Hot Water Immersion Therapy for Mental Health

Depression Clinical Trial

— WITHME  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04793542
• Other study ID #: 1468218
• Status: Recruiting
• Phase: N/A
• Start date: March 15, 2021
• Est. completion date: March 15, 2023

Study information

• Verified date: March 2021
• Source: Lakehead University
• Contact: Nicholas Ravanelli, PhD
• Phone: 1 (807) 343-8544
• Email: nravanel[@]lakeheadu.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: March 15, 2023
• Est. primary completion date: December 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Anxiety Disorders
• Depression
• Disease
• Heat
• Post-traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic
• Water Immersion

Intervention

Procedure:
• lower-limb hot water immersion
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.

Locations

Country	Name	City	State
Canada	Lakehead University	Thunder Bay	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Lakehead University	Northern Ontario School of Medicine

Country where clinical trial is conducted

Canada, 

Outcome

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