Hyperthermic Yoga for Depressive Symptoms

Study Overview
=================
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.

Official Title
-----------------
Mechanisms of Hyperthermic Yoga for the Treatment of Depression

Conditions
-----------------
Depression, Major Depressive Disorder

Intervention / Treatment
-----------------
* Behavioral: hyperthermic yoga


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: immediate yoga arm<br>participants will immediately start the 8-week hyperthermic yoga intervention | Behavioral: hyperthermic yoga<br>* heated yoga, 90-minutes<br>* Other names: Bikram Yoga;|
| Other: delayed yoga arm<br>participants will wait 8-weeks to start the 8-week hyperthermic yoga intervention | Behavioral: hyperthermic yoga<br>* heated yoga, 90-minutes<br>* Other names: Bikram Yoga;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depressive symptoms as measured by the Inventory of Depressive Symptomatology - Clinician Rated (IDS-CR) |  | 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 | 8-week primary end point |