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| ID | Type | Description | Link |
|---|---|---|---|
| 5K23AT008043-05 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
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Study is a randomized controlled trial to assess the feasibility, acceptability, efficacy, and mechanisms of action of hyperthermic yoga versus a waitlist control for 80 medically healthy adults with mild to moderate depressive symptoms. The primary aim is to test the acceptability and feasibility of hyperthermic yoga as a treatment for depression. The secondary aim is to examine the effect size/efficacy of hyperthermic yoga for depressive symptoms. The tertiary aim is to explore physiological and psychological mechanisms of action.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| immediate yoga arm | Experimental | participants will immediately start the 8-week hyperthermic yoga intervention |
|
| delayed yoga arm | Other | participants will wait 8-weeks to start the 8-week hyperthermic yoga intervention |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hyperthermic yoga | Behavioral | heated yoga, 90-minutes |
|
| Measure | Description | Time Frame |
|---|---|---|
| Depressive Symptoms as Measured by the Inventory of Depressive Symptomatology - Clinician Rated (IDS-CR) | Inventory of Depressive Symptomatology - Clinician Rated. Scale range: 0-84 (higher = greater depressive symptoms) | 8-week primary endpoint |
| Feasibility and Tolerability Measured by Percent of the Yoga Group Who Complete a Week 8 Assessment | Measured by percent of the yoga group who complete a week 8 assessment | 8-week primary end point |
| Acceptability as Measured by the Acceptability Interview Completed at 8-week Endpoint or Early Termination | Acceptability Interview: A 19-question qualitative interview assesses perception of ease of participation, program likeability, and perceived benefits of the yoga program. Adapted from DeBoer et al. It was a 1-10 likert scale with 1 = lowest, 10 = highest to rate acceptability of the yoga intervention. These are the items we used: 1) how much did you enjoy the yoga itself?; 2) how much did you enjoy the aftereffects of the yoga?; and 3) how reasonable did you find the time commitment to be? | at the end of 8-weeks or early termination. |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life as Measured by the Quality of Life Satisfaction Questionnaire-Short Form (Q-LES-Q-SF) Over 8 Weeks. | Quality of Life Satisfaction Questionnaire-Short Form (Q-LES-Q-SF) Range 0-70 with higher scores indicating greater life satisfaction and enjoyment | 8-weeks end point |
| General Health as Measured by the Medical Outcomes Study 36-item Short-form Survey (SF-36) |
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Inclusion Criteria
Exclusion Criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Depression Clinical and Research Program | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41850611 | Derived | Copeland DI, Mac Giollabhui N, Foster S, Arnold C, Wu Y, Raslan H, Lind S, Nagaswami M, Streeter CC, Uebelacker L, Fisher LB, Dording C, Sylvia L, Yeung A, Cusin C, Jain FA, Pedrelli P, Mason AE, Mehta DH, Miller KK, Anthony B, Fava M, Mischoulon D, Nyer MB. Heated yoga thaws depression: A dose-response analysis from a randomized controlled trial. J Affect Disord. 2026 Jul 15;405:121647. doi: 10.1016/j.jad.2026.121647. Epub 2026 Mar 16. | |
| 37883245 | Derived |
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| ID | Title | Description |
|---|---|---|
| FG000 | Immediate Yoga Arm | participants will immediately start the 8-week hyperthermic yoga intervention hyperthermic yoga: heated yoga, 90-minutes |
| FG001 | Delayed Yoga Arm | participants will wait 8 weeks to start the 8-week hyperthermic yoga intervention hyperthermic yoga: heated yoga, 90-minutes |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The number of baseline participants reported is the sample that we analyzed in our a priori Modified Intent-to-Treat (MITT) primary analysis. A modified intent-to-treat (MITT) approach was used. Analyses only included participants who completed at least one assessment following their initial baseline visit; yoga participants were only included if they completed at least one heated yoga class and subsequent assessment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Immediate Yoga Arm | participants will immediately start the 8-week hyperthermic yoga intervention hyperthermic yoga: heated yoga, 90-minutes |
