Examining the Impact of Heated Yoga on Mindfulness and Rumination

Depression Clinical Trial

— RHYME  

Official title:

Examining the Impact of Heated Yoga on Mindfulness and Rumination

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06094088
• Other study ID #: 2023p001916
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2024
• Est. completion date: December 1, 2026

Study information

• Verified date: March 2024
• Source: Massachusetts General Hospital
• Contact: Maren Nyer, PhD
• Phone: 617-726-8895
• Email: mnyer[@]mgh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: December 1, 2026
• Est. primary completion date: September 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. adults (=18 years old)

2. provide informed 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)

Exclusion Criteria:

1. older adults (> 65 years old)

2. have had a bone fracture or joint surgery in the past 6 months

3. are unable to walk

4. have severe heart failure or lung disease

5. 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+)

6. participants must have a physician responsible for their medical care

7. are pregnant or planning to become pregnant

8. no more than 6 yoga classes in the past 6 months

9. have active suicidal thinking (i.e., PHQ-9 item 9 =1)

10. report manic symptoms (Altman Self-Rating Mania Scale score = 6 (28))

11. are on medications that make dehydration more likely (e.g., stimulants, lithium, antipsychotics)

12. active eating disorders or substance use disorders within the past 12 months

13. antidepressant or psychiatric medications that are initiated less than 8 weeks or a dose change less than 4 weeks prior to screening visit

14. psychotherapy that has been initiated within the past 3 months

15. willingness to keep psychiatric medications and psychotherapy stable throughout the course of the study

16. psychiatric hospitalization within the past year

17. diagnosed with any neurological disorders that would impact participation or make participation unsafe

18. are not currently in any active ketamine, ECT, or TMS

19. are unable to follow the study procedures (e.g., not able to travel to the heated or non-heated yoga studios)

Related Conditions & MeSH terms

• Depression

Intervention

Behavioral:
• Heated Yoga
Heated yoga described in arm/group description
• Non-Heated Yoga
Non-heated yoga described in arm/group description

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Tiny Blue Dot Foundation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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