Clinical trial NCT01797887: Ayurvedic Versus Conventional Counseling in Mothers With Burnout-Syndrome
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
Overall status: COMPLETED
Phase: NA
Conditions: Burnout-Syndrome
Keywords: Burnout-Syndrome
Ayurveda
Ayurvedic
Traditional Indian Medicine
CAM
Whole Medical System
Diet and Lifestyle Counseling
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: Karl and Veronica Carstens Foundation
name: European Association for Ayurveda Therapists, Germany (VEAT)
First posted: 2013-02-25
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Maslach-Burnout-Inventory (MBI)
timeFrame: 3 month
Secondary outcomes:
measure: Maslach-Burnout-Inventory (MBI)
timeFrame: 6 month
measure: Cohen Perceived Stress Scale (CPSS)
timeFrame: 3 and 6 month
measure: Hospital Anxiety and Depression Scale (HADS-D)
timeFrame: 3 and 6 month
measure: SF-36
timeFrame: 3 and 6 month
measure: Aspects of Spirituality (ASP)
timeFrame: 3 and 6 month
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 3 and 6 month
Other outcomes:
measure: Qualitative Interviews
timeFrame: 6 month
Locations:
city: Berlin
country: Germany
facility: Immanuel Hospital Berlin
Study officials:
affiliation: Charité Medical University Berlin, Germany
name: Andreas Michalsen, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.