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Examining the Impact of Heated Yoga on Mindfulness and Rumination (RHYME)

Primary Purpose

Rumination, Mindfulness

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
heated yoga
non-heated yoga
heated health education
non-heated health education
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rumination

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: adults (≥18 years old) at least moderate difficulty with rumination at study entry (RRS score > 50) provide informed consent are able to read and understand English Exclusion Criteria: are older adults (> 65 years old) have had a bone fracture or joint surgery in the past 6 months are unable to walk 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 are already engaged in yoga practice on a weekly basis 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 are currently manic (Altman Self-Rating Mania Scale score ≥ 6(30)) are on medications that make dehydration more likely (e.g., stimulants, lithium) are unable to setup, make space for, or stay in the inflatable dome for 90-minute intervention sessions do not own a device that is able to complete the study procedures (e.g., online assessments, video conferencing for classes)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    heated yoga

    non-heated yoga

    heated health education

    non-heated health education

    Arm Description

    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.

    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.

    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.

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

    Outcomes

    Primary Outcome Measures

    Ruminative Responses Scale (RRS)
    This measure is a 22-item questionnaire, commonly used to assess rumination.
    The Five Facet Mindfulness Questionnaire (FFMQ-15)(33)
    A self-report instrument that measures mindfulness; derived from factor analytic study of five independent mindfulness questionnaires.

    Secondary Outcome Measures

    Patient Health Questionnaire-9 (PHQ-9)
    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.
    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.
    PROMIS-29
    This measure has seven health domains (physical function, fatigue, pain interference, depressive symptoms, anxiety, social functioning, sleep disturbance) using four items per domain.

    Full Information

    First Posted
    October 17, 2023
    Last Updated
    October 17, 2023
    Sponsor
    Massachusetts General Hospital
    Collaborators
    Tiny Blue Dot Foundation
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06094088
    Brief Title
    Examining the Impact of Heated Yoga on Mindfulness and Rumination
    Acronym
    RHYME
    Official Title
    Examining the Impact of Heated Yoga on Mindfulness and Rumination
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 1, 2023 (Anticipated)
    Primary Completion Date
    September 1, 2026 (Anticipated)
    Study Completion Date
    December 1, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Massachusetts General Hospital
    Collaborators
    Tiny Blue Dot Foundation

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Rumination, Mindfulness

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    120 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    heated yoga
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    non-heated yoga
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    heated health education
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    non-heated health education
    Arm Type
    Active Comparator
    Arm Description
    Same HEC classes as above but not in a heated dome.
    Intervention Type
    Behavioral
    Intervention Name(s)
    heated yoga
    Intervention Description
    heated yoga described in arm/group description
    Intervention Type
    Behavioral
    Intervention Name(s)
    non-heated yoga
    Intervention Description
    non-heated yoga described in arm/group description
    Intervention Type
    Behavioral
    Intervention Name(s)
    heated health education
    Intervention Description
    heated health education described in arm/group description
    Intervention Type
    Behavioral
    Intervention Name(s)
    non-heated health education
    Intervention Description
    non-heated health education described in arm/group description
    Primary Outcome Measure Information:
    Title
    Ruminative Responses Scale (RRS)
    Description
    This measure is a 22-item questionnaire, commonly used to assess rumination.
    Time Frame
    Weeks 0, 8, and 20
    Title
    The Five Facet Mindfulness Questionnaire (FFMQ-15)(33)
    Description
    A self-report instrument that measures mindfulness; derived from factor analytic study of five independent mindfulness questionnaires.
    Time Frame
    Weeks 0, 8, and 20
    Secondary Outcome Measure Information:
    Title
    Patient Health Questionnaire-9 (PHQ-9)
    Description
    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.
    Time Frame
    Weeks 0, 8, and 20
    Title
    The World Health Organization-5 Well-Being Index (WHO-5)
    Description
    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.
    Time Frame
    Weeks 0, 8, and 20
    Title
    PROMIS-29
    Description
    This measure has seven health domains (physical function, fatigue, pain interference, depressive symptoms, anxiety, social functioning, sleep disturbance) using four items per domain.
    Time Frame
    Weeks 0, 8, and 20

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: adults (≥18 years old) at least moderate difficulty with rumination at study entry (RRS score > 50) provide informed consent are able to read and understand English Exclusion Criteria: are older adults (> 65 years old) have had a bone fracture or joint surgery in the past 6 months are unable to walk 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 are already engaged in yoga practice on a weekly basis 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 are currently manic (Altman Self-Rating Mania Scale score ≥ 6(30)) are on medications that make dehydration more likely (e.g., stimulants, lithium) are unable to setup, make space for, or stay in the inflatable dome for 90-minute intervention sessions do not own a device that is able to complete the study procedures (e.g., online assessments, video conferencing for classes)
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Maren Nyer, PhD
    Phone
    617-726-8895
    Email
    mnyer@mgh.harvard.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Louisa Sylvia, PhD
    Phone
    617-726-5855
    Email
    lsylvia2@mgh.harvard.edu

    12. IPD Sharing Statement

    Learn more about this trial

    Examining the Impact of Heated Yoga on Mindfulness and Rumination

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