Ayurvedic Versus Conventional Counseling in Mothers With Burnout-Syndrome

Burnout-Syndrome Clinical Trial

— VEDA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01797887
• Other study ID #: VEDA-Trial
• Status: Completed
• Phase: N/A
• First received: February 21, 2013
• Last updated: December 22, 2014
• Start date: May 2013
• Est. completion date: December 2014

Study information

• Verified date: December 2014
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Burnout-Syndrome
• Syndrome

Intervention

Behavioral:
• Diet and Lifestyle Counseling
Diet and Lifestyle Counseling

Locations

Country	Name	City	State
Germany	Immanuel Hospital Berlin	Berlin

Sponsors (3)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany	European Association for Ayurveda Therapists, Germany (VEAT), Karl and Veronica Carstens Foundation

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Qualitative Interviews		6 month	No
Primary	Maslach-Burnout-Inventory (MBI)		3 month	No
Secondary	Maslach-Burnout-Inventory (MBI)		6 month	No
Secondary	Cohen Perceived Stress Scale (CPSS)		3 and 6 month	No
Secondary	Hospital Anxiety and Depression Scale (HADS-D)		3 and 6 month	No
Secondary	SF-36		3 and 6 month	No
Secondary	Aspects of Spirituality (ASP)		3 and 6 month	No
Secondary	Pittsburgh Sleep Quality Index (PSQI)		3 and 6 month	No

External Links

•   Cahrité Medical University Berlin, Germany
•   Immanuel Hospital Berlin, Germany