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| Name | Class |
|---|---|
| Northern Ontario School of Medicine | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | ||
| Lukewarm Water | Sham Comparator |
| |
| Hot Water | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lower-limb hot water immersion | Procedure | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nicholas Ravanelli, PhD | Contact | 1 (807) 343-8544 | nravanel@lakeheadu.ca |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lakehead University | Recruiting | Thunder Bay | Ontario | P7B 5E1 | Canada |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D003863 | Depression |
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D040921 | Stress Disorders, Traumatic |
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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 |
| D000068099 |
| Trauma and Stressor Related Disorders |