Sudarshan Kriya Yoga and Cardiac Autonomic Control in Patients With Anxiety-Depression Disorders
Primary Purpose
Anxiety, Depression
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
SKY therapy
usual drug therapy
Sponsored by
About this trial
This is an interventional treatment trial for Anxiety
Eligibility Criteria
Inclusion Criteria:
- diagnosis of anxiety-depression disorder
Exclusion Criteria:
- absence of sinus rhythm on ECG
- absence of any cardiovascular and metabolic disorder
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Sky
control
Arm Description
Sky treatment foe 15 days
standard medical therapy
Outcomes
Primary Outcome Measures
Changes in autonomic control
Parameter derived from heart rate variability: LF/HF (marker of sympatho-vagal balance)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02828072
Brief Title
Sudarshan Kriya Yoga and Cardiac Autonomic Control in Patients With Anxiety-Depression Disorders
Official Title
Effects of Sudarshan Kriya Yoga on Cardiac Autonomic Control and Anxiety/Depression Levels in Patients Affected by Anxiety-Depression Disorders
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
March 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Milan
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The effects of Sudarshan Kriya Yoga (SKY) on autonomic function in patients with anxiety-depression disorders is unknown. Thus, the authors will investigate cardiac autonomic control in a population of patients with anxiety-depression disorders which will undergo a specific SKY treatment.
Detailed Description
Several studies have demonstrated that adjuvant therapies as exercise and breathing training are effective in improving cardiac autonomic control (CAC) in patients with affective spectrum disorders. However, the effects of Sudarshan Kriya Yoga (SKY) on autonomic function in this population is unknown. To test the hypothesis that SKY training improves CAC, cardiorespiratory coupling and adaptive response of sympatho-vagal balance to orthostatic changes were evaluated in patients with anxiety and/or depression disorders.
The authors will enroll patients with a diagnosis of anxiety and/or depression disorders (DSM-IV) and they will divide them in two groups: 1) conventional therapy (Control) and 2) conventional therapy associated with SKY (Treatment) for 15 days. Anxiety and depression levels will be determined using quantitative questionnaires. For the assessment of CAC and cardiorespiratory coupling, cardiorespiratory traces will be analyzed using monovariate and bivariate autoregressive spectral analysis, respectively.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Depression
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Non-Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sky
Arm Type
Experimental
Arm Description
Sky treatment foe 15 days
Arm Title
control
Arm Type
Sham Comparator
Arm Description
standard medical therapy
Intervention Type
Other
Intervention Name(s)
SKY therapy
Intervention Description
slow breathing
Intervention Type
Drug
Intervention Name(s)
usual drug therapy
Primary Outcome Measure Information:
Title
Changes in autonomic control
Description
Parameter derived from heart rate variability: LF/HF (marker of sympatho-vagal balance)
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
diagnosis of anxiety-depression disorder
Exclusion Criteria:
absence of sinus rhythm on ECG
absence of any cardiovascular and metabolic disorder
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
28285240
Citation
Toschi-Dias E, Tobaldini E, Solbiati M, Costantino G, Sanlorenzo R, Doria S, Irtelli F, Mencacci C, Montano N. Sudarshan Kriya Yoga improves cardiac autonomic control in patients with anxiety-depression disorders. J Affect Disord. 2017 May;214:74-80. doi: 10.1016/j.jad.2017.03.017. Epub 2017 Mar 7.
Results Reference
derived
Learn more about this trial
Sudarshan Kriya Yoga and Cardiac Autonomic Control in Patients With Anxiety-Depression Disorders
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