Researching Heat and Yoga for Mood Enhancement (RHYME)

November 11, 2025 updated by: Maren Nyer, Massachusetts General Hospital

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Massachusetts
      • Cambridge, Massachusetts, United States, 02139
        • Recruiting
        • Orange Door Collaborative
      • Cambridge, Massachusetts, United States, 02142

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. adults (18-65 years old)
  2. able to provide consent
  3. are able to read and understand English
  4. PHQ-9 score between 10-20, indicating moderate but not severe depressive symptom severity (27)
  5. Must have filled out the waiver for the community-based yoga studio prior to enrolling in the study.

Exclusion Criteria:

  1. have had a bone fracture or joint surgery in the past 6 months
  2. not able to walk freely or without difficulty
  3. have severe heart failure or lung disease
  4. 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+)
  5. participants must have a physician responsible for their medical care
  6. are pregnant or planning to become pregnant
  7. no more than 6 yoga classes in the past 6 months
  8. 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)
  9. report manic symptoms (Altman Self-Rating Mania Scale score ≥ 6 (28))
  10. are on medications that make dehydration more likely (e.g., lithium, antipsychotics, insulin-dependent)
  11. active eating disorders or substance use disorders within the past 12 months
  12. antidepressant or psychiatric medications that are initiated less than 8 weeks or a dose change less than 4 weeks prior to screening visit
  13. psychotherapy that has been initiated within the past 3 months
  14. willingness to keep psychiatric medications and psychotherapy stable throughout the course of the study
  15. psychiatric hospitalization within the past year
  16. diagnosed with any neurological disorders that would impact participation or make participation unsafe
  17. are currently in any active ketamine, ECT, or TMS
  18. are unable to follow the study procedures (e.g., not able to travel to the heated or non-heated yoga studios)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Heated Yoga
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.
Behavioral: Heated Yoga
Heated yoga described in arm/group description
Active Comparator: Non-heated Yoga
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.
Behavioral: Non-Heated Yoga
Non-heated yoga described in arm/group description

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Weeks 0, 4, 8, and 20

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The World Health Organization-5 Well-Being Index (WHO-5)
Time Frame: Weeks 0, 4, 8, and 20
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.
Weeks 0, 4, 8, and 20
Patient Reported Outcomes Measurement Information System-29 (PROMIS-29)
Time Frame: Weeks 0, 4, 8, and 20
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.
Weeks 0, 4, 8, and 20
Ruminative Responses Scale (RRS)
Time Frame: Weeks 0, 4, 8, and 20
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).
Weeks 0, 4, 8, and 20
The Five Facet Mindfulness Questionnaire (FFMQ-15)
Time Frame: Weeks 0, 4, 8, and 20
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).
Weeks 0, 4, 8, and 20

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Massachusetts General Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Tiny Blue Dot Foundation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 17, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 17, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 23, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 13, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 11, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2023p001916

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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