Anxiety DisordersWITHMENCT04793542
Hot Water Immersion Therapy for Mental Health
A study testing lower-limb hot water immersion in people with Anxiety Disorders and Depression, run by Lakehead University at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety Disorders, Depression, Post-traumatic Stress Disorder
- What is being tested?
- lower-limb hot water immersion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteCanada
- Study dates
- 15 Mar 2021to 15 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Lakehead University
Thunder Bay, Ontario, P7B 5E1
Nicholas Ravanelli, PhD, 1 (807) 343-8544, nravanel@lakeheadu.ca
Diane Whitney, Dr.
About this study
Official title: Evaluating Whether Lower-limb Hot Water Immersion Therapy Can Improve Symptoms in Individuals Diagnosed With Depression, Anxiety, and Post-traumatic Stress Disorders
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.
- Being tested
- lower-limb hot water immersion
- Medical subject headings
- Anxiety Disorders, Depression, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lower-limb hot water immersionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Not described |
| Lukewarm Water | Sham comparator | Not described Receives: Procedure: lower-limb hot water immersion |
| Hot Water | Active comparator | Not described Receives: Procedure: lower-limb hot water immersion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Patient Health Questionnaire - 9 Item
Self-report measure of depression severity
Measured: Change from baseline at 8 weeks
Change in General Anxiety Disorder - 7 Item
Self-report measure of anxiety severity
Measured: Change from baseline at 8 weeks
Change in Post-Traumatic Stress Disorder Checklist - 20 Item
Self-report measure that assesses symptoms of PTSD
Measured: Change from baseline at 8 weeks
Secondary outcomes (3)
Post-water immersion thermal sensation
7-point scale to assess one's thermal state, with -3 defined as "Cold" and 3 defined as "Hot"
Measured: throughout study completion, 8 weeks in duration
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.
Measured: 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'
Measured: throughout study completion, 8 weeks in duration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2021
- Study start15 Mar 2021 (estimated)
- Primary completion15 Dec 2022 (estimated)
- Study completion15 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lakehead University
- Sponsor type
- University, hospital or other
- Collaborators
- Northern Ontario School of Medicine
- Responsible party
- Principal investigator, Nicholas Ravanelli, Lakehead University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04793542
- Sponsor's protocol ID
- 1468218
- Acronym
- WITHME
- Status last verified
- Mar 2021
- First submitted
- 4 Mar 2021
- Last updated
- 11 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Whether Lower-limb Hot Water Immersion Therapy Can Improve Symptoms in Individuals Diagnosed With Depression, Anxiety, and Post-traumatic Stress Disorders
- ClinicalTrials.gov ID
- NCT04793542
- Acronym / sponsor ID
- WITHME / 1468218
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Lakehead UniversityUniversity, hospital or other
- Collaborators
- Northern Ontario School of Medicine
- Study start
- 15 Mar 2021 (estimated)
- Primary completion
- 15 Dec 2022 (estimated)
- Study completion
- 15 Mar 2023 (estimated)
- First posted
- 11 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | – |
| Lukewarm Water | Sham comparator | Procedure: lower-limb hot water immersion |
| Hot Water | Active comparator | Procedure: lower-limb hot water immersion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lower-limb hot water immersionFor 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. | Procedure or surgery | Hot Water, Lukewarm Water |
Primary outcome
Change in Patient Health Questionnaire - 9 Item
Time frame: Change from baseline at 8 weeks
Self-report measure of depression severity
Change in General Anxiety Disorder - 7 Item
Time frame: Change from baseline at 8 weeks
Self-report measure of anxiety severity
Change in Post-Traumatic Stress Disorder Checklist - 20 Item
Time frame: Change from baseline at 8 weeks
Self-report measure that assesses symptoms of PTSD
3 secondary outcomes
Post-water immersion thermal sensation
Time frame: throughout study completion, 8 weeks in duration
Post-water immersion thermal comfort
Time frame: throughout study completion, 8 weeks in duration
Post-water immersion thermal preference
Time frame: throughout study completion, 8 weeks in duration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lower-limb hot water immersion in people with Anxiety Disorders and Depression, run by Lakehead University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nicholas Ravanelli, PhD (1 (807) 343-8544, nravanel@lakeheadu.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Patient Health Questionnaire - 9 Item (time frame: Change from baseline at 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2021.