve mood by activating the body's stress response and increasing certain brain chemicals. Unlike traditional antidepressants, this method uses temperature changes to potentially relieve depressive symptoms without medication. ^{1 2 3 6 7}

Research Team

Barry Sandler, DO

Principal Investigator

Vail Health Behavioral Health

Eligibility Criteria

This trial is for medically healthy adults aged 18-65 who are currently experiencing symptoms of depression. Participants must be able to complete baseline assessments and follow-ups at 1 and 2 weeks after treatment.

Inclusion Criteria

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

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

I have been diagnosed with major depression lasting more than 60 days.

Exclusion Criteria

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.

I am taking medication that could affect my body's ability to regulate temperature.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either a single Whole Body Hyperthermia treatment or a Whole Body Hyperthermia treatment followed by a cold water plunge

1 day

1 visit (in-person)

Follow-up

Participants complete assessments of depressive symptoms at 1-week and 2-week post-treatment

2 weeks

2 visits (in-person)

Treatment Details

Interventions

• Cold Water Plunge
• Whole Body Hyperthermia

Trial Overview The study is testing the effects of heat therapy alone versus heat therapy followed by a cold water plunge on depressive symptoms. A total of 112 participants will be randomly assigned to one of these two treatments.

Participant Groups

Group I: Whole Body Hyperthermia Active Control 1 Intervention

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

Group II: Whole Body Hyperthermia + Cold Water Plunge Active Control 2 Interventions

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.

Whole Body Hyperthermia is already approved in European Union, United States, Switzerland for the following indications:

Approved in European Union as Whole Body Hyperthermia for:

• Depression
• Other conditions

Approved in United States as Whole Body Hyperthermia for:

• Major Depressive Disorder

Approved in Switzerland as Whole Body Hyperthermia for:

• Depression

Who Is Running the Clinical Trial?

Vail Health Behavioral Health

Lead Sponsor

Trials

1

Recruited

110+

Steadman Philippon Research Institute

Collaborator

Trials

11

Recruited

700+

Findings from Research

A single session of whole-body hyperthermia (WBH) using a commercially available infrared sauna successfully raised participants' core body temperature to 101.3°F, which is associated with reduced depressive symptoms in previous studies.

Participants reported significant reductions in self-reported negative affect and depression symptoms from one week before to one week after the WBH session, suggesting that this non-pharmacologic treatment may be effective for major depressive disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and acceptability of a Whole-Body hyperthermia (WBH) protocol. Mason, AE., Fisher, SM., Chowdhary, A., et al.[2022]

Whole-body hyperthermia (WBH) has shown promising effects on mood and depression symptoms, with 19 out of 21 study endpoints demonstrating significant effect sizes (Cohen's d of 0.8 or greater) across 7 studies involving 148 participants.

WBH interventions, which included hot baths and infrared heating, were generally safe with low risk of adverse reactions, but the evidence is still insufficient for broad clinical recommendations, highlighting the need for further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of whole-body hyperthermia interventions on mood and depression - are we ready for recommendations for clinical application? Hanusch, KU., Janssen, CW.[2019]

In a pilot study involving 45 outpatients with moderate depression, hyperthermic baths (HTB) showed a significant reduction in depression severity after 2 weeks, with a mean improvement of 4.3 points on the Hamilton Depression Rating Scale compared to a physical exercise program.

HTB was well-tolerated with no serious adverse events reported, making it a promising and accessible add-on treatment for depression, especially for individuals who may struggle with traditional exercise.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects and feasibility of hyperthermic baths in comparison to exercise as add-on treatment to usual care in depression: a randomised, controlled pilot study. Naumann, J., Kruza, I., Denkel, L., et al.[2021]

In a randomized, placebo-controlled pilot trial involving 36 adults with depressive disorder, hyperthermic baths (40 °C) significantly reduced depressive symptoms, showing a 3.14 point improvement on the Hamilton Scale for Depression after 4 weeks compared to a sham treatment.

The results suggest that hyperthermic baths could be an effective alternative treatment for depression, especially for patients who do not respond to conventional antidepressants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of hyperthermic baths on depression, sleep and heart rate variability in patients with depressive disorder: a randomized clinical pilot trial. Naumann, J., Grebe, J., Kaifel, S., et al.[2018]

A single session of whole-body hyperthermia (WBH) significantly reduced depressive symptoms compared to a sham treatment over a 6-week period, indicating its potential as an effective antidepressant intervention.

The study involved 30 participants with major depressive disorder, and the results showed that WBH was associated with sustained improvements in depression scores, with mild adverse events reported, suggesting it is a safe treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Whole-Body Hyperthermia for the Treatment of Major Depressive Disorder: A Randomized Clinical Trial. Janssen, CW., Lowry, CA., Mehl, MR., et al.[2017]

The hypothesis suggests that depression may arise from a lack of physiological stressors, like cold exposure, which could impair brain function, combined with genetic predispositions that exacerbate the condition.

Cold showers (20°C for 2-3 minutes) may activate the sympathetic nervous system and increase levels of mood-enhancing chemicals like beta-endorphin and noradrenaline, showing potential as a safe and effective treatment for depressive symptoms, though more rigorous studies are needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adapted cold shower as a potential treatment for depression. Shevchuk, NA.[2013]

An 8-week pilot study involving 28 medically healthy adults showed that heated (Bikram) yoga is feasible and acceptable as a treatment for depressive symptoms, with significant improvements in depression scores over time.

Participants who attended more classes experienced greater reductions in depressive symptoms, anxiety, and hopelessness, with over half of the participants showing a significant response to treatment by the end of the study.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Community-Delivered Heated Hatha Yoga as a Treatment for Depressive Symptoms: An Uncontrolled Pilot Study. Nyer, M., Hopkins, LB., Farabaugh, A., et al.[2021]

References

1. England pubmed.ncbi.nlm.nih.gov

Feasibility and acceptability of a Whole-Body hyperthermia (WBH) protocol. [2022]

2. England pubmed.ncbi.nlm.nih.gov

The impact of whole-body hyperthermia interventions on mood and depression - are we ready for recommendations for clinical application? [2019]

3. England pubmed.ncbi.nlm.nih.gov

Effects and feasibility of hyperthermic baths in comparison to exercise as add-on treatment to usual care in depression: a randomised, controlled pilot study. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Effects of hyperthermic baths on depression, sleep and heart rate variability in patients with depressive disorder: a randomized clinical pilot trial. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Whole-Body Hyperthermia for the Treatment of Major Depressive Disorder: A Randomized Clinical Trial. [2017]

6. United States pubmed.ncbi.nlm.nih.gov

Adapted cold shower as a potential treatment for depression. [2013]

7. United States pubmed.ncbi.nlm.nih.gov

Community-Delivered Heated Hatha Yoga as a Treatment for Depressive Symptoms: An Uncontrolled Pilot Study. [2021]