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Hot Water Immersion Therapy for Mental Health (WITHME)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04793542
Recruitment Status : Recruiting
First Posted : March 11, 2021
Last Update Posted : March 11, 2021
Sponsor:
Collaborator:
Northern Ontario School of Medicine
Information provided by (Responsible Party):
Nicholas Ravanelli, Lakehead University

Brief 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.


Condition or disease Intervention/treatment Phase
Anxiety Disorders Depression Post-traumatic Stress Disorder Heat Water Immersion Procedure: lower-limb hot water immersion Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluating Whether Lower-limb Hot Water Immersion Therapy Can Improve Symptoms in Individuals Diagnosed With Depression, Anxiety, and Post-traumatic Stress Disorders
Estimated Study Start Date : March 15, 2021
Estimated Primary Completion Date : December 15, 2022
Estimated Study Completion Date : March 15, 2023

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Change in Patient Health Questionnaire - 9 Item [ Time Frame: Change from baseline at 8 weeks ]
    Self-report measure of depression severity

  2. Change in General Anxiety Disorder - 7 Item [ Time Frame: Change from baseline at 8 weeks ]
    Self-report measure of anxiety severity

  3. Change in Post-Traumatic Stress Disorder Checklist - 20 Item [ Time Frame: Change from baseline at 8 weeks ]
    Self-report measure that assesses symptoms of PTSD


Secondary Outcome Measures :
  1. Post-water immersion thermal sensation [ Time Frame: throughout study completion, 8 weeks in duration ]
    7-point scale to assess one's thermal state, with -3 defined as "Cold" and 3 defined as "Hot"

  2. Post-water immersion thermal comfort [ Time Frame: throughout study completion, 8 weeks in duration ]
    6-point scale to assess one's thermal satisfaction, with 1 and 6 defined as "very comfortable" and "very uncomfortable", respectively.

  3. Post-water immersion thermal preference [ Time Frame: throughout study completion, 8 weeks in duration ]
    5-point scale assessing whether the water temperature would be changed by the participant, with 2 defining 'much cooler' and -2 defining 'much warmer'



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04793542


Contacts
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Contact: Nicholas Ravanelli, PhD 1 (807) 343-8544 nravanel@lakeheadu.ca

Locations
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Canada, Ontario
Lakehead University Recruiting
Thunder Bay, Ontario, Canada, P7B 5E1
Contact: Nicholas Ravanelli, PhD    1 (807) 343-8544    nravanel@lakeheadu.ca   
Sub-Investigator: Diane Whitney, Dr.         
Sub-Investigator: Sarah Habinski, Dr.         
Sponsors and Collaborators
Lakehead University
Northern Ontario School of Medicine
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Responsible Party: Nicholas Ravanelli, Assistant Professor, Lakehead University
ClinicalTrials.gov Identifier: NCT04793542    
Other Study ID Numbers: 1468218
First Posted: March 11, 2021    Key Record Dates
Last Update Posted: March 11, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Disease
Depression
Anxiety Disorders
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Pathologic Processes
Behavioral Symptoms
Mental Disorders
Trauma and Stressor Related Disorders