Recruiting

Hot Water Immersion

Sponsor:

Lakehead University

Code:

NCT04793542

Conditions

Anxiety Disorders

Depression

Post-traumatic Stress Disorder

Heat

Water Immersion

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

lower-limb hot water immersion

Study Details

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.

Conditions

Anxiety Disorders

Depression

Post-traumatic Stress Disorder

Heat

Water Immersion

Study ID

NCT04793542

Start date

Mar 15, 2021

Status verified date

Mar, 2021

Completion date

Mar 15, 2023

Anticipated

Primary completion date

Dec 15, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

no intervention: Control

sham comparator: Lukewarm Water

active comparator: Hot Water

Interventions

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.

Primary outcome measure

  • Change in Patient Health Questionnaire - 9 Item [ Time Frame: Change from baseline at 8 weeks ]
  • Change in General Anxiety Disorder - 7 Item [ Time Frame: Change from baseline at 8 weeks ]
  • Change in Post-Traumatic Stress Disorder Checklist - 20 Item [ Time Frame: Change from baseline at 8 weeks ]

Central Contacts and Locations

Central contacts

Nicholas Ravanelli, PhD

1 (807) 343-8544nravanel@lakeheadu.ca

Locations

Lakehead University

Recruiting

Thunder Bay, Ontario, Canada, P7B 5E1

Contacts

Nicholas Ravanelli, PhD

1 (807) 343-8544nravanel@lakeheadu.ca

More Information

Sponsor

Lakehead University

Last update posted

Mar 11, 2021

Last verified

Mar, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Lakehead University on 2021-03-11.