Depression, Major Depressive Disorder
Conditions
Brief summary
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.
Interventions
BEHAVIORALhyperthermic yoga
heated yoga, 90-minutes
Sponsors
Massachusetts General Hospital
National Center for Complementary and Integrative Health (NCCIH)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
1. Adults ages 18-60 2. English language proficiency 3. Ability to provide informed consent 4. Score of \>23 on the Inventory of Depressive Symptomatology - Clinician Rated (IDS-CR) 5. Able and willing to attend two 90-minute hyperthermic yoga sessions per week 6. Willingness to keep existing exercise regimen (even if that is sedentary) stable over study course 7. Women of childbearing potential must use an acceptable form of birth control 8. Membership to the Bikram Yoga Boston and Bikram Yoga Cambridge studios via studio website "Interested in research" option through a centralized portal (this will remain central until January 1, 2017) 9. Willingness to adhere to hydration requirements (i.e., an additional four 8 oz servings of water pre- and post-yoga classes)
Exclusion criteria
1. Pregnancy or planned pregnancy during study 2. History of psychiatric hospitalization within the past year 3. Active suicidal intent within the past year ("yes" on item 4 or 5 on the Columbia-Suicide Severity Rating Scale) 4. History of neurologic disorders that could interfere in study participation 5. History of bipolar disorder, psychotic disorders, eating disorders, and/or substance abuse or dependence (within the last year), as per the Mini-International Neuropsychiatric Interview (MINI) 6. Psychotropic medication use that has been stable for \<3 months 7. Use of stimulant medications or diet pills during the study, or any pre-workout powders or liquids designed to provide excessive energy 8. Positive urine toxicology screen due to illicit drug use or other exclusionary medications. (Potential false positives will be addressed on a case-by-case basis at the discretion of the investigator) 9. Active conditions which may also cause depressive symptoms (e.g. epilepsy, hypothyroidism) 10. Medical conditions that may make participation unsafe (e.g., diabetes \[I \& II\], cardiovascular disease, hypertension \[\>140 systolic and/or \>90 diastolic\], hypotension \[\<90 systolic and/or \<60 diastolic, during screening\], orthostatic hypotension \[systolic drop of 20 points or 10 point diastolic or heart rate increase by 10\], autoimmune disorders, malignancy, or autonomic dysfunction) 11. \> 6 one hour classes of meditation or other mind-body disciplines (e.g., Tai chi or yoga) within the last 6 months 12. Current individual or group psychotherapy established for \<3 months 13. A subject who in the opinion of the Principal Investigator would not be able to safely complete the study or would jeopardize study integrity 14. History of heat intolerance or heat stroke 15. Unsafe cardiac status as defined by abnormal ECG reading at screening visit as determined by medical monitor, study doctor, or subject's PCP or cardiologist
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Depressive Symptoms as Measured by the Inventory of Depressive Symptomatology - Clinician Rated (IDS-CR) | 8-week primary endpoint | Inventory of Depressive Symptomatology - Clinician Rated. Scale range: 0-84 (higher = greater depressive symptoms) |
| Feasibility and Tolerability Measured by Percent of the Yoga Group Who Complete a Week 8 Assessment | 8-week primary end point | Measured by percent of the yoga group who complete a week 8 assessment |
| Acceptability as Measured by the Acceptability Interview Completed at 8-week Endpoint or Early Termination | at the end of 8-weeks 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? |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life as Measured by the Quality of Life Satisfaction Questionnaire-Short Form (Q-LES-Q-SF) Over 8 Weeks. | 8-weeks end point | Quality of Life Satisfaction Questionnaire-Short Form (Q-LES-Q-SF) Range 0-70 with higher scores indicating greater life satisfaction and enjoyment |
