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)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07082998
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