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Hyperthermic Yoga for Depressive Symptoms

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02607514
Recruitment Status : Completed
First Posted : November 18, 2015
Last Update Posted : April 24, 2020
Sponsor:
Information provided by (Responsible Party):
Maren Nyer, Massachusetts General Hospital

Tracking Information
First Submitted Date  ICMJE November 12, 2015
First Posted Date  ICMJE November 18, 2015
Last Update Posted Date April 24, 2020
Actual Study Start Date  ICMJE February 20, 2017
Actual Primary Completion Date December 19, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 21, 2016)
  • Depressive symptoms as measured by the Inventory of Depressive Symptomatology - Clinician Rated (IDS-CR) [ Time Frame: 8-week primary endpoint ]
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: November 17, 2015)
  • depressive symptoms as measured by Hamilton Depression Rating Scale (HDRS) - Clinician Administered [ Time Frame: 8-week primary endpoint ]
    Hamilton Depression Rating Scale (HDRS) - Clinician Administered
  • 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
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Hyperthermic Yoga for Depressive Symptoms
Official Title  ICMJE Mechanisms of Hyperthermic Yoga for the Treatment of Depression
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Depression
  • Major Depressive Disorder
Intervention  ICMJE Behavioral: hyperthermic yoga
heated yoga, 90-minutes
Other Name: Bikram Yoga
Study Arms  ICMJE
  • Experimental: immediate yoga arm
    participants will immediately start the 8-week hyperthermic yoga intervention
    Intervention: Behavioral: hyperthermic yoga
  • delayed yoga arm
    participants will wait 8-weeks to start the 8-week hyperthermic yoga intervention
    Intervention: Behavioral: hyperthermic yoga
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 17, 2015)
80
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 19, 2019
Actual Primary Completion Date December 19, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02607514
Other Study ID Numbers  ICMJE 2016P000704
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Maren Nyer, Massachusetts General Hospital
Study Sponsor  ICMJE Massachusetts General Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Massachusetts General Hospital
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP