Depression DisordersSHINENCT07082998
Comparing the Efficacy of Heated Yoga and Sauna as a Treatment for Depression
A study testing heated yoga, sauna and mindfulness app in people with Depression Disorders and Depression - Major Depressive Disorder, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
This project explores whether heated yoga, sauna, and a mindfulness app reduce depressive symptoms Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression Disorders, Depression - Major Depressive Disorder, Depression Disorder
- What is being tested?
- heated yoga, sauna and mindfulness app
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Sep 2025to 31 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- (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)
Who cannot join
- 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
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- ≥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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Maren B Nyer, PhD, 617-726-8895, mnyer@mgh.harvard.edu
David Mischoulon, MD, PhD, 617-726-8895, dmischoulon@mgh.harvard.edu
About this study
This project explores whether heated yoga, sauna, and a mindfulness app reduce depressive symptoms
Read the 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 4-week (Week 16). Then participants enter an optional 1-month choice intervention period with a post-assessment (Week 20).
- Conditions
- Depression Disorders, Depression - Major Depressive Disorder, Depression Disorder, Depression Chronic, Depression, Depression in Adults
- Being tested
- heated yoga, sauna, mindfulness app
- Keywords
- depression, heated yoga, yoga, sauna, mindfulness, mindfulness app, clinical trial
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
heated yogaBehavioural
12-weeks of twice weekly 90-min heated yoga classes in the community
saunaBehavioural
12-weeks of twice weekly 40-min sauna sessions in the community
mindfulness appBehavioural
12-weeks of 80-mins a week of a mindfulness app
| Study group | Role | What they receive |
|---|---|---|
| heated yoga | Experimental | heated yoga 2x per week for 12 weeks Receives: Behavioral: heated yoga |
| sauna | Experimental | infrared sauna 2x per week for 12 weeks Receives: Behavioral: sauna |
| mindfulness app | Active comparator | Insight Timer app for 80 mins per week for 12 weeks Receives: Behavioral: mindfulness app |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Health Questionnaire (PHQ-9)
The PHQ- 9 is a 9-item self-report questionnaire that is widely used to assess depression symptom severity. Score range from 0 to 27, with a high score (20-27) indicating severe depression.
Measured: Weeks 0, 4, 8, 12, 26, 20
Secondary outcomes (4)
The Five Facet Mindfulness Questionnaire (FFMQ-15)
A 15-item self-report instrument that measures mindfulness; derived from factor analytic study of five independent mindfulness questionnaires. Total scores range from 15 to 75, with higher scores indicating greater utilization of mindfulness techniques.
Measured: Weeks 0, 4, 8, 12, 16, 20
Ruminative Responses Scale (RRS)
A 22-item questionnaire that assess rumination, with scores range from 22 to 88. Lower scores reflect less frequent engagement in ruminative thought patterns.
Measured: Weeks 0, 4, 8, 12, 16, 20
The World Health Organization-5 Well-Being Index (WHO-5)
A 5-item self-report questionnaire with positively-worded statements related to general mood over the prior two weeks. WHO-5 has shown strong construct validity as a measure of general quality of life, and is sensitive to change. Scores range from 0 to 25, with higher scores reflecting overall well-being.
Measured: Weeks 0, 4, 8, 12, 16, 20
Patient-Reported Outcomes Measurement Information System (PROMIS-29)
PROMIS-29 is used to assess psychometric properties under the domains of physical function, fatigue, pain interference, depressive symptoms, anxiety, social functioning, sleep disturbance using four items per domain. This measure uses a T-score metric for scoring, typically ranging from 20 to 80, with a lower T-score (below 50) indicating less severity of symptoms.
Measured: Weeks 0, 4, 8, 12, 16, 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2025
- Study start12 Sep 2025
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression DisordersStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maren Nyer, Massachusetts General Hospital
- Investigators
- Maren B Nyer, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07082998
- Sponsor's protocol ID
- 2025P001188
- Acronym
- SHINE
- Status last verified
- Jul 2026
- First submitted
- 16 Jul 2025
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Efficacy of Heated Yoga and Sauna as a Treatment for Depression
- ClinicalTrials.gov ID
- NCT07082998
- Acronym / sponsor ID
- SHINE / 2025P001188
- Conditions
- Depression Disorders, Depression - Major Depressive Disorder, Depression Disorder, Depression Chronic, Depression, Depression in Adults
- Keywords
- depression, heated yoga, yoga, sauna, mindfulness, mindfulness app, clinical trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 12 Sep 2025 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 24 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project explores whether heated yoga, sauna, and a mindfulness app reduce depressive symptoms
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 4-week (Week 16). Then participants enter an optional 1-month choice intervention period with a post-assessment (Week 20).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| heated yoga | Experimental | Behavioral: heated yogaheated yoga 2x per week for 12 weeks |
| sauna | Experimental | Behavioral: saunainfrared sauna 2x per week for 12 weeks |
| mindfulness app | Active comparator | Behavioral: mindfulness appInsight Timer app for 80 mins per week for 12 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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*
Key exclusion criteria (24 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| heated yoga12-weeks of twice weekly 90-min heated yoga classes in the community | Behavioural | heated yoga |
| sauna12-weeks of twice weekly 40-min sauna sessions in the community | Behavioural | sauna |
| mindfulness app12-weeks of 80-mins a week of a mindfulness app | Behavioural | mindfulness app |
Primary outcome
Patient Health Questionnaire (PHQ-9)
Time frame: Weeks 0, 4, 8, 12, 26, 20
The PHQ- 9 is a 9-item self-report questionnaire that is widely used to assess depression symptom severity. Score range from 0 to 27, with a high score (20-27) indicating severe depression.
4 secondary outcomes
The Five Facet Mindfulness Questionnaire (FFMQ-15)
Time frame: Weeks 0, 4, 8, 12, 16, 20
Ruminative Responses Scale (RRS)
Time frame: Weeks 0, 4, 8, 12, 16, 20
The World Health Organization-5 Well-Being Index (WHO-5)
Time frame: Weeks 0, 4, 8, 12, 16, 20
Patient-Reported Outcomes Measurement Information System (PROMIS-29)
Time frame: Weeks 0, 4, 8, 12, 16, 20
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Maren B Nyer, PhD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing heated yoga, sauna and mindfulness app in people with Depression Disorders and Depression - Major Depressive Disorder, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maren B Nyer, PhD (617-726-8895, mnyer@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Health Questionnaire (PHQ-9) (time frame: Weeks 0, 4, 8, 12, 26, 20). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.