Note: This study is currently only recruiting patients in the hospital.

If you are interested in being notified if this study begins recruiting from the general population, please use the 'I Am Interested' button below.

Looking for alternative treatments for your depression? Try Whole-Body Hyperthermia!

Research suggests that Whole Body Hyperthermia in a sauna-like environment can reduce depressive symptoms. We aim to study the mechanisms underlying this response and the feasibility of this procedure for patients experiencing depression

Massachusetts General Hospital Depression Mood Disorders Mental Health
12 hours over 6 visits
Estimated Time Commitment
Male, Female, 18-65 years
May Be Eligible
Payment up to $400
May Be Offered
Survey, Personal health tracking, Blood draw, Office visit
May Be Required
 
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This project is not recruiting.

Overview

What we are studying

Past research has suggested that Whole Body Hyperthermia in a sauna-like environment can reduce depressive symptoms. The current study aims to understand the mechanisms underlying this response and examine the feasibility of this procedure as an alternative treatment for depression. In this study, we will collect blood samples and behavioral measures (e.g., surveys) in order to understand how a single treatment of WBH influences inflammation and depressive symptoms. 


Why it is important

Depression is the third leading cause of overall global disease burden. Up to one-third of individuals diagnosed with depression do not adequately respond to existing treatments for their symptoms, so there is a need for new therapies. By studying the mechanism and effects of Whole Body Hyperthermia, we hope to optimize its effectiveness as a treatment for depression.


What we hope to accomplish

Principal Investigator

Simmie Foster, MD, PhD

Massachusetts General Hospital

Public Profile

Who can participate

You may be eligible to participate in our study if you:


1. Are between the ages of 18 and 65


2. Currently feeling depressed


* all potential subjects will be evaluated by the study doctor in order to determine eligibility

Who cannot participate

Participants will be deemed ineligible to participate if they have any of the following conditions:



  1. Pregnancy or planned pregnancy during study

  2. Current breastfeeding 

  3. History of psychiatric hospitalization within the past year 

  4. Active suicidal intent (“yes” on item 4 or 5 on the Columbia-Suicide Severity Rating Scale)

  5. History of bipolar disorder, psychotic disorders, active eating disorders, and/or substance abuse or dependence (within the last year), as per the Mini-International Neuropsychiatric Interview (MINI) 

  6. Meeting DSM-5 criteria at screening for current primary obsessive compulsive disorder
    A ≥25% drop in IDS-CR score from screen (V1) to baseline (V1b)

  7. Positive urine toxicology screen due to illicit drug use or other exclusionary medications. (Potential false positives will be addressed on a case-by-case basis at the discretion of the investigator)

  8. Serious unstable medical condition including cardiovascular, neurological, neoplastic,  autoimmune,  infectious  or  endocrine.  

  9. Morbid obesity (BMI > 40) and/or body shape that might increase the risk of cutaneous burning from the Heckel HT3000 hyperthermia device (because of truncal skin being too close to the infrared lights). 

  10. Any history of or current diagnosis of thrombosis; if it is unclear whether a subject has received this diagnosis, a signed release will be obtained to contact the subject's treating physician and obtain accurate diagnostic information. Depending on the recommendation of the treating physician, the subject may undergo appropriate testing with the treating physician to verify the diagnosis, and if the tests produce negative findings, the subject may be allowed to enter the study

  11. Has a history of or an increased risk for gastrointestinal perforation such as a history of diverticulitis, stomach or intestinal ulcers or abdominal pain that does not go away

  12. Using medication that might impact thermoregulatory capacity and cannot be held for an appropriate length (at least one half-life) as determined by clinician judgment prior to receiving  WBH  treatment, including: diuretics,  barbiturates,  beta-blockers,  antipsychotic agents, anti-cholinergic agents or chronic use of antihistamines, aspirin (other than low-dose ASA for prophylactic purposes), non-steroidal anti-inflammatory drugs (NSAIDs), systemic corticosteroids, or cytokine antagonists.

  13. Use of any medication that could interact in such a way as to potentiate the sedative effect of lorazepam or ondansetron, or otherwise deemed unsafe per physician judgment.

  14.  