| BG001 | Delayed Yoga Arm | participants will wait 8 weeks to start the 8-week hyperthermic yoga intervention hyperthermic yoga: heated yoga, 90-minutes |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Depressive Symptoms as Measured by the Inventory of Depressive Symptomatology - Clinician Rated (IDS-CR) | Inventory of Depressive Symptomatology - Clinician Rated. Scale range: 0-84 (higher = greater depressive symptoms) | The number of baseline participants reported is the sample that we analyzed in our a priori Modified Intent-to-Treat (MITT) primary analysis. | Posted | Mean | Standard Deviation | units on a scale | 8-week primary endpoint |
|
8 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Immediate Yoga Arm | participants will immediately start the 8-week hyperthermic yoga intervention hyperthermic yoga: heated yoga, 90-minutes |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Maren Nyer | Massachusetts General Hospital | 6072796290 | mnyer@partners.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 24, 2020 | Apr 4, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
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Medical Outcomes Study 36-item short-form survey (SF-36): Assesses bodily pain, general health perception, vitality, social functioning, physical and emotional impediments to role functioning, mental health, and includes an overall physical component scale (PCS) and mental component scale (MCS). scores range from 0-100 with 100 being the best. |
| 8 weeks |
| Physical Functioning as Measured by the Physical Component Scale (PCS) of the Medical Outcomes Study 36-item Short-form Survey (SF-36) Over 8 Weeks. | Medical Outcomes Study 36-item short-form survey (SF-36)86: Assesses bodily pain, general health perception, vitality, social functioning, physical and emotional impediments to role functioning, mental health, and includes an overall physical component scale (PCS) and mental component scale (MCS). Scores range from 0-100 with 100 being the best. | 8 weeks |
| Perceived Stress as Measured by the Perceived Stress Scale (PSS) Over 8 Weeks. | The Perceived Stress Scale (PSS): Measures perceived level of stress. Scale range: 0-40 (higher = more perceived stress) | 8 weeks |
| Anxiety as Measured by the Spielberger State-Trait Anxiety Inventory (STAI), State, Over 8 Weeks. | Spielberger State-Trait Anxiety Inventory (STAI), State. A 40-item commonly used measure that distinguishes between state vs. trait anxiety. Ranges from 0-63 with higher scores indicating more anxiety. | 8 weeks |
| Sleep as Measured by the Pittsburg Sleep Quality Index (PSQI): A Commonly Used and Well-validated Self-rated Measure of Sleep-quality and Disturbance Over 8-weeks. | Pittsburg Sleep Quality Index (PSQI): A commonly used and well-validated self-rated measure of sleep-quality and disturbance. total score ranges from 0-21 with higher score indicating worse sleep quality. | 8-weeks |
| Long Term Effects of Heated Yoga Intervention as Measured by All Primary and Secondary Outcomes After 1 Month Post-intervention. | see all primary and secondary outcome measures listed here. | one month post intervention |
| Anxiety as Measured by the Spielberger State-Trait Anxiety Inventory (STAI), Trait, Over 8 Weeks. | Spielberger State-Trait Anxiety Inventory (STAI), Trait. A 40-item commonly used measure that distinguishes between state vs. trait anxiety. Ranges from 0-63 with higher scores indicating more anxiety. | 8 weeks |
| Nyer MB, Hopkins LB, Nagaswami M, Norton R, Streeter CC, Hoeppner BB, Sorensen CEC, Uebelacker L, Koontz J, Foster S, Dording C, Giollabhui NM, Yeung A, Fisher LB, Cusin C, Jain FA, Pedrelli P, Ding GA, Mason AE, Cassano P, Mehta DH, Sauder C, Raison CL, Miller KK, Fava M, Mischoulon D. A Randomized Controlled Trial of Community-Delivered Heated Hatha Yoga for Moderate-to-Severe Depression. J Clin Psychiatry. 2023 Oct 23;84(6):22m14621. doi: 10.4088/JCP.22m14621. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| IDS-CR | Inventory of Depressive Symptoms - Clinician Rated. | Mean | Standard Deviation | units on a scale |
|
| HAMD-17 | Hamilton Depression Rating Scale - 17, range 0-52 (higher is more severe depressive symptoms). | Mean | Standard Deviation | units on a scale |
|
|
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| Primary | Feasibility and Tolerability Measured by Percent of the Yoga Group Who Complete a Week 8 Assessment | Measured by percent of the yoga group who complete a week 8 assessment | Posted | Count of Participants | Participants | 8-week primary end point |
