WITHME: Hot Water Immersion Therapy for Mental Health

Sponsor
Lakehead University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04793542
Collaborator
Northern Ontario School of Medicine (Other)
150
1
3
24
6.3

Study Details

Study Description

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
  • Procedure: lower-limb hot water immersion
N/A

Study Design

Study Type:
Interventional
Anticipated 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
Anticipated Study Start Date :
Mar 15, 2021
Anticipated Primary Completion Date :
Dec 15, 2022
Anticipated Study Completion Date :
Mar 15, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Change in Patient Health Questionnaire - 9 Item [Change from baseline at 8 weeks]

    Self-report measure of depression severity

  2. Change in General Anxiety Disorder - 7 Item [Change from baseline at 8 weeks]

    Self-report measure of anxiety severity

  3. Change in Post-Traumatic Stress Disorder Checklist - 20 Item [Change from baseline at 8 weeks]

    Self-report measure that assesses symptoms of PTSD

Secondary Outcome Measures

  1. Post-water immersion thermal sensation [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 [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 [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'

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Lakehead University Thunder Bay Ontario Canada P7B 5E1

Sponsors and Collaborators

  • Lakehead University
  • Northern Ontario School of Medicine

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Nicholas Ravanelli, Assistant Professor, Lakehead University
ClinicalTrials.gov Identifier:
NCT04793542
Other Study ID Numbers:
  • 1468218
First Posted:
Mar 11, 2021
Last Update Posted:
Mar 11, 2021
Last Verified:
Mar 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 11, 2021