Hyperthermic Yoga for Depressive Symptoms

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02607514
• Date of registration: 12/11/2015
• Prospective Registration: Yes
• Primary sponsor: Massachusetts General Hospital
• Public title: Hyperthermic Yoga for Depressive Symptoms
• Scientific title: Mechanisms of Hyperthermic Yoga for the Treatment of Depression
• Date of first enrolment: February 20, 2017
• Target sample size: 80
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02607514
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).
• Phase: N/A

Countries of recruitment

United States

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 60 Years
Gender: All

Health Condition(s) or Problem(s) studied

Major Depressive Disorder

Depression

Intervention(s)

Behavioral: hyperthermic yoga

Primary Outcome(s)

Feasibility and tolerability measured by percent of the yoga group who complete a week 8 assessment [Time Frame: 8-week primary end point]

Depressive symptoms as measured by the Inventory of Depressive Symptomatology - Clinician Rated (IDS-CR) [Time Frame: 8-week primary endpoint]

Secondary ID(s)

2016P000704

Source(s) of Monetary Support

Please refer to primary and secondary sponsors