Heated yoga, sauna, or a mindfulness app for depression

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, parallel-group study that will enroll 120 adults with at least moderate depressive symptoms (PHQ-9 >10) and randomly assign them 1:1:1 to heated yoga, sauna, or a mindfulness app for 12 weeks. Assessments occur at baseline, mid-intervention (weeks 4 and 8), at the end of the 12-week intervention (primary outcome), and at a 4-week follow-up (week 16), with an optional one-month choice period and a week 20 post-assessment. Interventions are provided in community locations for the in-person arms and via a smartphone/tablet for the app arm, and participants must keep psychiatric treatments stable if applicable. Safety exclusions include pregnancy, active suicidal thinking, and active eating or substance use disorders.

Why it matters

Who can join: the full rules

Subject Characteristics

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 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:

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 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

Where it's running

• Massachusetts General Hospital
  Boston, Massachusetts, United States Recruiting

Study contacts

• Principal investigator: Maren B Nyer, PhD — Massachusetts General Hospital
• Study coordinator: Maren B Nyer, PhD
• Email: mnyer@mgh.harvard.edu
• Phone: 617-726-8895

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.