Sudarshan Kriya Yoga and Cardiac Autonomic Control in Patients With Anxiety-Depression Disorders

Sponsor

University of Milan (Other)

Overall Status

Completed

CT.gov ID

NCT02828072

Collaborator

(none)

Enrollment

Arms

Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Anxiety Depression	Other: SKY therapy Drug: usual drug therapy	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Investigator)

Primary Purpose:

Treatment

Official Title:

Effects of Sudarshan Kriya Yoga on Cardiac Autonomic Control and Anxiety/Depression Levels in Patients Affected by Anxiety-Depression Disorders

Study Start Date :

Mar 1, 2011

Actual Primary Completion Date :

Sep 1, 2011

Actual Study Completion Date :

Mar 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Sky Sky treatment foe 15 days	Other: SKY therapy slow breathing
Sham Comparator: control standard medical therapy	Drug: usual drug therapy

Arm

Intervention/Treatment

Experimental: Sky

Sky treatment foe 15 days

Other: SKY therapy

slow breathing

Sham Comparator: control

standard medical therapy

Drug: usual drug therapy

Outcome Measures

Primary Outcome Measures

Changes in autonomic control [1 month]
Parameter derived from heart rate variability: LF/HF (marker of sympatho-vagal balance)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

diagnosis of anxiety-depression disorder

Exclusion Criteria:

absence of sinus rhythm on ECG
absence of any cardiovascular and metabolic disorder

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of Milan

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Eleonora Tobaldini, Doctor, University of Milan

ClinicalTrials.gov Identifier:

NCT02828072

Other Study ID Numbers:

SKY-1

First Posted:

Jul 11, 2016

Last Update Posted:

Jul 11, 2016

Last Verified:

Jul 1, 2016

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Additional relevant MeSH terms:

Depression

Depressive Disorder

Anxiety Disorders

Study Results

No Results Posted as of Jul 11, 2016