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

Primary Purpose

Burnout-Syndrome

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Diet and Lifestyle Counseling
Sponsored by
Charite University, Berlin, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Burnout-Syndrome focused on measuring Burnout-Syndrome, Ayurveda, Ayurvedic, Traditional Indian Medicine, CAM, Whole Medical System, Diet and Lifestyle Counseling

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Immanuel Hospital Berlin

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ayurveda

Conventional

Arm Description

Ayurveda Diet and Lifestyle Counseling

Standard Conventional Diet and Lifestyle Counseling

Outcomes

Primary Outcome Measures

Maslach-Burnout-Inventory (MBI)

Secondary Outcome Measures

Maslach-Burnout-Inventory (MBI)
Cohen Perceived Stress Scale (CPSS)
Hospital Anxiety and Depression Scale (HADS-D)
SF-36
Aspects of Spirituality (ASP)
Pittsburgh Sleep Quality Index (PSQI)

Full Information

First Posted
February 21, 2013
Last Updated
December 22, 2014
Sponsor
Charite University, Berlin, Germany
Collaborators
Karl and Veronica Carstens Foundation, European Association for Ayurveda Therapists, Germany (VEAT)
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1. Study Identification

Unique Protocol Identification Number
NCT01797887
Brief Title
Ayurvedic Versus Conventional Counseling in Mothers With Burnout-Syndrome
Acronym
VEDA
Official Title
Diet and Lifestyle Modification in Mothers With Burnout-Syndrome: Ayurvedic Versus Conventional Standard Counseling - A Randomized Controlled Clinical Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charite University, Berlin, Germany
Collaborators
Karl and Veronica Carstens Foundation, European Association for Ayurveda Therapists, Germany (VEAT)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burnout-Syndrome
Keywords
Burnout-Syndrome, Ayurveda, Ayurvedic, Traditional Indian Medicine, CAM, Whole Medical System, Diet and Lifestyle Counseling

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ayurveda
Arm Type
Experimental
Arm Description
Ayurveda Diet and Lifestyle Counseling
Arm Title
Conventional
Arm Type
Active Comparator
Arm Description
Standard Conventional Diet and Lifestyle Counseling
Intervention Type
Behavioral
Intervention Name(s)
Diet and Lifestyle Counseling
Intervention Description
Diet and Lifestyle Counseling
Primary Outcome Measure Information:
Title
Maslach-Burnout-Inventory (MBI)
Time Frame
3 month
Secondary Outcome Measure Information:
Title
Maslach-Burnout-Inventory (MBI)
Time Frame
6 month
Title
Cohen Perceived Stress Scale (CPSS)
Time Frame
3 and 6 month
Title
Hospital Anxiety and Depression Scale (HADS-D)
Time Frame
3 and 6 month
Title
SF-36
Time Frame
3 and 6 month
Title
Aspects of Spirituality (ASP)
Time Frame
3 and 6 month
Title
Pittsburgh Sleep Quality Index (PSQI)
Time Frame
3 and 6 month
Other Pre-specified Outcome Measures:
Title
Qualitative Interviews
Time Frame
6 month

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreas Michalsen, MD
Organizational Affiliation
Charité Medical University Berlin, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Immanuel Hospital Berlin
City
Berlin
ZIP/Postal Code
14109
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
28917376
Citation
Kessler CS, Eisenmann C, Oberzaucher F, Forster M, Steckhan N, Meier L, Stapelfeldt E, Michalsen A, Jeitler M. Ayurvedic versus conventional dietary and lifestyle counseling for mothers with burnout-syndrome: A randomized controlled pilot study including a qualitative evaluation. Complement Ther Med. 2017 Oct;34:57-65. doi: 10.1016/j.ctim.2017.07.005. Epub 2017 Jul 16.
Results Reference
derived
Links:
URL
http://www.naturheilkunde.immanuel.de
Description
Immanuel Hospital Berlin, Germany
URL
http://www.charite.de
Description
Cahrité Medical University Berlin, Germany

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Ayurvedic Versus Conventional Counseling in Mothers With Burnout-Syndrome

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