Ayurvedic Versus Conventional Counseling in Mothers With Burnout-Syndrome (VEDA)

December 22, 2014 updated by: Andreas Michalsen, Charite University, Berlin, Germany

Diet and Lifestyle Modification in Mothers With Burnout-Syndrome: Ayurvedic Versus Conventional Standard Counseling - A Randomized Controlled Clinical Pilot Study

Aim of this study is to evaluate the effectiveness of Ayurvedic diet and lifestyle counseling compared to conventional standard diet and lifestyle counseling in outpatient mothers with burnout-syndrome.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Ayurveda is a traditional Indian medicine: as a whole medical system it consists of diagnostic procedures and complex treatments. Ayurveda-treatment is based on Ayurvedic diagnosis and has a special focus on lifestyle and nutritional counseling, based on the individual constitution of the patient. Ayurvedic counseling can easily be followed by the patients in their day-to-day life and is an inexpensive way of self-care. In Ayurveda it is often used for the treatment of burnout-syndrome. However, no systematic data is available on its effectiveness in comparison to conventional standard diet and lifestyle counseling. The aim of this study is to evaluate the effectiveness of Ayurvedic diet and lifestyle counseling compared to conventional standard diet and lifestyle counseling in outpatient mothers with burnout-syndrome.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 14109
        • Immanuel Hospital Berlin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • signed informed consent
  • age between 18 and 50
  • mother of ≥ 1 child ≤ 12 years of age
  • job, education or studies ≥ 20 hours per week
  • subjective feeling of physical and mental exhaustion since ≥ 3 month
  • ≥ 18 points in the MBI Subscale "emotional exhaustion" at screening

Exclusion Criteria:

  • change of psychotropic drug medication ≤ 6 weeks before inclusion
  • pregnancy or breastfeeding
  • pre-diagnosed major depression
  • serious chronic co-morbidity (e.g. CHF NYHA IV)
  • serious acute somatic health conditions
  • intake of opiods
  • simultaneous participation in other trials
  • praticipation in other trials during ≤ 6 month before inclusion

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Ayurveda
Ayurveda Diet and Lifestyle Counseling
Behavioral: Diet and Lifestyle Counseling
Diet and Lifestyle Counseling
ACTIVE_COMPARATOR: Conventional
Standard Conventional Diet and Lifestyle Counseling
Behavioral: Diet and Lifestyle Counseling
Diet and Lifestyle Counseling

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Maslach-Burnout-Inventory (MBI)
Time Frame: 3 month
3 month

Secondary Outcome Measures

Outcome Measure
Time Frame
Maslach-Burnout-Inventory (MBI)
Time Frame: 6 month
6 month
Cohen Perceived Stress Scale (CPSS)
Time Frame: 3 and 6 month
3 and 6 month
Hospital Anxiety and Depression Scale (HADS-D)
Time Frame: 3 and 6 month
3 and 6 month
SF-36
Time Frame: 3 and 6 month
3 and 6 month
Aspects of Spirituality (ASP)
Time Frame: 3 and 6 month
3 and 6 month
Pittsburgh Sleep Quality Index (PSQI)
Time Frame: 3 and 6 month
3 and 6 month

Other Outcome Measures

Outcome Measure
Time Frame
Qualitative Interviews
Time Frame: 6 month
6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Collaborators

Karl and Veronica Carstens Foundation
European Association for Ayurveda Therapists, Germany (VEAT)

Investigators

  • Principal Investigator: Andreas Michalsen, MD, Charité Medical University Berlin, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (ACTUAL)

December 1, 2014

Study Completion (ACTUAL)

December 1, 2014

Study Registration Dates

First Submitted

February 21, 2013

First Submitted That Met QC Criteria

February 22, 2013

First Posted (ESTIMATE)

February 25, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

December 24, 2014

Last Update Submitted That Met QC Criteria

December 22, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VEDA-Trial

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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