DepressionNCT02174003
Whole Body Hyperthermia Registry Study
An observational study of Depression and Anxiety, run by University of Arizona at 1 site in United States.
Trial summary
This protocol will allow for the implementation of a research registry pertaining to Whole Body Hyperthermia (WBH) use in various subject populations. The primary objective of the proposed study is to determine if WBH can have beneficial effects in various subject populations currently experiencing numerous other… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depression, Anxiety, PTSD
- What is being tested?
- High intensity whole-body infrared heating
- Type of treatment
- Medical device
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to Aug 2016
- How long will I take part?
- 1 Week
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: For the purposes of this study we will enroll subjects 18 years and older to undergo a Hyperthermia session in an open fashion. We expect approximately 20-30 subjects per year to undergo this open hyperthermia treatment. Subjects must be medically healthy enough to be able to undergo the Hyperthermia session, all exclusion criteria listed below address what is deemed "medically healthy". Inclusion into this study will require that the minimum safety standards described in the eligibility criteria, there will be no inclusion of children, pregnant women, mentally impaired individuals, or prisoners in this registry. Subjects who appear to have Major Depressive Disorder will be referred to Protocol 12-0147-01 due to the specific aims pertaining directly to depressive symptoms.
Who may be able to join
- Male or female outpatients aged 18+.
- Able to understand the nature of the study and able to provide written informed consent prior to conduct of any study procedures.
- Able to communicate in English or Spanish with study personnel.
Who cannot join
- If patient has a medical condition or disorder that:
- Is unstable and clinically significant, or:
- Could, in the investigator's opinion, interfere with the accurate assessment of safety or efficacy of the procedure, including:
- Individuals who are using prescription drugs that may impair thermoregulatory cooling,
- Individuals with cardiovascular conditions or problems (uncontrolled hypertension, congestive heart failure, or documented evidence of coronary artery disease)
- Individuals with chronic conditions/diseases associated with a reduced ability initiate thermoregulatory cooling, including Parkinson's, multiple sclerosis, central nervous system tumors, and diabetes with neuropathy,
Show all 14Show fewer
- Individuals with a fever the day of study intervention (if so, they will be rescheduled),
- Individuals with hypersensitivity to heat,
- Individuals with enclosed infections, be they dental, in joints, or in any other tissues,
- Women who are pregnant Obesity and overall size of subject.
- It will be up to the PI's discretion will consider BMI, waist circumference, and body fat composition when determining eligibility and safety of the individual.
- History of peripheral circulatory disease, for example peripheral vascular disease, deep vein thrombosis (DVT), or lymphedema.
- History of stroke, epilepsy or cerebral aneurisms
- Diabetes mellitus types I or II.
Trial locations and contacts
1 site in 1 country.
About this study
This protocol will allow for the implementation of a research registry pertaining to Whole Body Hyperthermia (WBH) use in various subject populations. The primary objective of the proposed study is to determine if WBH can have beneficial effects in various subject populations currently experiencing numerous other comorbidities, and the duration of the effect(s).
This protocol is intended to become a secondary resort for individual's interested in receiving a Hyperthermia treatment for potential beneficial gain related to symptoms stemming from comorbidities other than depression (i.e. Fibromyalgia, Perimenopausal symptoms, arthritis, etc). Due to the fact that no external research funding has been acquired for this broad application this protocol is intended to charge a fee for cost covering purposes only.
The registry trial will not be limited to only include individuals with major depressive disorder, however, this protocol will allow for an expanded use in all populations (while still excluding subjects based on safety parameters). We will monitor subject's physiological and clinical outcomes (if applicable) from a single Whole Body Hyperthermia treatment in an open fashion (no placebo/control condition). This registry study will include safety assessments 5 days prior to WBH, the day of WBH and 1 week following WBH.
Read the detailed description
The WBH procedure proposed in this protocol has been rigorously researched in subjects with Major Depressive Disorder (MDD), and there are little to no preliminary data pertaining to WBH use in populations outside of depression studies. In preliminary studies in Europe and a rigorously tested clinical trial being conducted at the University of Arizona (NCT01625546), a single exposure to WBH resulted in a decrease in depressive symptoms as measured using the German version of the CES-D depression scale 5 days later (in the study in Switzerland) and using the HamD rating scale 7 days later in the UA study. All research applications thus far have resulted in minimal adverse effects to study subjects.
