Skip to main content
OpenTrials
Completed

NCT Number: NCT02607514

Hyperthermic Yoga for Depressive Symptoms

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Depression Behavior Behavioral Symptoms Depressive Disorder Depressive Disorder, Major Major Depressive Disorder Mental Disorders Mood Disorders

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Depression Clinical and Research Program

Boston, Massachusetts, 02114, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • 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)

Exclusion criteria

  • 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
  • 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

Treatment and study plan

hyperthermic yoga

Behavioral

heated yoga, 90-minutes

Other names: Bikram Yoga

Primary outcomes

  1. Depressive Symptoms as Measured by the Inventory of Depressive Symptomatology - Clinician Rated (IDS-CR)

    Time frame: 8-week primary endpoint

    Inventory of Depressive Symptomatology - Clinician Rated. Scale range: 0-84 (higher = greater depressive symptoms)

  2. Feasibility and Tolerability Measured by Percent of the Yoga Group Who Complete a Week 8 Assessment

    Time frame: 8-week primary end point

    Measured by percent of the yoga group who complete a week 8 assessment

  3. Acceptability as Measured by the Acceptability Interview Completed at 8-week Endpoint or Early Termination

    Time frame: 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 outcomes

  1. Quality of Life as Measured by the Quality of Life Satisfaction Questionnaire-Short Form (Q-LES-Q-SF) Over 8 Weeks.

    Time frame: 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

  2. General Health as Measured by the Medical Outcomes Study 36-item Short-form Survey (SF-36)

    Time frame: 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.

  3. 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.

    Time frame: 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.

  4. Perceived Stress as Measured by the Perceived Stress Scale (PSS) Over 8 Weeks.

    Time frame: 8 weeks

    The Perceived Stress Scale (PSS): Measures perceived level of stress. Scale range: 0-40 (higher = more perceived stress)

  5. Anxiety as Measured by the Spielberger State-Trait Anxiety Inventory (STAI), State, Over 8 Weeks.

    Time frame: 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.

  6. 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.

    Time frame: 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.

  7. Long Term Effects of Heated Yoga Intervention as Measured by All Primary and Secondary Outcomes After 1 Month Post-intervention.

    Time frame: one month post intervention

    see all primary and secondary outcome measures listed here.

  8. Anxiety as Measured by the Spielberger State-Trait Anxiety Inventory (STAI), Trait, Over 8 Weeks.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

Registry information

Official study title

Mechanisms of Hyperthermic Yoga for the Treatment of Depression

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Nov 18, 2015
Registry last updated
Nov 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.