[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100599323":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":37,"centralContacts":41,"locations":50,"responsibleParty":69,"collaborators":30,"id":72,"slug":73,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":76,"acronym":30,"eligibilityCriteria":77,"healthyVolunteers":74,"sex":78,"minAge":79,"maxAge":80,"enrollmentInfo":81,"targetDuration":30,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":95,"overallStatus":52,"whyStopped":30,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},{"fullName":5,"class":6},"Massachusetts General Hospital","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"heated yoga","EXPERIMENTAL","heated yoga 2x per week for 12 weeks",[13],"Behavioral: heated yoga",{"label":15,"type":10,"description":16,"interventionNames":17},"sauna","infrared sauna 2x per week for 12 weeks",[18],"Behavioral: sauna",{"label":20,"type":21,"description":22,"interventionNames":23},"mindfulness app","ACTIVE_COMPARATOR","Insight Timer app for 80 mins per week for 12 weeks",[24],"Behavioral: mindfulness app",[26,31,34],{"type":27,"name":9,"description":28,"armGroupLabels":29,"otherNames":30},"BEHAVIORAL","12-weeks of twice weekly 90-min heated yoga classes in the community",[9],null,{"type":27,"name":15,"description":32,"armGroupLabels":33,"otherNames":30},"12-weeks of twice weekly 40-min sauna sessions in the community",[15],{"type":27,"name":20,"description":35,"armGroupLabels":36,"otherNames":30},"12-weeks of 80-mins a week of a mindfulness app",[20],[38],{"name":39,"affiliation":5,"role":40},"Maren B Nyer, PhD","PRINCIPAL_INVESTIGATOR",[42,46],{"name":39,"role":43,"phone":44,"phoneExt":30,"email":45},"CONTACT","617-726-8895","mnyer@mgh.harvard.edu",{"name":47,"role":43,"phone":48,"phoneExt":30,"email":49},"Yian Wu, MPH","617-743-3370","yiwu4@mgh.harvard.edu",[51],{"facility":5,"status":52,"city":53,"state":54,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"RECRUITING","Boston","Massachusetts","02114","United States","US",{"type":59,"coordinates":60},"Point",[61,62],-71.05977,42.35843,{"lat":62,"lon":61},[65,66],{"name":39,"role":43,"phone":44,"phoneExt":30,"email":45},{"name":67,"role":43,"phone":44,"phoneExt":30,"email":68},"David Mischoulon, MD, PhD","dmischoulon@mgh.harvard.edu",{"type":40,"investigatorFullName":70,"investigatorTitle":71,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"Maren Nyer","clinical psychologist","100599323","comparing-the-efficacy-of-heated-yoga-and-sauna-as-a-treatment-for-depression-100599323",false,"NCT07082998","Comparing the Efficacy of Heated Yoga and Sauna as a Treatment for Depression","Subject Characteristics\n\nInclusion Criteria:\n\n1. adults (18-65 years old)\n2. Ability to provide informed consent\n3. English language proficiency\n4. PHQ-9 score \\> 10, indicating at least moderate depressive symptoms 21\n5. Must have filled out the waiver for the community-based partners prior to enrolling in the study\\*\n6. Individuals of childbearing potential must use an acceptable form of birth control\n7. (if applicable) willingness to keep psychiatric medications and psychotherapy stable throughout the course of the study\n8. Must be able to access mindfulness app on a device (i.e., smartphone, iPad, etc.)\n9. Can travel to Breathe in Harvard Square and at least one Restore location (i.e., Hingham, Somerville, Dedham, Newton, Lynnfield)\n\nExclusion Criteria:\n\n1. Pregnant or planning to become pregnant\n2. Breast feeding\n3. Active suicidal thinking (i.e., PHQ-9 item 9 ≥1 and a positive response to C-SSRS screener items 3, 4, 5, or 6)\n4. Active eating disorders or substance use disorders within the past 12 months, as per the MINI\n5. Primary OCD or PTSD, as per the MINI\n6. History of bipolar disorder, psychotic disorders, as per the MINI\n7. ≥25% drop in PHQ-9 score from screen to baseline\n8. Under the influence or withdrawal of drugs or alcohol\n9. 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)\n10. have had a bone fracture or joint surgery in the past 6 months\n11. not able to walk freely or without difficulty\n12. 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+)\n13. 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.\n14. Significant exposure to heated yoga classes in the past 3 months (i.e., more than 6 classes)\n15. Significant exposure to sauna sessions in the past 3 months (i.e., more than 6 sessions)\n16. Significant exposure to mindfulness app in the past 3 months (i.e., more than 6 uses of the app)\n17. 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)\n18. antidepressant or psychiatric medications that are initiated less than 8 weeks or a dose change less than 4 weeks prior to screening visit\n19. psychotherapy that has been initiated within the past 3 months\n20. psychiatric hospitalization within the past year\n21. diagnosed with any neurological disorders that would impact participation or make participation unsafe\n22. are currently in active ketamine, Electroconvulsive therapy, or Transcranial Magnetic Stimulation treatments\n23. are unable to follow the study procedures (e.g., not able to travel to the heated yoga or sauna studios)\n24. A subject who in the opinion of the Principal Investigator would not be able to safely complete the study or would jeopardize study integrity","ALL","18 Years","65 Years",{"count":82,"type":83},120,"ESTIMATED","INTERVENTIONAL",[86],"NA","This project explores whether heated yoga, sauna, and a mindfulness app reduce depressive symptoms",[89,90,91,92,93,94],"Depression Disorders","Depression - Major Depressive Disorder","Depression Disorder","Depression Chronic","Depression","Depression in Adults",[96,9,97,15,98,20,99],"depression","yoga","mindfulness","clinical trial","2025-11-11",{"date":102,"type":103},"2025-11-13","ACTUAL",{"date":105,"type":103},"2025-09-12",{"date":107,"type":83},"2027-07-31",{"name":5,"class":6},1]