Hot Water Immersion Therapy for Mental Health

NCT04793542 | Unknown

• 1 other identifier: 1468218
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (3)

• 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

Study Arms (3)

Control

NO INTERVENTION

Lukewarm Water

SHAM COMPARATOR

Procedure: lower-limb hot water immersion

Hot Water

ACTIVE COMPARATOR

Procedure: lower-limb hot water immersion

Interventions

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.

Hot Water; Lukewarm Water

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Lakehead University: lead
• Northern Ontario School of Medicine: collaborator

Study Sites (1)

Lakehead University

Thunder Bay, Ontario, P7B 5E1, Canada

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders; Depression; Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders

Central Study Contacts

Nicholas Ravanelli, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 4, 2021
• First Posted: March 11, 2021
• Study Start: March 15, 2021
• Primary Completion: December 15, 2022
• Study Completion: March 15, 2023
• Last Updated: March 11, 2021

Record last verified: 2021-03

Locations

CA (1)