Comparing the Efficacy of Heated Yoga and Sauna as a Treatment for Depression
NCT ID: NCT07082998
Last Updated: 2025-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
120 participants
INTERVENTIONAL
2025-09-12
2027-07-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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heated yoga
heated yoga 2x per week for 12 weeks
heated yoga
12-weeks of twice weekly 90-min heated yoga classes in the community
sauna
infrared sauna 2x per week for 12 weeks
sauna
12-weeks of twice weekly 40-min sauna sessions in the community
mindfulness app
Insight Timer app for 80 mins per week for 12 weeks
mindfulness app
12-weeks of 80-mins a week of a mindfulness app
Interventions
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sauna
12-weeks of twice weekly 40-min sauna sessions in the community
mindfulness app
12-weeks of 80-mins a week of a mindfulness app
heated yoga
12-weeks of twice weekly 90-min heated yoga classes in the community
Eligibility Criteria
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Inclusion Criteria
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 access mindfulness app on a device (i.e., smartphone, iPad, etc.)
9. Can travel to Breathe in Harvard Square and at least one Restore location (i.e., Hingham, Somerville, Dedham, Newton, Lynnfield)
Exclusion Criteria
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 MINI
5. Primary OCD or PTSD, as per the MINI
6. History of bipolar disorder, psychotic disorders, as per the MINI
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 (we will check in with treating physician in the event that participants endorse any item on the PAR-Q+)
13. 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.
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)
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
18 Years
65 Years
ALL
No
Sponsors
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Massachusetts General Hospital
OTHER
Responsible Party
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Maren Nyer
clinical psychologist
Principal Investigators
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Maren B Nyer, PhD
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Locations
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Massachusetts General Hospital
Boston, Massachusetts, United States
Countries
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Central Contacts
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Facility Contacts
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Maren B Nyer, PhD
Role: primary
David Mischoulon, MD, PhD
Role: backup
Other Identifiers
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2025P001188
Identifier Type: -
Identifier Source: org_study_id