RecruitingNot ApplicableNCT07082998

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


Sponsor

Massachusetts General Hospital

Enrollment

120 participants

Start Date

Sep 12, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This project explores whether heated yoga, sauna, and a mindfulness app reduce depressive symptoms


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria10

  • Subject Characteristics
  • adults (18-65 years old)
  • Ability to provide informed consent
  • English language proficiency
  • PHQ-9 score \> 10, indicating at least moderate depressive symptoms 21
  • Must have filled out the waiver for the community-based partners prior to enrolling in the study\*
  • Individuals of childbearing potential must use an acceptable form of birth control
  • (if applicable) willingness to keep psychiatric medications and psychotherapy stable throughout the course of the study
  • Must be able to access mindfulness app on a device (i.e., smartphone, iPad, etc.)
  • Can travel to Breathe in Harvard Square and at least one Restore location (i.e., Hingham, Somerville, Dedham, Newton, Lynnfield)

Exclusion Criteria24

  • Pregnant or planning to become pregnant
  • Breast feeding
  • Active suicidal thinking (i.e., PHQ-9 item 9 ≥1 and a positive response to C-SSRS screener items 3, 4, 5, or 6)
  • Active eating disorders or substance use disorders within the past 12 months, as per the MINI
  • Primary OCD or PTSD, as per the MINI
  • History of bipolar disorder, psychotic disorders, as per the MINI
  • ≥25% drop in PHQ-9 score from screen to baseline
  • Under the influence or withdrawal of drugs or alcohol
  • 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)
  • have had a bone fracture or joint surgery in the past 6 months
  • not able to walk freely or without difficulty
  • 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 (we will check in with treating physician in the event that participants endorse any item on the PAR-Q+)
  • participants must have a healthcare provider who they could contact if they needed medical care, such as a primary care doctor, a counselor, a psychiatrist, a nurse practitioner, or a clinic that you go to.
  • Significant exposure to heated yoga classes in the past 3 months (i.e., more than 6 classes)
  • Significant exposure to sauna sessions in the past 3 months (i.e., more than 6 sessions)
  • Significant exposure to mindfulness app in the past 3 months (i.e., more than 6 uses of the app)
  • 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)
  • antidepressant or psychiatric medications that are initiated less than 8 weeks or a dose change less than 4 weeks prior to screening visit
  • psychotherapy that has been initiated within the past 3 months
  • psychiatric hospitalization within the past year
  • diagnosed with any neurological disorders that would impact participation or make participation unsafe
  • are currently in active ketamine, Electroconvulsive therapy, or Transcranial Magnetic Stimulation treatments
  • are unable to follow the study procedures (e.g., not able to travel to the heated yoga or sauna studios)
  • A subject who in the opinion of the Principal Investigator would not be able to safely complete the study or would jeopardize study integrity

Interventions

BEHAVIORALheated yoga

12-weeks of twice weekly 90-min heated yoga classes in the community

BEHAVIORALsauna

12-weeks of twice weekly 40-min sauna sessions in the community

BEHAVIORALmindfulness app

12-weeks of 80-mins a week of a mindfulness app


Locations(1)

Massachusetts General Hospital

Boston, Massachusetts, United States

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NCT07082998


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