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Trial record 29 of 2665 for:    "Depressive Disorder" [DISEASE] AND depressive symptoms

Hyperthermic Yoga for Depressive Symptoms

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ClinicalTrials.gov Identifier: NCT02607514
Recruitment Status : Recruiting
First Posted : November 18, 2015
Last Update Posted : January 11, 2019
Sponsor:
Information provided by (Responsible Party):
Maren Nyer, Massachusetts General Hospital

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

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Primary Completion Date : September 30, 2019
Estimated Study Completion Date : March 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fever

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




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



Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02607514


Contacts
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Contact: Maren Nyer, PhD 617-643-4897 mnyer@partners.org
Contact: David Mischoulon, MD, PhD 617-724-5198 dmischoulon@partners.org

Locations
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United States, Massachusetts
Depression Clinical and Research Program Recruiting
Boston, Massachusetts, United States, 02114
Contact: Maren Nyer, PhD    617-643-4897    mnyer@partners.org   
Contact: David Mischoulon, MD, PhD       dmischoulon@partners.org   
Principal Investigator: Maren Nyer, PhD         
Sponsors and Collaborators
Massachusetts General Hospital

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Responsible Party: Maren Nyer, Maren Nyer, PhD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02607514     History of Changes
Other Study ID Numbers: 2016P000704
First Posted: November 18, 2015    Key Record Dates
Last Update Posted: January 11, 2019
Last Verified: January 2019

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

Additional relevant MeSH terms:
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Depression
Depressive Disorder
Depressive Disorder, Major
Fever
Behavioral Symptoms
Mood Disorders
Mental Disorders
Body Temperature Changes
Signs and Symptoms