During the conduct of research protocol 12-0147-04/NCT01625546 (WBH in subjects with Major Depression) our research site has been contacted by numerous individuals across the country asking if they can participate in our clinical trial. However due to the rigorous inclusion/exclusion criteria necessary for data collection, these individuals cannot be offered the research treatment. This protocol is intended to become a secondary resort for these individual's interested in receiving a Hyperthermia treatment for potential beneficial gain related to symptoms stemming from other comorbidities (i.e. Fibromyalgia, Perimenopausal symptoms, arthritis, etc). In fact, over the course of this study, several individuals who suffer from fibromyalgia, rheumatoid arthritis and other similar afflictions have, in discussions with study staff at screening, indicated that they have previously researched infrared heating and whole body hyperthermia and found that it was helpful to many people with these afflictions. As such, they are interested in being a part of the study in order to receive treatment that might help ease their pain from these afflictions in addition to the depression symptoms they are experiencing, given that depression is often a co-morbidity of these illnesses. Due to the fact that no external research funding has been acquired for this broad application, this protocol intended to charge a fee for cost covering purposes only.
The registry trial will not be limited to only include individuals with MDD, however this protocol will allow for an expanded use in all populations (while still excluding subjects based on safety parameters). We will monitor subject's physiological and clinical outcomes (if applicable) from a single Whole Body Hyperthermia treatment in an open fashion (no placebo/control condition). This registry study will include safety assessments 5 days prior to WBH, the day of WBH and 1 week following WBH.
Costs for Participating in the Study:
The WBH session is an investigational procedure, one approved for limited testing by the Food and Drug Administration (FDA) but not in general use. In addition to your time, you will be charged a fee of $800 for cost covering purposes only. The cost for this open treatment hyperthermia session will cover departmental staff time, clinical space, research materials, and overhead fees. You may pay with cash, check, or credit card. If you wish to pay with a credit card, a 3% fee will be assessed to cover credit card processing fees. All payments will be made to the Department of Psychiatry and will be processed by our Departmental business office.
The payment may be broken into 2 tiers:
Screening: $200 WBH Procedure: $600 If you qualify for WBH procedure the remaining $600 will be due prior to completion of the procedure.
If you pay in full and it is determined you do not qualify for the study, you will be reimbursed less any amount needed to cover procedures performed (i.e. screening).
Future WBH Treatment Sessions:
If you wish to undergo another WBH procedure, you may do so without have to repeat screening bloods and EKG's within 1 year of the original screen, so long as you report no significant changes in your health history to the study staff. You will not be charged for screening procedures for subsequent WBH procedures. Those individuals who have participated in previous WBH protocols will be considered eligible without need for a re-screen within 1 year of their original screening procedures.
- Conditions
- Depression, Anxiety, PTSD, Fibromyalgia, Chronic Fatigue Syndrome
- Being tested
- High intensity whole-body infrared heating
- Keywords
- whole body hyperthermia, depression, fibromyalgia, rheumatoid arthritis, perimenopausal symptoms, open treatment
- Medical subject headings
- Depression, Anxiety Disorders, Stress Disorders, Post-Traumatic, Fibromyalgia, Fatigue Syndrome, Chronic, Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High intensity whole-body infrared heatingDevice
Also called WBH
The Whole Body Hyperthermia system uses water-filtered infrared-A (wIRA) heat radiation. The rise in the body's core temperature is correspondingly rapid and well-tolerated. There are two phases of the thermal challenge, 1) Irradiation phase during which the patient lies recumbent with his/her head positioned outside the tent. The wIRA irradiators are arranged above the exposed upper part of the body; and 2) Heat retention phase during which the patient lies in the chamber with the walls of the tent positioned to retain heat. Core body temperatures will be raised to those comparable to a mild fever 37.8-38.5°C.
| Study group | Role | What they receive |
|---|---|---|
| Open Treatment Group | The Open Treatment Group (all participants in this study) will receive the active / WBH treatment in an open fashion. Receives: Device: High intensity whole-body infrared heating |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in depression scores over time [Inventory of Depressive Symptomatology-Self Report (IDS-SR)]
Percent change in scores between baseline and subsequent assessments will be assessed
Measured: Screening, WBH treatment day and 1 week following treatment.
Secondary outcomes (4)
Change in Positive and Negative Affect
Percent change in positive and negative affect will be assessed between baseline and subsequent assessments using the Positive and Negative Affect Schedule (PANAS)
Measured: Screening, WBH treatment and 1 week following WBH treatment
Change in Morning / Evening Questionnaire
Percent change in morning versus evening behavioral preferences will be assessed between baseline and subsequent assessments using the Morningness and Eveningness Questionnaire (MEQ).
Measured: Screening, WBH Treatment day, 1 week following WBH Treatment
Change in Quality of Life
Percent change in scores using the Quality of Life Enjoyment and Satisfaction (Q-LESQ-SF) questionnaire.
Measured: Screening, WBH Treatment Day and 1 week following WBH treatment
Change in functional impairment
Percent change in score on the Sheehan Disability Scale to assess improvements in work/school, social and family life.
