Clinical trial NCT02607514: Hyperthermic Yoga for Depressive Symptoms
Official title: Mechanisms of Hyperthermic Yoga for the Treatment of Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Major Depressive Disorder
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2015-11-18
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Depressive Symptoms as Measured by the Inventory of Depressive Symptomatology - Clinician Rated (IDS-CR)
timeFrame: 8-week primary endpoint
measure: Feasibility and Tolerability Measured by Percent of the Yoga Group Who Complete a Week 8 Assessment
timeFrame: 8-week primary end point
measure: Acceptability as Measured by the Acceptability Interview Completed at 8-week Endpoint or Early Termination
timeFrame: at the end of 8-weeks or early termination.
Secondary outcomes:
measure: Quality of Life as Measured by the Quality of Life Satisfaction Questionnaire-Short Form (Q-LES-Q-SF) Over 8 Weeks.
timeFrame: 8-weeks end point
measure: General Health as Measured by the Medical Outcomes Study 36-item Short-form Survey (SF-36)
timeFrame: 8 weeks
measure: 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.
timeFrame: 8 weeks
measure: Perceived Stress as Measured by the Perceived Stress Scale (PSS) Over 8 Weeks.
timeFrame: 8 weeks
measure: Anxiety as Measured by the Spielberger State-Trait Anxiety Inventory (STAI), State, Over 8 Weeks.
timeFrame: 8 weeks
measure: 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.
timeFrame: 8-weeks
measure: Long Term Effects of Heated Yoga Intervention as Measured by All Primary and Secondary Outcomes After 1 Month Post-intervention.
timeFrame: one month post intervention
measure: Anxiety as Measured by the Spielberger State-Trait Anxiety Inventory (STAI), Trait, Over 8 Weeks.
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Depression Clinical and Research Program
state: Massachusetts
Study officials:
References: