Hot Water Immersion Therapy for Mental Health

Study Overview
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Brief Summary
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In 2016, it was estimated that nearly 1 billion people worldwide were affected by a mental or addictive disorder, and were associated with considerable excess mortality. Acute heat therapy sessions (e.g. whole-body heating or foot immersions) have been shown to improve symptoms in individuals diagnosed with common mental health illness such as major depressive disorders and reduce anxiety. This study will assess the impact of an at-home 8-week lower-limb immersion in hot water on symptom severity in patients diagnosed with major depressive disorder, generalized anxiety disorder, and PTSD.

Official Title
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Evaluating Whether Lower-limb Hot Water Immersion Therapy Can Improve Symptoms in Individuals Diagnosed With Depression, Anxiety, and Post-traumatic Stress Disorders

Conditions
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Anxiety Disorders, Depression, Post-traumatic Stress Disorder, Heat, Water Immersion

Intervention / Treatment
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* Procedure: lower-limb hot water immersion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Over 18 years of age Diagnosed with depression, anxiety, or post-traumatic stress disorder Internet access (e.g. via smartphone, computer) Currently engaging in mental health treatment Exclusion Criteria: Free of any mental health disorder Not engaging in regular mental health treatment Diagnosed with other psychiatric disorders (e.g. schizophrenia, bipolar disorder, panic disorder)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br> | |
| Sham Comparator: Lukewarm Water<br> | Procedure: lower-limb hot water immersion<br>* For a minimum of 30 minutes, 3 times a week for 8 consecutive weeks, participants will submerge their lower-limbs into 30-32°C (lukewarm) or 39-40°C (hot) water which will be measured with a supplied waterproof thermometer.<br>|
| Active Comparator: Hot Water<br> | Procedure: lower-limb hot water immersion<br>* For a minimum of 30 minutes, 3 times a week for 8 consecutive weeks, participants will submerge their lower-limbs into 30-32°C (lukewarm) or 39-40°C (hot) water which will be measured with a supplied waterproof thermometer.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Patient Health Questionnaire - 9 Item | Self-report measure of depression severity | Change from baseline at 8 weeks | 
| Change in General Anxiety Disorder - 7 Item | Self-report measure of anxiety severity | Change from baseline at 8 weeks | 
| Change in Post-Traumatic Stress Disorder Checklist - 20 Item | Self-report measure that assesses symptoms of PTSD | Change from baseline at 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-water immersion thermal sensation | 7-point scale to assess one's thermal state, with -3 defined as Cold and 3 defined as Hot | throughout study completion, 8 weeks in duration | 
| Post-water immersion thermal comfort | 6-point scale to assess one's thermal satisfaction, with 1 and 6 defined as very comfortable and very uncomfortable, respectively. | throughout study completion, 8 weeks in duration | 
| Post-water immersion thermal preference | 5-point scale assessing whether the water temperature would be changed by the participant, with 2 defining 'much cooler' and -2 defining 'much warmer' | throughout study completion, 8 weeks in duration |