RHYME: Examining the Impact of Heated Yoga on Mindfulness and Rumination

Sponsor
Massachusetts General Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06094088
Collaborator
Tiny Blue Dot Foundation (Other)
120
4
36

Study Details

Study Description

Brief Summary

This study will examine how doing yoga in a heated room can expand an individual's mindfulness and decrease rumination.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: heated yoga
  • Behavioral: non-heated yoga
  • Behavioral: heated health education
  • Behavioral: non-heated health education
N/A

Detailed Description

The purpose of this study is to investigate the effects of heated yoga on expanding one's perception box, specifically focusing on improvements in mindfulness and reduced rumination. The study will compare heated yoga to non-heated yoga, heat alone, and a no yoga/no heat control group. Previous research on heated yoga intervention for depression has shown promising results, including increased mindfulness and decreased rumination. The researchers aim to extend this work to a non-clinical sample experiencing distress but not meeting clinical criteria for depression. The heated yoga intervention will be conducted in a state-of-the-art heated dome, while the non-heated yoga group will follow a standardized protocol. The heat only group will be exposed to the same heat environment as the heated yoga group, and the control groups will receive health education materials. Eligible participants will be adults who do not regularly practice yoga or meditation but have low levels of mindfulness. Assessments will be conducted at baseline, post-treatment, and follow-up using a secure data capture system.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Examining the Impact of Heated Yoga on Mindfulness and Rumination
Anticipated Study Start Date :
Dec 1, 2023
Anticipated Primary Completion Date :
Sep 1, 2026
Anticipated Study Completion Date :
Dec 1, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: heated yoga

The heated yoga will be a standardized 90-minute protocol. Classes consist of 26 Hatha yoga postures bookended by 2 breathing exercises conducted in the same sequence for each class. 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 done on the mat. We will use inflatable individual yoga domes to create this standardized atmosphere as they are feasible (e.g., can be easily moved and stored) while providing an accurate and safe environment for a heated condition.

Behavioral: heated yoga
heated yoga described in arm/group description

Active Comparator: non-heated yoga

The non-heated yoga will be receiving the exact same standardized 90-minute protocol used in two prior studies of heated yoga, and described above, except these participants will not be in an at-home inflatable dome. Instructors will teach the heated and non-heated yoga classes virtually.

Behavioral: non-heated yoga
non-heated yoga described in arm/group description

Active Comparator: heated health education

The heat only group will be exposed to the same heat environment of the heated yoga group (in the heated, inflatable at-home domes) for 90-minutes and will receive a health education control (HEC). The HEC condition will consist of an 8-week health education course consisting of twice a week 90 minute education sessions. The sessions will cover important health topics.

Behavioral: heated health education
heated health education described in arm/group description

Active Comparator: non-heated health education

Same HEC classes as above but not in a heated dome.

Behavioral: non-heated health education
non-heated health education described in arm/group description

Outcome Measures

Primary Outcome Measures

  1. Ruminative Responses Scale (RRS) [Weeks 0, 8, and 20]

    This measure is a 22-item questionnaire, commonly used to assess rumination.

  2. The Five Facet Mindfulness Questionnaire (FFMQ-15)(33) [Weeks 0, 8, and 20]

    A self-report instrument that measures mindfulness; derived from factor analytic study of five independent mindfulness questionnaires.

Secondary Outcome Measures

  1. Patient Health Questionnaire-9 (PHQ-9) [Weeks 0, 8, and 20]

    This measure is a 9-item self-report questionnaire that is widely used to assess depression symptom severity. 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.

  2. The World Health Organization-5 Well-Being Index (WHO-5) [Weeks 0, 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.

  3. PROMIS-29 [Weeks 0, 8, and 20]

    This measure has seven health domains (physical function, fatigue, pain interference, depressive symptoms, anxiety, social functioning, sleep disturbance) using four items per domain.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  1. adults (≥18 years old)

  2. at least moderate difficulty with rumination at study entry (RRS score > 50)

  3. provide informed consent

  4. are able to read and understand English

Exclusion Criteria:
  1. are 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. are already engaged in yoga practice on a weekly basis

  9. have active suicidal thinking (i.e., PHQ-9 item 9 ≥1 and a positive response to CSSR-S screener items 2, 3, 4, 5, or 6

  10. are currently manic (Altman Self-Rating Mania Scale score ≥ 6(30))

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

  12. are unable to setup, make space for, or stay in the inflatable dome for 90-minute intervention sessions

  13. do not own a device that is able to complete the study procedures (e.g., online assessments, video conferencing for classes)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Massachusetts General Hospital
  • Tiny Blue Dot Foundation

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Maren Nyer, Clinical Psychologist, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT06094088
Other Study ID Numbers:
  • 2023p001916
First Posted:
Oct 23, 2023
Last Update Posted:
Oct 23, 2023
Last Verified:
Oct 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 23, 2023