DepressionRHYMENCT06094088
Researching Heat and Yoga for Mood Enhancement
A study testing Heated Yoga and Non-Heated Yoga in people with Depression, run by Massachusetts General Hospital at 2 sites in United States.
Trial summary
This study will examine how doing heated yoga or non-heated yoga affects depression. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression
- What is being tested?
- Heated Yoga and Non-Heated Yoga
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jul 2025to 1 Dec 2026
- 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)
- able to provide consent
- are able to read and understand English
- PHQ-9 score between 10-20, indicating moderate but not severe depressive symptom severity (27)
- Must have filled out the waiver for the community-based yoga studio prior to enrolling in the study.
Who cannot join
- have had a bone fracture or joint surgery in the past 6 months
- not able to walk freely or without difficulty
- have severe heart failure or lung disease
- participants endorse an item on 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 physician responsible for their medical care
- are pregnant or planning to become pregnant
Show all 18Show fewer
- no more than 6 yoga classes in the past 6 months
- have active suicidal thinking (i.e., PHQ-9 item 9 ≥1 and a positive response to C-SSRS screener items 3, 4, 5, or 6)
- report manic symptoms (Altman Self-Rating Mania Scale score ≥ 6 (28))
- are on medications that make dehydration more likely (e.g., lithium, antipsychotics, insulin-dependent)
- active eating disorders or substance use disorders within the past 12 months
- 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
- willingness to keep psychiatric medications and psychotherapy stable throughout the course of the study
- psychiatric hospitalization within the past year
- diagnosed with any neurological disorders that would impact participation or make participation unsafe
- are currently in any active ketamine, ECT, or TMS
- are unable to follow the study procedures (e.g., not able to travel to the heated or non-heated yoga studios)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Orange Door Collaborative
Cambridge, Massachusetts, 02139
Breathe Yoga Studio
Cambridge, Massachusetts, 02142
About this study
Official title: Examining the Impact of Heated and Non-Heated Yoga on Depression
This study will examine how doing heated yoga or non-heated yoga affects depression.
Read the detailed description
The purpose of this study is to investigate the effects of heated and non-heated yoga on depressive symptoms. Previous research trials using heated and non-heated yoga interventions have shown promising results for reducing depression and its related outcomes. However, no studies have directly compared the effects of heated vs. non-heated yoga for depression. The researchers aim to address this gap by conducting a non-inferiority trial comparing heated yoga and non-heated yoga interventions to improve depressive symptoms. Both the heated and non-heated yoga interventions will be conducted in-person by certified yoga instructors. Eligible participants will be adults who do not regularly practice yoga or meditation and are experiencing moderate levels of depression. Assessments will be conducted at baseline, mid-treatment, post-treatment, and follow-up using a secure data capture system.
- Conditions
- Depression
- Being tested
- Heated Yoga, Non-Heated Yoga
- 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
Heated yoga described in arm/group description
Non-Heated YogaBehavioural
Non-heated yoga described in arm/group description
| Study group | Role | What they receive |
|---|---|---|
| Heated Yoga | Experimental | The heated (i.e., ~105°F with 40% humidity) yoga will be 90 minutes long and consist of 26 Hatha yoga postures and 2 breathing exercises. The class starts with standing postures for approximately 45-50 minutes, followed by a 2-minute savasana (or corpse pose on the floor) and the remainder of the 90-minute class is completed on the mat. All yoga teachers will be heated yoga certified. Receives: Behavioral: Heated Yoga |
| Non-heated Yoga | Active comparator | The non-heated (i.e., room temperature < 80°F) yoga will be 90 minutes long and consist of 26 Hatha yoga postures and 2 breathing exercises. The class starts with standing postures for approximately 45-50 minutes, followed by a 2-minute savasana (or corpse pose on the floor) and the remainder of the 90-minute class is completed on the mat. All yoga teachers will be heated yoga certified. Receives: Behavioral: Non-Heated Yoga |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Health Questionnaire-9 (PHQ-9)
This measure is a 9-item self-report questionnaire that is widely used to assess depression symptom severity. PHQ-9 scores range from 0 to 27. A PHQ-9 score ≥10 has a sensitivity of 88% and a specificity of 88% for major depression. PHQ-9 scores of 5, 10, 15, and 20 represented mild, moderate, moderately severe, and severe depression, respectively.
Measured: Weeks 0, 4, 8, and 20
Secondary outcomes (4)
The World Health Organization-5 Well-Being Index (WHO-5)
This measure is a 5-item self-report questionnaire with positively-worded statements related to positive mood, vitality, and general interest over the prior two weeks. The WHO-5 is reliable, has shown strong construct validity as a measure of general quality of life, and is sensitive to change. The WHO-5 has a score range of 0 to 25, with higher scores indicating better wellbeing.
Measured: Weeks 0, 4, 8, and 20
Patient Reported Outcomes Measurement Information System-29 (PROMIS-29)
This measure has seven health domains (physical function, fatigue, pain interference, depressive symptoms, anxiety, social functioning, sleep disturbance). The scale includes four items per domain, each scored from 1 to 5. The scale also includes one question at the end about pain intensity, which is scored from 0 to 10. The possible score for each domain ranges from 4 to 20 and the total possible score for the entire measure ranges from 28 to150. Higher scores indicate poorer outcomes.
