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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04793542
Other study ID # 1468218
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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)

Study Design


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
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