Purpose

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

Conditions

Eligibility

Eligible Ages
Between 18 Years and 65 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
heated yoga
heated yoga 2x per week for 12 weeks
  • Behavioral: heated yoga
    12-weeks of twice weekly 90-min heated yoga classes in the community
Experimental
sauna
infrared sauna 2x per week for 12 weeks
  • Behavioral: sauna
    12-weeks of twice weekly 40-min sauna sessions in the community
Active Comparator
mindfulness app
Insight Timer app for 80 mins per week for 12 weeks
  • Behavioral: mindfulness app
    12-weeks of 80-mins a week of a mindfulness app

Recruiting Locations

Massachusetts General Hospital
Boston 4930956, Massachusetts 6254926 02114
Contact:
Maren B Nyer, PhD
617-726-8895
mnyer@mgh.harvard.edu

More Details

Status
Recruiting
Sponsor
Massachusetts General Hospital

Study Contact

Maren B Nyer, PhD
617-726-8895
mnyer@mgh.harvard.edu

Detailed Description

This is a parallel group study design. The investigators plan to enroll 120 adults who have at least moderate depression and will be randomized in an equal allocation ratio (i.e., 1:1:1) across three groups: heated yoga vs. sauna vs. a mindfulness app. The interventions will be provided over a 12-week period and assessments will occur at baseline (Week 0), mid-intervention (Weeks 4 & 8), post-intervention (Week 12, primary outcome), and at a 6-week (Week 18) and 3-month follow-up (Week 24).

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.