Measured: Weeks 0, 4, 8, and 20
Ruminative Responses Scale (RRS)
This measure is a 22-item questionnaire, commonly used to assess rumination. Items are scored from 1 to 4, the scale has a possible range of 22 to 88, and higher scores indicate poorer outcomes (i.e. higher rumination).
Measured: Weeks 0, 4, 8, and 20
The Five Facet Mindfulness Questionnaire (FFMQ-15)
A self-report instrument that measures mindfulness; derived from factor analytic study of five independent mindfulness questionnaires. The scale contains 39 items, split into five domains (Observing, Describing, Acting with Awareness, Nonjudging, Nonreactivity), with each item being rated from 1 to 5. Some items are reverse coded. Total FFMQ scores range from 39 to 195, with greater scores indicating better outcomes (i.e. greater mindfulness).
Measured: Weeks 0, 4, 8, and 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start1 Jul 2025
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Tiny Blue Dot Foundation
- Responsible party
- Principal investigator, Maren Nyer, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06094088
- Sponsor's protocol ID
- 2023p001916
- Acronym
- RHYME
- Status last verified
- Sep 2026
- First submitted
- 17 Oct 2023
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Impact of Heated and Non-Heated Yoga on Depression
- ClinicalTrials.gov ID
- NCT06094088
- Acronym / sponsor ID
- RHYME / 2023p001916
- Conditions
- Depression
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Tiny Blue Dot Foundation
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 23 Oct 2023 (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 study will examine how doing heated yoga or non-heated yoga affects depression.
Detailed description
The purpose of this study is to investigate the effects of heated and non-heated yoga on depressive symptoms. Previous research trials using heated and non-heated yoga interventions have shown promising results for reducing depression and its related outcomes. However, no studies have directly compared the effects of heated vs. non-heated yoga for depression. The researchers aim to address this gap by conducting a non-inferiority trial comparing heated yoga and non-heated yoga interventions to improve depressive symptoms. Both the heated and non-heated yoga interventions will be conducted in-person by certified yoga instructors. Eligible participants will be adults who do not regularly practice yoga or meditation and are experiencing moderate levels of depression. Assessments will be conducted at baseline, mid-treatment, post-treatment, and follow-up using a secure data capture system.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Heated Yoga | Experimental | Behavioral: Heated YogaThe heated (i.e., ~105°F with 40% humidity) yoga will be 90 minutes long and consist of 26 Hatha yoga postures and 2 breathing exercises. The class starts with standing postures for approximately 45-50 minutes, followed by a 2-minute savasana (or corpse pose on the floor) and the remainder of the 90-minute class is completed on the mat. All yoga teachers will be heated yoga certified. |
| Non-heated Yoga | Active comparator | Behavioral: Non-Heated YogaThe non-heated (i.e., room temperature < 80°F) yoga will be 90 minutes long and consist of 26 Hatha yoga postures and 2 breathing exercises. The class starts with standing postures for approximately 45-50 minutes, followed by a 2-minute savasana (or corpse pose on the floor) and the remainder of the 90-minute class is completed on the mat. All yoga teachers will be heated yoga certified. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- adults (18-65 years old)
- able to provide consent
- are able to read and understand English
- PHQ-9 score between 10-20, indicating moderate but not severe depressive symptom severity (27)
- Must have filled out the waiver for the community-based yoga studio prior to enrolling in the study.
Key exclusion criteria (18 listed)
- have had a bone fracture or joint surgery in the past 6 months
- not able to walk freely or without difficulty
- have severe heart failure or lung disease
- participants endorse an item on 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 physician responsible for their medical care
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 YogaHeated yoga described in arm/group description | Behavioural | Heated Yoga |
| Non-Heated YogaNon-heated yoga described in arm/group description | Behavioural | Non-heated Yoga |
Primary outcome
Patient Health Questionnaire-9 (PHQ-9)
Time frame: Weeks 0, 4, 8, and 20
This measure is a 9-item self-report questionnaire that is widely used to assess depression symptom severity. PHQ-9 scores range from 0 to 27. A PHQ-9 score ≥10 has a sensitivity of 88% and a specificity of 88% for major depression. PHQ-9 scores of 5, 10, 15, and 20 represented mild, moderate, moderately severe, and severe depression, respectively.
4 secondary outcomes
The World Health Organization-5 Well-Being Index (WHO-5)
Time frame: Weeks 0, 4, 8, and 20
Patient Reported Outcomes Measurement Information System-29 (PROMIS-29)
Time frame: Weeks 0, 4, 8, and 20
Ruminative Responses Scale (RRS)
Time frame: Weeks 0, 4, 8, and 20
The Five Facet Mindfulness Questionnaire (FFMQ-15)
Time frame: Weeks 0, 4, 8, and 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 10 Sep 2026.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Heated Yoga and Non-Heated Yoga in people with Depression, run by Massachusetts General Hospital at 2 sites 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 5 inclusion and 18 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: under way, not looking for participants, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Health Questionnaire-9 (PHQ-9) (time frame: Weeks 0, 4, 8, and 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 10 Sep 2026.