Ayurvedic Versus Conventional Counseling in Mothers With Burnout-Syndrome
VEDA
Diet and Lifestyle Modification in Mothers With Burnout-Syndrome: Ayurvedic Versus Conventional Standard Counseling - A Randomized Controlled Clinical Pilot Study
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 21, 2013
CompletedFirst Posted
Study publicly available on registry
February 25, 2013
CompletedStudy Start
First participant enrolled
May 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedDecember 24, 2014
December 1, 2014
1.6 years
February 21, 2013
December 22, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Maslach-Burnout-Inventory (MBI)
3 month
Secondary Outcomes (6)
Maslach-Burnout-Inventory (MBI)
6 month
Cohen Perceived Stress Scale (CPSS)
3 and 6 month
Hospital Anxiety and Depression Scale (HADS-D)
3 and 6 month
SF-36
3 and 6 month
Aspects of Spirituality (ASP)
3 and 6 month
- +1 more secondary outcomes
Other Outcomes (1)
Qualitative Interviews
6 month
Study Arms (2)
Ayurveda
EXPERIMENTALAyurveda Diet and Lifestyle Counseling
Conventional
ACTIVE COMPARATORStandard Conventional Diet and Lifestyle Counseling
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Immanuel Hospital Berlin
Berlin, State of Berlin, 14109, Germany
Related Publications (1)
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.
PMID: 28917376DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andreas Michalsen, MD
Charité Medical University Berlin, Germany
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof. Dr. med. Andreas Michalsen
Study Record Dates
First Submitted
February 21, 2013
First Posted
February 25, 2013
Study Start
May 1, 2013
Primary Completion
December 1, 2014
Study Completion
December 1, 2014
Last Updated
December 24, 2014
Record last verified: 2014-12