Researching Heat and Yoga for Mood Enhancement (RHYME)

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: Recruiting
• Conditions: Depression
• Intervention / Treatment: Behavioral: Heated Yoga; Behavioral: Non-Heated Yoga

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: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maren Nyer, PhD; Phone Number: 617-726-8895; Email: mnyer@mgh.harvard.edu
• Study Contact Backup: Name: Louisa Sylvia, PhD; Phone Number: 617-726-5855; Email: lsylvia2@mgh.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Cambridge, Massachusetts, United States, 02139
      • Recruiting
      • Orange Door Collaborative
    • Cambridge, Massachusetts, United States, 02142
      • Recruiting
      • Breathe Yoga Studio
      • Contact: Shelley Cates; Phone Number: 617.547.9328; Email: hello@breathecambridge.com

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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.	Weeks 0, 4, 8, and 20

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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).	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).	Weeks 0, 4, 8, and 20

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: Tiny Blue Dot Foundation

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: October 17, 2023
• First Submitted That Met QC Criteria: October 17, 2023
• First Posted (Actual): October 23, 2023

Study Record Updates

• Last Update Posted (Estimated): November 13, 2025
• Last Update Submitted That Met QC Criteria: November 11, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Behavior; Depression
• Other Study ID 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