Depression Clinical Trial
— WITHMEOfficial title:
Evaluating Whether Lower-limb Hot Water Immersion Therapy Can Improve Symptoms in Individuals Diagnosed With Depression, Anxiety, and Post-traumatic Stress Disorders
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 |
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.
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) |
Country | Name | City | State |
---|---|---|---|
Canada | Lakehead University | Thunder Bay | Ontario |
Lead Sponsor | Collaborator |
---|---|
Lakehead University | Northern Ontario School of Medicine |
Canada,
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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