NCT07082998 · Massachusetts General Hospital
Comparing the Efficacy of Heated Yoga and Sauna as a Treatment for Depression
(SHINE)
What this study is about
This project explores whether heated yoga, sauna, and a mindfulness app reduce depressive symptoms
View original scientific description
This project explores whether heated yoga, sauna, and a mindfulness app reduce depressive symptoms
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 criteria
- 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
Where
- Boston, Massachusetts
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 6, 2026 · Source of record for eligibility and locations