DepressionNCT02607514
Hyperthermic Yoga for Depressive Symptoms
A study testing hyperthermic yoga in people with Depression and Major Depressive Disorder, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Depression, Major Depressive Disorder
- What is being tested?
- hyperthermic yoga
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Feb 2017to 19 Dec 2019
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adults ages 18-60
- English language proficiency
- Ability to provide informed consent
- Score of >23 on the Inventory of Depressive Symptomatology - Clinician Rated (IDS-CR)
- Able and willing to attend two 90-minute hyperthermic yoga sessions per week
- Willingness to keep existing exercise regimen (even if that is sedentary) stable over study course
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- Women of childbearing potential must use an acceptable form of birth control
- 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)
- Willingness to adhere to hydration requirements (i.e., an additional four 8 oz servings of water pre- and post-yoga classes)
Who cannot join
- Pregnancy or planned pregnancy during study
- History of psychiatric hospitalization within the past year
- Active suicidal intent within the past year ("yes" on item 4 or 5 on the Columbia-Suicide Severity Rating Scale)
- History of neurologic disorders that could interfere in study participation
- 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)
- Psychotropic medication use that has been stable for <3 months
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- Use of stimulant medications or diet pills during the study, or any pre-workout powders or liquids designed to provide excessive energy
- 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)
- Active conditions which may also cause depressive symptoms (e.g. epilepsy, hypothyroidism)
- 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)
- > 6 one hour classes of meditation or other mind-body disciplines (e.g., Tai chi or yoga) within the last 6 months
- Current individual or group psychotherapy established for <3 months
- A subject who in the opinion of the Principal Investigator would not be able to safely complete the study or would jeopardize study integrity
- History of heat intolerance or heat stroke
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Depression Clinical and Research Program
Boston, Massachusetts, 02114
About this study
Official title: Mechanisms of Hyperthermic Yoga for the Treatment of Depression
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.
- Conditions
- Depression, Major Depressive Disorder
- Being tested
- hyperthermic yoga
- Medical subject headings
- Depression, Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hyperthermic yogaBehavioural
Also called Bikram Yoga
heated yoga, 90-minutes
| Study group | Role | What they receive |
|---|---|---|
| immediate yoga arm | Experimental | participants will immediately start the 8-week hyperthermic yoga intervention Receives: Behavioral: hyperthermic yoga |
| delayed yoga arm | Other | participants will wait 8-weeks to start the 8-week hyperthermic yoga intervention Receives: Behavioral: hyperthermic yoga |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: 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?
Measured: at the end of 8-weeks or early termination.
Secondary outcomes (14)
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
Measured: 8-weeks end point
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.
Measured: 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.
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 8-weeks
Long Term Effects of Heated Yoga Intervention -- IDS-CR
Inventory of Depressive Symptomatology - Clinician Rated. Scale range: 0-84 (higher = greater depressive symptoms)
Measured: one month post intervention
Long Term Effects of Heated Yoga Intervention -- PSQI
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.
Measured: baseline to 1-month follow-up
Long Term Effects of Heated Yoga Intervention -- QLESQ
Quality of Life Satisfaction Questionnaire-Short Form (Q-LES-Q-SF) Range 0-70 with higher scores indicating greater life satisfaction and enjoyment
Measured: baseline to 1-month follow-up
Long Term Effects of Heated Yoga Intervention -- SF-36 PF
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.
Measured: baseline to 1-month follow-up
Long Term Effects of Heated Yoga Intervention -- SF-36 GH
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.
Measured: baseline to 1-month follow-up
Long Term Effects of Heated Yoga Intervention -- PSS
The Perceived Stress Scale (PSS): Measures perceived level of stress. Scale range: 0-40 (higher = more perceived stress)
Measured: baseline to 1-month follow-up
Long Term Effects of Heated Yoga Intervention -- STAI State
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.
Measured: baseline to 1-month follow-up
Long Term Effects of Heated Yoga Intervention -- STAI Trait
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.
Measured: baseline to 1-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2015 (estimated)
- Study start20 Feb 2017
- Primary completion19 Dec 2019
- Study completion19 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Principal investigator, Maren Nyer, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02607514
- Sponsor's protocol ID
- 2016P000704
- Other IDs
- 5K23AT008043-05
- Status last verified
- Sep 2026
- First submitted
- 12 Nov 2015
- Last updated
- 10 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 41850611Nyer 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.
PubMed 37883245