Measured: Screening, WBH Treatment Day and 1 week following WBH treatment day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionAug 2016
- Study completionAug 2016
Why it stopped: Investigator transferred to the University of Wisconsin - Madison
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 2 participants (actual)
- Target duration
- 1 Week
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Charles Raison, MD, Principal investigator, University of Arizona, Department of Psychiatry, College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02174003
- Sponsor's protocol ID
- 1406365027
- Status last verified
- Jul 2015
- First submitted
- 23 Jun 2014
- Last updated
- 31 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Whole Body Hyperthermia Registry Study
- ClinicalTrials.gov ID
- NCT02174003
- Acronym / sponsor ID
- 1406365027
- Conditions
- Depression, Anxiety, PTSD, Fibromyalgia, Chronic Fatigue Syndrome
- Keywords
- whole body hyperthermia, depression, fibromyalgia, rheumatoid arthritis, perimenopausal symptoms, open treatment
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Investigator transferred to the University of Wisconsin - Madison
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 25 Jun 2014 (estimated)
- 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.
This protocol will allow for the implementation of a research registry pertaining to Whole Body Hyperthermia (WBH) use in various subject populations. The primary objective of the proposed study is to determine if WBH can have beneficial effects in various subject populations currently experiencing numerous other comorbidities, and the duration of the effect(s).
This protocol is intended to become a secondary resort for individual's interested in receiving a Hyperthermia treatment for potential beneficial gain related to symptoms stemming from comorbidities other than depression (i.e. Fibromyalgia, Perimenopausal symptoms, arthritis, etc). Due to the fact that no external research funding has been acquired for this broad application this protocol is intended to charge a fee for cost covering purposes only.
The registry trial will not be limited to only include individuals with major depressive disorder, however, this protocol will allow for an expanded use in all populations (while still excluding subjects based on safety parameters). We will monitor subject's physiological and clinical outcomes (if applicable) from a single Whole Body Hyperthermia treatment in an open fashion (no placebo/control condition). This registry study will include safety assessments 5 days prior to WBH, the day of WBH and 1 week following WBH.
Detailed description
The WBH procedure proposed in this protocol has been rigorously researched in subjects with Major Depressive Disorder (MDD), and there are little to no preliminary data pertaining to WBH use in populations outside of depression studies. In preliminary studies in Europe and a rigorously tested clinical trial being conducted at the University of Arizona (NCT01625546), a single exposure to WBH resulted in a decrease in depressive symptoms as measured using the German version of the CES-D depression scale 5 days later (in the study in Switzerland) and using the HamD rating scale 7 days later in the UA study. All research applications thus far have resulted in minimal adverse effects to study subjects.
During the conduct of research protocol 12-0147-04/NCT01625546 (WBH in subjects with Major Depression) our research site has been contacted by numerous individuals across the country asking if they can participate in our clinical trial. However due to the rigorous inclusion/exclusion criteria necessary for data collection, these individuals cannot be offered the research treatment. This protocol is intended to become a secondary resort for these individual's interested in receiving a Hyperthermia treatment for potential beneficial gain related to symptoms stemming from other comorbidities (i.e. Fibromyalgia, Perimenopausal symptoms, arthritis, etc). In fact, over the course of this study, several individuals who suffer from fibromyalgia, rheumatoid arthritis and other similar afflictions have, in discussions with study staff at screening, indicated that they have previously researched infrared heating and whole body hyperthermia and found that it was helpful to many people with these afflictions. As such, they are interested in being a part of the study in order to receive treatment that might help ease their pain from these afflictions in addition to the depression symptoms they are experiencing, given that depression is often a co-morbidity of these illnesses. Due to the fact that no external research funding has been acquired for this broad application, this protocol intended to charge a fee for cost covering purposes only.
The registry trial will not be limited to only include individuals with MDD, however this protocol will allow for an expanded use in all populations (while still excluding subjects based on safety parameters). We will monitor subject's physiological and clinical outcomes (if applicable) from a single Whole Body Hyperthermia treatment in an open fashion (no placebo/control condition). This registry study will include safety assessments 5 days prior to WBH, the day of WBH and 1 week following WBH.
Costs for Participating in the Study:
The WBH session is an investigational procedure, one approved for limited testing by the Food and Drug Administration (FDA) but not in general use. In addition to your time, you will be charged a fee of $800 for cost covering purposes only. The cost for this open treatment hyperthermia session will cover departmental staff time, clinical space, research materials, and overhead fees. You may pay with cash, check, or credit card. If you wish to pay with a credit card, a 3% fee will be assessed to cover credit card processing fees. All payments will be made to the Department of Psychiatry and will be processed by our Departmental business office.
The payment may be broken into 2 tiers:
Screening: $200 WBH Procedure: $600 If you qualify for WBH procedure the remaining $600 will be due prior to completion of the procedure.
If you pay in full and it is determined you do not qualify for the study, you will be reimbursed less any amount needed to cover procedures performed (i.e. screening).