| General Health as Measured by the Medical Outcomes Study 36-item Short-form Survey (SF-36) | 8 weeks | 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. |
| 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. | 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. |
| Perceived Stress as Measured by the Perceived Stress Scale (PSS) Over 8 Weeks. | 8 weeks | The Perceived Stress Scale (PSS): Measures perceived level of stress. Scale range: 0-40 (higher = more perceived stress) |
| Anxiety as Measured by the Spielberger State-Trait Anxiety Inventory (STAI), State, Over 8 Weeks. | 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. |
| 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. | 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. |
| Long Term Effects of Heated Yoga Intervention -- IDS-CR | one month post intervention | Inventory of Depressive Symptomatology - Clinician Rated. Scale range: 0-84 (higher = greater depressive symptoms) |
| Long Term Effects of Heated Yoga Intervention -- PSQI | baseline to 1-month follow-up | 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. |
| Long Term Effects of Heated Yoga Intervention -- QLESQ | baseline to 1-month follow-up | Quality of Life Satisfaction Questionnaire-Short Form (Q-LES-Q-SF) Range 0-70 with higher scores indicating greater life satisfaction and enjoyment |
| Long Term Effects of Heated Yoga Intervention -- SF-36 PF | baseline to 1-month follow-up | 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. |
| Long Term Effects of Heated Yoga Intervention -- SF-36 GH | baseline to 1-month follow-up | 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. |
| Long Term Effects of Heated Yoga Intervention -- PSS | baseline to 1-month follow-up | The Perceived Stress Scale (PSS): Measures perceived level of stress. Scale range: 0-40 (higher = more perceived stress) |
| Long Term Effects of Heated Yoga Intervention -- STAI State | baseline to 1-month follow-up | 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. |
| Long Term Effects of Heated Yoga Intervention -- STAI Trait | baseline to 1-month follow-up | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Immediate Yoga Arm participants will immediately start the 8-week hyperthermic yoga intervention
hyperthermic yoga: heated yoga, 90-minutes | 33 |
| Delayed Yoga Arm participants will wait 8 weeks to start the 8-week hyperthermic yoga intervention
hyperthermic yoga: heated yoga, 90-minutes | 32 |
| Total | 65 |
Baseline characteristics
| Characteristic | Delayed Yoga Arm | Immediate Yoga Arm | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 32 Participants | 33 Participants | 65 Participants |
| Age, Continuous | 33.12 years STANDARD_DEVIATION 11.93 | 32.3 years STANDARD_DEVIATION 11.65 | 32.71 years STANDARD_DEVIATION 11.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 2 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 27 Participants | 31 Participants | 58 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| HAMD-17 | 20.78 units on a scale STANDARD_DEVIATION 4.02 | 22.21 units on a scale STANDARD_DEVIATION 5.42 | 21.51 units on a scale STANDARD_DEVIATION 4.8 |
| IDS-CR | 34.38 units on a scale STANDARD_DEVIATION 6.68 | 36.86 units on a scale STANDARD_DEVIATION 8.8 | 35.63 units on a scale STANDARD_DEVIATION 7.87 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 4 Participants | 8 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 3 Participants | 6 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) White | 21 Participants | 24 Participants | 45 Participants |
| Region of Enrollment United States | 32 Participants | 33 Participants | 65 Participants |
| Sex: Female, Male Female | 28 Participants | 25 Participants | 53 Participants |
| Sex: Female, Male Male | 4 Participants | 8 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 33 | 0 / 32 |
| other Total, other adverse events | 3 / 33 | 1 / 32 |
| serious Total, serious adverse events | 0 / 33 | 0 / 32 |
Outcome results
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?
Time frame: at the end of 8-weeks or early termination.
