Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06094088

Researching Heat and Yoga for Mood Enhancement

This study will examine how doing heated yoga or non-heated yoga affects depression.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Breathe Yoga Studio, Cambridge, Massachusetts, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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
  • 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)

Treatment and study plan

heated yoga

Behavioral

Heated yoga described in arm/group description

Non-heated yoga

Behavioral

Non-heated yoga described in arm/group description

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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).

  4. 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Louisa Sylvia, PhD

CONTACT

[email protected]

617-726-5855

Maren Nyer, PhD

CONTACT

[email protected]

617-726-8895

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • Tiny Blue Dot Foundation

Registry information

Official study title

Examining the Impact of Heated and Non-Heated Yoga on Depression

Acronym: RHYME

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Oct 23, 2023
Registry last updated
Nov 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.