Future WBH Treatment Sessions:
If you wish to undergo another WBH procedure, you may do so without have to repeat screening bloods and EKG's within 1 year of the original screen, so long as you report no significant changes in your health history to the study staff. You will not be charged for screening procedures for subsequent WBH procedures. Those individuals who have participated in previous WBH protocols will be considered eligible without need for a re-screen within 1 year of their original screening procedures.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Week
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open Treatment Group | – | Device: High intensity whole-body infrared heatingThe Open Treatment Group (all participants in this study) will receive the active / WBH treatment in an open fashion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- For the purposes of this study we will enroll subjects 18 years and older to undergo a Hyperthermia session in an open fashion. We expect approximately 20-30 subjects per year to undergo this open hyperthermia treatment. Subjects must be medically healthy enough to be able to undergo the Hyperthermia session, all exclusion criteria listed below address what is deemed "medically healthy". Inclusion into this study will require that the minimum safety standards described in the eligibility criteria, there will be no inclusion of children, pregnant women, mentally impaired individuals, or prisoners in this registry. Subjects who appear to have Major Depressive Disorder will be referred to Protocol 12-0147-01 due to the specific aims pertaining directly to depressive symptoms.
Key inclusion criteria (3 listed)
- Male or female outpatients aged 18+.
- Able to understand the nature of the study and able to provide written informed consent prior to conduct of any study procedures.
- Able to communicate in English or Spanish with study personnel.
Key exclusion criteria (14 listed)
- If patient has a medical condition or disorder that:
- Individuals who are using prescription drugs that may impair thermoregulatory cooling,
- Individuals with cardiovascular conditions or problems (uncontrolled hypertension, congestive heart failure, or documented evidence of coronary artery disease)
- Individuals with chronic conditions/diseases associated with a reduced ability initiate thermoregulatory cooling, including Parkinson's, multiple sclerosis, central nervous system tumors, and diabetes with neuropathy,
- Individuals with a fever the day of study intervention (if so, they will be rescheduled),
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 |
|---|---|---|
| High intensity whole-body infrared heatingAlso: WBHThe Whole Body Hyperthermia system uses water-filtered infrared-A (wIRA) heat radiation. The rise in the body's core temperature is correspondingly rapid and well-tolerated. There are two phases of the thermal challenge, 1) Irradiation phase during which the patient lies recumbent with his/her head positioned outside the tent. The wIRA irradiators are arranged above the exposed upper part of the body; and 2) Heat retention phase during which the patient lies in the chamber with the walls of the tent positioned to retain heat. Core body temperatures will be raised to those comparable to a mild fever 37.8-38.5°C. | Device | Open Treatment Group |
Primary outcome
Change in depression scores over time [Inventory of Depressive Symptomatology-Self Report (IDS-SR)]
Time frame: Screening, WBH treatment day and 1 week following treatment.
Percent change in scores between baseline and subsequent assessments will be assessed
4 secondary outcomes
Change in Positive and Negative Affect
Time frame: Screening, WBH treatment and 1 week following WBH treatment
Change in Morning / Evening Questionnaire
Time frame: Screening, WBH Treatment day, 1 week following WBH Treatment
Change in Quality of Life
Time frame: Screening, WBH Treatment Day and 1 week following WBH treatment
Change in functional impairment
Time frame: Screening, WBH Treatment Day and 1 week following WBH treatment day
Results and safety
The study was stopped early (reason given: Investigator transferred to the University of Wisconsin - Madison). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2025.
Related trials for Depression
Not yet recruitingObservational study
Validation of Wearable Core Body Temperature-Based Circadian Rhythm Digital Biomarkers
Mood Disorders, Major Depressive Diorder
RecruitingObservational study
A Prospective Study of Anxiety, Depression, and Bipolar Disorder in People
Anxiety Disorders, Depressive Disorder
RecruitingPhase 3
A Study of Vortioxetine in Japanese Pediatric Patients With Major Depressive Disorder
Major Depressive Disorder
Recruiting
Anticipated Patient and Caregiver Burden
Amyotrophic Lateral Sclerosis
Recruiting
A Study of Brief Behavioral Activation for the Treatment of Depression in Older Adult Cancer Survivors
Survivorship
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.
Charles Raison, MD principal investigator
University of Arizona, Department of Psychiatry, College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depression and Anxiety, run by University of Arizona at 1 site in United States.
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 3 inclusion and 14 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: stopped early, as of the sponsor's last update on 31 Jul 2025. 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 United States. 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. 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?
The study was stopped early (reason given: Investigator transferred to the University of Wisconsin - Madison). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in depression scores over time [Inventory of Depressive Symptomatology-Self Report (IDS-SR)] (time frame: Screening, WBH treatment day and 1 week following treatment.). 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 31 Jul 2025.