  15. Fever (Temp > 99) of unknown origin at the time of screen

  16. Breast Implants 

  17. Unsafe cardiac status as defined by abnormal ECG reading at screening visit as determined by medical monitor, study doctor, or subject’s PCP or cardiologist

  18. Claustrophobia of sufficient severity to interfere with ability to enter/remain in Heckel HT3000 device

  19. A subject who in the opinion of the Principal Investigator would not be able to safely complete the study or would jeopardize study integrity

What you may be asked to do

Participants in this study will be asked to come in for four in-person visits: a screening visit to confirm eligibility, an intervention visit where they will receive either Whole Body Hyperthermia or a sham treatment, a 24 hour followup visit, and a 1-week followup visit. At each visit, they will complete a series of clinician-administered and self-administered questionnaires about their physical and mental health, and blood will be drawn from their arm. On the day of the intervention, participants will either receive Whole Body Hyperthermia, a heating procedure that raises their body temperature over the course of ~2 hours, or a sham treatment. 


After the last in-person visit, participants will be asked to complete two fully remote followup visits (2 weeks and 4 weeks after their intervention visit), where a clinician will assess them via phone/videoconferencing and they will complete surveys on a computer. 


During the first half of the study, participants are also invited to use a wearable device called the Oura Ring, which passively collects physiological data (e.g., sleep and activity tracking). The device looks and feels like a normal ring that you wear on your finger, and syncs with an app on your smartphone. The use of the Oura Ring is not required to participate in the study, but will be offered to all participants. Participants must return the ring at their last in-person visit. 


Project activities may include:

  • Survey
  • Personal health tracking
  • Blood draw
  • Office visit

Estimated Time Commitment

12 hours over 6 visits

What You May Get

Participants will be compensated up to $400 for completing all 6 visits (a screening visit, an intervention visit, two in-person followup visits, and two fully remote followup visits). If participants terminate their study involvement early, they will only be compensated for the visits they completed.  

Location

Depression Clinical & Research Program
1 Bowdoin Sq, 6th Floor, Boston, MA, 02114

Map it!


Travel

  • Parking available
  • Parking reimbursed
  • Accessible by public transportation
  • Local travel reimbursed

Travel and Parking Details

Directions to MGH Depression and Clinical Research Program One Bowdoin Square, 6th Floor


Our Center is located on the 6th floor of the pink granite, high-rise building called One Bowdoin Square, which sets back from a small public park at the intersection of Cambridge and New Chardon Streets, directly across the street from Rite-Aid Pharmacy.


Driving/Parking, MGH: We can only validate parking at the MGH garages – Parkman, Fruit or Yawkey. If you choose to park in public parking garages, you do so at your own cost. We will not reimburse you for parking outside of MGH. We are approximately a 12 minute walk from the MGH garages or you can utilize the free hospital shuttle service.


 


Public Transportation: 



  • One Bowdoin Square building is one building down (same side of Cambridge Street) from the Bowdoin MBTA station, last stop on the Blue Line, behind the public park.

  • Green Line to Government Center: Walk down Cambridge Street towards MGH. One Bowdoin Square building is located at the intersection of Cambridge and New Chardon Streets behind the public park.

  • Orange Line, Haymarket: Walk up New Sudbury Street towards Beacon Hill and then make a right and proceed on Cambridge Street. One Bowdoin Square is located on the right at the intersection of Cambridge and New Chardon Streets behind the public park.

  • Red Line, Charles/MGH: Walk twelve minutes up Cambridge Street towards Government Center. One Bowdoin Square is located on the left at the intersection of Cambridge and New Chardon Streets behind the public park. If you cannot walk, ask at the Yawkey Information Desk to request campus shuttle van to bring you to 25 New Chardon Street.

  • Commuter Rail to North Station: Walk up Staniford Street to Cambridge Street; take a left toward New Chardon Street. One Bowdoin Square is located at the intersection of Cambridge and New Chardon Streets. You can also take the free Partners bus from North Station to the Staniford Street stop, walk one block to Cambridge Street, take a left and walk one block to New Chardon and Cambridge Street intersection. One Bowdoin Square is behind the public park.

  • Commuter Rail to South Station:Take the Red line to the Charles/MGH Stop. See Red Line to Charles/MGH directions above. 

Additional Information

Project Website

depressionmgh.org


ClinicalTrials.gov Identifier

NCT05366270


Study Phase

Phase 2: This project studies whether a medication or treatment works for people with a specific disease or condition. The drug or treatment has been studied for safety in healthy volunteers, but the project will continue to look at safety and short term side effects.


Participating Institutions


Funding Source

  • NIH or Other Federal
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