Population: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Immediate Yoga Arm | Acceptability as Measured by the Acceptability Interview Completed at 8-week Endpoint or Early Termination | Enjoyment of yoga | 7.17 likert scale units | Standard Deviation 2.28 |
| Immediate Yoga Arm | Acceptability as Measured by the Acceptability Interview Completed at 8-week Endpoint or Early Termination | Enjoyment of aftereffects of yoga | 8.33 likert scale units | Standard Deviation 1.74 |
| Immediate Yoga Arm | Acceptability as Measured by the Acceptability Interview Completed at 8-week Endpoint or Early Termination | Reasonable time commitment | 6.90 likert scale units | Standard Deviation 2.38 |
| Delayed Yoga Arm | Acceptability as Measured by the Acceptability Interview Completed at 8-week Endpoint or Early Termination | Enjoyment of yoga | 7.52 likert scale units | Standard Deviation 1.99 |
| Delayed Yoga Arm | Acceptability as Measured by the Acceptability Interview Completed at 8-week Endpoint or Early Termination | Enjoyment of aftereffects of yoga | 8.59 likert scale units | Standard Deviation 1.67 |
| Delayed Yoga Arm | Acceptability as Measured by the Acceptability Interview Completed at 8-week Endpoint or Early Termination | Reasonable time commitment | 7 likert scale units | Standard Deviation 2 |
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)
Time frame: 8-week primary endpoint
Population: The number of baseline participants reported is the sample that we analyzed in our a priori Modified Intent-to-Treat (MITT) primary analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Yoga Arm | Depressive Symptoms as Measured by the Inventory of Depressive Symptomatology - Clinician Rated (IDS-CR) | 17.93 units on a scale | Standard Deviation 12.7 |
| Delayed Yoga Arm | Depressive Symptoms as Measured by the Inventory of Depressive Symptomatology - Clinician Rated (IDS-CR) | 29.63 units on a scale | Standard Deviation 9.58 |
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
Time frame: 8-week primary end point
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Immediate Yoga Arm | Feasibility and Tolerability Measured by Percent of the Yoga Group Who Complete a Week 8 Assessment | 27 Participants |
| Delayed Yoga Arm | Feasibility and Tolerability Measured by Percent of the Yoga Group Who Complete a Week 8 Assessment | 32 Participants |
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.
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Yoga Arm | Anxiety as Measured by the Spielberger State-Trait Anxiety Inventory (STAI), State, Over 8 Weeks. | 40.69 units on a scale | Standard Deviation 10.74 |
| Delayed Yoga Arm | Anxiety as Measured by the Spielberger State-Trait Anxiety Inventory (STAI), State, Over 8 Weeks. | 48.43 units on a scale | Standard Deviation 9.66 |
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.
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Yoga Arm | Anxiety as Measured by the Spielberger State-Trait Anxiety Inventory (STAI), Trait, Over 8 Weeks. | 46.70 units on a scale | Standard Deviation 11.8 |
| Delayed Yoga Arm | Anxiety as Measured by the Spielberger State-Trait Anxiety Inventory (STAI), Trait, Over 8 Weeks. | 54.1 units on a scale | Standard Deviation 8.25 |
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.
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Yoga Arm | General Health as Measured by the Medical Outcomes Study 36-item Short-form Survey (SF-36) | 61.67 units on a scale | Standard Deviation 23.15 |
| Delayed Yoga Arm | General Health as Measured by the Medical Outcomes Study 36-item Short-form Survey (SF-36) | 53.5 units on a scale | Standard Deviation 18.72 |
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.
Time frame: one month post intervention
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)
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Yoga Arm | Perceived Stress as Measured by the Perceived Stress Scale (PSS) Over 8 Weeks. | 17.42 units on a scale | Standard Deviation 8.22 |
| Delayed Yoga Arm | Perceived Stress as Measured by the Perceived Stress Scale (PSS) Over 8 Weeks. | 22.33 units on a scale | Standard Deviation 5.84 |
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.
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Yoga Arm | 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. | 47.62 units on a scale | Standard Deviation 10 |
| Delayed Yoga Arm | 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. | 53.33 units on a scale | Standard Deviation 16 |
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
Time frame: 8-weeks end point
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Yoga Arm | Quality of Life as Measured by the Quality of Life Satisfaction Questionnaire-Short Form (Q-LES-Q-SF) Over 8 Weeks. | 51.33 units on a scale | Standard Deviation 7.9 |
| Delayed Yoga Arm | Quality of Life as Measured by the Quality of Life Satisfaction Questionnaire-Short Form (Q-LES-Q-SF) Over 8 Weeks. | 41.34 units on a scale | Standard Deviation 8.24 |
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.
Time frame: 8-weeks