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临床试验/NCT04793542
NCT04793542Unknown不适用

Evaluating Whether Lower-limb Hot Water Immersion Therapy Can Improve Symptoms in Individuals Diagnosed With Depression, Anxiety, and Post-traumatic Stress Disorders

Lakehead University2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2021年3月15日最近更新:
适应症

试验速览

阶段
不适用
入组人数
150
试验地点
2
主要终点
Change in General Anxiety Disorder - 7 Item

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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)

结局指标

主要结局

Change in General Anxiety Disorder - 7 Item

时间窗: Change from baseline at 8 weeks

Self-report measure of anxiety severity

Change in Post-Traumatic Stress Disorder Checklist - 20 Item

时间窗: Change from baseline at 8 weeks

Self-report measure that assesses symptoms of PTSD

Change in Patient Health Questionnaire - 9 Item

时间窗: Change from baseline at 8 weeks

Self-report measure of depression severity

次要结局

  • Post-water immersion thermal sensation(throughout study completion, 8 weeks in duration)
  • Post-water immersion thermal comfort(throughout study completion, 8 weeks in duration)
  • Post-water immersion thermal preference(throughout study completion, 8 weeks in duration)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nicholas Ravanelli

Assistant Professor

Lakehead University

研究点 (2)

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