Hyperthermic Yoga for Depressive Symptoms
- Conditions
- DepressionMajor Depressive Disorder
- Registration Number
- NCT02607514
- Lead Sponsor
- Massachusetts General Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria<br><br> 1. Adults ages 18-60<br><br> 2. English language proficiency<br><br> 3. Ability to provide informed consent<br><br> 4. Score of >23 on the Inventory of Depressive Symptomatology - Clinician Rated<br> (IDS-CR)<br><br> 5. Able and willing to attend two 90-minute hyperthermic yoga sessions per week<br><br> 6. Willingness to keep existing exercise regimen (even if that is sedentary) stable<br> over study course<br><br> 7. Women of childbearing potential must use an acceptable form of birth control<br><br> 8. Membership to the Bikram Yoga Boston and Bikram Yoga Cambridge studios via studio<br> website Interested in research option through a centralized portal (this will<br> remain central until January 1, 2017)<br><br> 9. Willingness to adhere to hydration requirements (i.e., an additional four 8 oz<br> servings of water pre- and post-yoga classes)<br><br>Exclusion Criteria<br><br> 1. Pregnancy or planned pregnancy during study<br><br> 2. History of psychiatric hospitalization within the past year<br><br> 3. Active suicidal intent within the past year (yes on item 4 or 5 on the<br> Columbia-Suicide Severity Rating Scale)<br><br> 4. History of neurologic disorders that could interfere in study participation<br><br> 5. History of bipolar disorder, psychotic disorders, eating disorders, and/or substance<br> abuse or dependence (within the last year), as per the Mini-International<br> Neuropsychiatric Interview (MINI)<br><br> 6. Psychotropic medication use that has been stable for <3 months<br><br> 7. Use of stimulant medications or diet pills during the study, or any pre-workout<br> powders or liquids designed to provide excessive energy<br><br> 8. Positive urine toxicology screen due to illicit drug use or other exclusionary<br> medications. (Potential false positives will be addressed on a case-by-case basis at<br> the discretion of the investigator)<br><br> 9. Active conditions which may also cause depressive symptoms (e.g. epilepsy,<br> hypothyroidism)<br><br> 10. Medical conditions that may make participation unsafe (e.g., diabetes [I & II],<br> cardiovascular disease, hypertension [>140 systolic and/or >90 diastolic],<br> hypotension [<90 systolic and/or <60 diastolic, during screening], orthostatic<br> hypotension [systolic drop of 20 points or 10 point diastolic or heart rate increase<br> by 10], autoimmune disorders, malignancy, or autonomic dysfunction)<br><br> 11. > 6 one hour classes of meditation or other mind-body disciplines (e.g., Tai chi or<br> yoga) within the last 6 months<br><br> 12. Current individual or group psychotherapy established for <3 months<br><br> 13. A subject who in the opinion of the Principal Investigator would not be able to<br> safely complete the study or would jeopardize study integrity<br><br> 14. History of heat intolerance or heat stroke<br><br> 15. Unsafe cardiac status as defined by abnormal ECG reading at screening visit as<br> determined by medical monitor, study doctor, or subject's PCP or cardiologist
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Depressive Symptoms as Measured by the Inventory of Depressive Symptomatology - Clinician Rated (IDS-CR);Feasibility and Tolerability 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
- Secondary Outcome Measures
Name Time Method Quality of Life as Measured by the Quality of Life Satisfaction Questionnaire-Short Form (Q-LES-Q-SF) Over 8 Weeks.;General Health as Measured by the Medical Outcomes Study 36-item Short-form Survey (SF-36);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.;Perceived Stress as Measured by the Perceived Stress Scale (PSS) Over 8 Weeks.;Anxiety as Measured by the Spielberger State-Trait Anxiety Inventory (STAI), State, Over 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.;Long Term Effects of Heated Yoga Intervention as Measured by All Primary and Secondary Outcomes After 1 Month Post-intervention.;Anxiety as Measured by the Spielberger State-Trait Anxiety Inventory (STAI), Trait, Over 8 Weeks.