Hyperthermic Yoga for Depressive Symptoms

• ClinicalTrials.gov Identifier: NCT02607514
• Recruitment Status: Completed
• First Posted: November 18, 2015
• Last Update Posted: April 24, 2020
• Sponsor: Massachusetts General Hospital
• Information provided by (Responsible Party): Maren Nyer, Massachusetts General Hospital

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Depression; Major Depressive Disorder	Behavioral: hyperthermic yoga	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Mechanisms of Hyperthermic Yoga for the Treatment of Depression
• Actual Study Start Date: February 20, 2017
• Actual Primary Completion Date: December 19, 2019
• Actual Study Completion Date: December 19, 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: immediate yoga arm; participants will immediately start the 8-week hyperthermic yoga intervention	Behavioral: hyperthermic yoga; heated yoga, 90-minutes; Other Name: Bikram Yoga
delayed yoga arm; participants will wait 8-weeks to start the 8-week hyperthermic yoga intervention	Behavioral: hyperthermic yoga; heated yoga, 90-minutes; Other Name: Bikram Yoga

Outcome Measures

Primary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 60 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Massachusetts

Depression Clinical and Research Program

Boston, Massachusetts, United States, 02114

Sponsors and Collaborators

Massachusetts General Hospital

More Information

• Responsible Party: Maren Nyer, Maren Nyer, PhD, Massachusetts General Hospital
• ClinicalTrials.gov Identifier: NCT02607514
• Other Study ID Numbers: 2016P000704
• First Posted: November 18, 2015
• Last Update Posted: April 24, 2020
• Last Verified: April 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

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