Hyperthermic Yoga for Depressive Symptoms
Primary Purpose
Depression, Major Depressive Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
hyperthermic yoga
Sponsored by
About this trial
This is an interventional treatment trial for Depression
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
Sites / Locations
- Depression Clinical and Research Program
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
immediate yoga arm
delayed yoga arm
Arm Description
participants will immediately start the 8-week hyperthermic yoga intervention
participants will wait 8-weeks to start the 8-week hyperthermic yoga intervention
Outcomes
Primary Outcome Measures
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
measured by percent of the yoga group who complete a week 8 assessment
Secondary Outcome Measures
Full Information
NCT ID
NCT02607514
First Posted
November 12, 2015
Last Updated
April 23, 2020
Sponsor
Massachusetts General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02607514
Brief Title
Hyperthermic Yoga for Depressive Symptoms
Official Title
Mechanisms of Hyperthermic Yoga for the Treatment of Depression
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
February 20, 2017 (Actual)
Primary Completion Date
December 19, 2019 (Actual)
Study Completion Date
December 19, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Major Depressive Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
immediate yoga arm
Arm Type
Experimental
Arm Description
participants will immediately start the 8-week hyperthermic yoga intervention
Arm Title
delayed yoga arm
Arm Type
Other
Arm Description
participants will wait 8-weeks to start the 8-week hyperthermic yoga intervention
Intervention Type
Behavioral
Intervention Name(s)
hyperthermic yoga
Other Intervention Name(s)
Bikram Yoga
Intervention Description
heated yoga, 90-minutes
Primary Outcome Measure Information:
Title
Depressive symptoms as measured by the Inventory of Depressive Symptomatology - Clinician Rated (IDS-CR)
Time Frame
8-week primary endpoint
Title
Feasibility and tolerability measured by percent of the yoga group who complete a week 8 assessment
Description
measured by percent of the yoga group who complete a week 8 assessment
Time Frame
8-week primary end point
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Depression Clinical and Research Program
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
12. IPD Sharing Statement
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Hyperthermic Yoga for Depressive Symptoms
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