Hot Water Immersion Therapy for Mental Health (WITHME)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Depression; Anxiety Disorders; Post-traumatic Stress Disorder; Heat; Water Immersion
• Intervention / Treatment: Procedure: lower-limb hot water immersion

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nicholas Ravanelli, PhD; Phone Number: 1 (807) 343-8544; Email: nravanel@lakeheadu.ca

Study Locations

• Canada
  • Ontario
    • Thunder Bay, Ontario, Canada, P7B 5E1
      • Recruiting
      • Lakehead University
      • Contact: Nicholas Ravanelli, PhD; Phone Number: 1 (807) 343-8544; Email: nravanel@lakeheadu.ca
      • Sub-Investigator: Diane Whitney, Dr.
      • Sub-Investigator: Sarah Habinski, Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control
Sham Comparator: Lukewarm Water	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.
Active Comparator: Hot Water	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Lakehead University
• Collaborators: Northern Ontario School of Medicine

Study record dates

Study Major Dates

• Study Start (Anticipated): March 15, 2021
• Primary Completion (Anticipated): December 15, 2022
• Study Completion (Anticipated): March 15, 2023

Study Registration Dates

• First Submitted: March 4, 2021
• First Submitted That Met QC Criteria: March 8, 2021
• First Posted (Actual): March 11, 2021

Study Record Updates

• Last Update Posted (Actual): March 11, 2021
• Last Update Submitted That Met QC Criteria: March 8, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Pathologic Processes; Trauma and Stressor Related Disorders; Depression; Disease; Anxiety Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: 1468218

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No