|
|
|
| Primary | Acceptability as Measured by the Acceptability Interview Completed at 8-week Endpoint or Early Termination | Acceptability Interview: A 19-question qualitative interview assesses perception of ease of participation, program likeability, and perceived benefits of the yoga program. Adapted from DeBoer et al. It was a 1-10 likert scale with 1 = lowest, 10 = highest to rate acceptability of the yoga intervention. These are the items we used: 1) how much did you enjoy the yoga itself?; 2) how much did you enjoy the aftereffects of the yoga?; and 3) how reasonable did you find the time commitment to be? | we analyzed participants who finished the trial in the immediate yoga arm, delayed yoga arm, or terminated early from the intervention. *we only published and analyzed results from the immediate yoga arm | Posted | Mean | Standard Deviation | likert scale units | at the end of 8-weeks or early termination. |
|
|
|
| Secondary | Quality of Life as Measured by the Quality of Life Satisfaction Questionnaire-Short Form (Q-LES-Q-SF) Over 8 Weeks. | Quality of Life Satisfaction Questionnaire-Short Form (Q-LES-Q-SF) Range 0-70 with higher scores indicating greater life satisfaction and enjoyment | Posted | Mean | Standard Deviation | units on a scale | 8-weeks end point |
|
|
|
| Secondary | General Health as Measured by the Medical Outcomes Study 36-item Short-form Survey (SF-36) | Medical Outcomes Study 36-item short-form survey (SF-36): Assesses bodily pain, general health perception, vitality, social functioning, physical and emotional impediments to role functioning, mental health, and includes an overall physical component scale (PCS) and mental component scale (MCS). scores range from 0-100 with 100 being the best. | Posted | Mean | Standard Deviation | units on a scale | 8 weeks |
|
|
|
| Secondary | Physical Functioning as Measured by the Physical Component Scale (PCS) of the Medical Outcomes Study 36-item Short-form Survey (SF-36) Over 8 Weeks. | Medical Outcomes Study 36-item short-form survey (SF-36)86: Assesses bodily pain, general health perception, vitality, social functioning, physical and emotional impediments to role functioning, mental health, and includes an overall physical component scale (PCS) and mental component scale (MCS). Scores range from 0-100 with 100 being the best. | Posted | Mean | Standard Deviation | units on a scale | 8 weeks |
|
|
|
| Secondary | Perceived Stress as Measured by the Perceived Stress Scale (PSS) Over 8 Weeks. | The Perceived Stress Scale (PSS): Measures perceived level of stress. Scale range: 0-40 (higher = more perceived stress) | Posted | Mean | Standard Deviation | units on a scale | 8 weeks |
|
|
|
| Secondary | Anxiety as Measured by the Spielberger State-Trait Anxiety Inventory (STAI), State, Over 8 Weeks. | Spielberger State-Trait Anxiety Inventory (STAI), State. A 40-item commonly used measure that distinguishes between state vs. trait anxiety. Ranges from 0-63 with higher scores indicating more anxiety. | Posted | Mean | Standard Deviation | units on a scale | 8 weeks |
|
|
|
| Secondary | Sleep as Measured by the Pittsburg Sleep Quality Index (PSQI): A Commonly Used and Well-validated Self-rated Measure of Sleep-quality and Disturbance Over 8-weeks. | Pittsburg Sleep Quality Index (PSQI): A commonly used and well-validated self-rated measure of sleep-quality and disturbance. total score ranges from 0-21 with higher score indicating worse sleep quality. | Not Posted | Dec 2026 | 8-weeks | Participants |
| Secondary | Long Term Effects of Heated Yoga Intervention as Measured by All Primary and Secondary Outcomes After 1 Month Post-intervention. | see all primary and secondary outcome measures listed here. | Not Posted | Dec 2025 | one month post intervention | Participants |
| Secondary | Anxiety as Measured by the Spielberger State-Trait Anxiety Inventory (STAI), Trait, Over 8 Weeks. | Spielberger State-Trait Anxiety Inventory (STAI), Trait. A 40-item commonly used measure that distinguishes between state vs. trait anxiety. Ranges from 0-63 with higher scores indicating more anxiety. | Posted | Mean | Standard Deviation | units on a scale | 8 weeks |
|
|
|
| 0 |
| 33 |
| 0 |
| 33 |
| 3 |
| 33 |
| EG001 | Delayed Yoga Arm | participants will wait 8-weeks to start the 8-week hyperthermic yoga intervention hyperthermic yoga: heated yoga, 90-minutes | 0 | 32 | 0 | 32 | 1 | 32 |
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| D001523 |
| Mental Disorders |
| Reasonable time commitment |
|