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Search / Trial NCT07082998

Comparing the Efficacy of Heated Yoga and Sauna as a Treatment for Depression

Launched by MASSACHUSETTS GENERAL HOSPITAL · Jul 16, 2025

Trial Information

Current as of August 24, 2025

Not yet recruiting

Keywords

Depression Heated Yoga Yoga Sauna Mindfulness Mindfulness App Clinical Trial

ClinConnect Summary

This clinical trial is looking at whether heated yoga, sauna sessions, or using a mindfulness app can help reduce symptoms of depression in adults. The study aims to find out which of these methods might be effective as treatments for people experiencing moderate to severe depression. Participants will be adults between 18 and 65 years old who have a certain level of depressive symptoms, are able to use a smartphone for the mindfulness app, and can give informed consent to take part.

If you join the study, you can expect to participate in one or more of these activities—heated yoga classes, sauna sessions, or using a mindfulness app regularly—while keeping any current psychiatric treatments stable. The study excludes people who are pregnant, have recent serious mental health issues, certain medical conditions, or recent exposure to these activities. It’s important that participants are physically able to take part safely and have a doctor overseeing their care. This study has not started recruiting yet, but it offers a chance to explore new, non-drug options to help manage depression.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. adults (18-65 years old)
  • 2. Ability to provide informed consent
  • 3. English language proficiency
  • 4. PHQ-9 score \> 10, indicating at least moderate depressive symptoms 21
  • 5. Must have filled out the waiver for the community-based partners prior to enrolling in the study\*
  • 6. Individuals of childbearing potential must use an acceptable form of birth control
  • 7. (if applicable) willingness to keep psychiatric medications and psychotherapy stable throughout the course of the study
  • 8. Must be able to the Insight Timer app on a device
  • Exclusion Criteria:
  • 1. Pregnant or planning to become pregnant
  • 2. Breast feeding
  • 3. Active suicidal thinking (i.e., PHQ-9 item 9 ≥1 and a positive response to C-SSRS screener items 3, 4, 5, or 6)
  • 4. Active eating disorders or substance use disorders within the past 12 months, as per the Composite International Diagnostic Interview Screening Scales (CIDI-SC)
  • 5. Primary OCD or PTSD, as per the Composite International Diagnostic Interview Screening Scales (CIDI-SC)
  • 6. History of bipolar disorder, psychotic disorders, as per the Composite International Diagnostic Interview Screening Scales (CIDI-SC)
  • 7. ≥25% drop in PHQ-9 score from screen to baseline
  • 8. Under the influence or withdrawal of drugs or alcohol
  • 9. 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 PI or designee)
  • 10. have had a bone fracture or joint surgery in the past 6 months
  • 11. not able to walk freely or without difficulty
  • 12. any serious, unstable medical condition as determined by the revised Physical Activity Readiness Questionnaire (PAR-Q+) and do not have approval from their treating physician (the investigator will check in with treating physician in the event that participants endorse any item on the PAR-Q+)
  • 13. participants must have a physician responsible for their medical care
  • 14. Significant exposure to heated yoga classes in the past 3 months (i.e., more than 6 classes)
  • 15. Significant exposure to sauna sessions in the past 3 months (i.e., more than 6 sessions)
  • 16. Significant exposure to mindfulness app in the past 3 months (i.e., more than 6 uses of the app)
  • 17. are on medications that make dehydration more likely (e.g., lithium, antipsychotics, insulin-dependent) diuretics, barbiturates, b-blockers, anticholinergics, current ETOH acute intoxication, reduced ability to sweat, hemophilia, pacemaker (magnets used to assemble saunas can interrupt the pacer), glomerular filtration rate (GFR) \< 45 ml/min, BP \>160/110.
  • 18. antidepressant or psychiatric medications that are initiated less than 8 weeks or a dose change less than 4 weeks prior to screening visit
  • 19. psychotherapy that has been initiated within the past 3 months
  • 20. psychiatric hospitalization within the past year
  • 21. diagnosed with any neurological disorders that would impact participation or make participation unsafe
  • 22. are currently in active ketamine, Electroconvulsive therapy, or Transcranial Magnetic Stimulation treatments
  • 23. are unable to follow the study procedures (e.g., not able to travel to the heated yoga or sauna studios)
  • 24. A subject who, in the opinion of the Principal Investigator, would not be able to safely complete the study or would jeopardize study integrity

About Massachusetts General Hospital

Massachusetts General Hospital (MGH) is a leading academic medical center located in Boston, Massachusetts, renowned for its commitment to advancing medical research and patient care. As a prominent teaching hospital affiliated with Harvard Medical School, MGH plays a pivotal role in clinical trials across a wide range of disciplines, including cardiology, oncology, neurology, and more. The institution is dedicated to fostering innovative research that translates into effective therapies and improved health outcomes. MGH's Clinical Trials Office provides comprehensive support to facilitate the design, implementation, and management of clinical studies, ensuring adherence to the highest ethical standards and regulatory compliance. With a focus on collaboration and patient-centered care, MGH strives to enhance medical knowledge and contribute to the future of healthcare.

Locations

Boston, Massachusetts, United States

Patients applied

0 patients applied

Trial Officials

Maren B Nyer, PhD

Principal Investigator

Massachusetts General Hospital

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported