Burnout-SyndromeVEDANCT01797887
Ayurvedic Versus Conventional Counseling in Mothers With Burnout-Syndrome
A study testing Diet and Lifestyle Counseling in people with Burnout-Syndrome, run by Charite University, Berlin, Germany at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Burnout-Syndrome
- What is being tested?
- Diet and Lifestyle Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- May 2013to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Burnout-Syndrome
- Being tested
- Diet and Lifestyle Counseling
- Keywords
- Burnout-Syndrome, Ayurveda, Ayurvedic, Traditional Indian Medicine, CAM, Whole Medical System, Diet and Lifestyle Counseling
- Medical subject headings
- Burnout, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diet and Lifestyle CounselingBehavioural
Diet and Lifestyle Counseling
| Study group | Role | What they receive |
|---|---|---|
| Ayurveda | Experimental | Ayurveda Diet and Lifestyle Counseling Receives: Behavioral: Diet and Lifestyle Counseling |
| Conventional | Active comparator | Standard Conventional Diet and Lifestyle Counseling Receives: Behavioral: Diet and Lifestyle Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maslach-Burnout-Inventory (MBI)
Measured: 3 month
Secondary outcomes (6)
Maslach-Burnout-Inventory (MBI)
Measured: 6 month
Cohen Perceived Stress Scale (CPSS)
Measured: 3 and 6 month
Hospital Anxiety and Depression Scale (HADS-D)
Measured: 3 and 6 month
SF-36
Measured: 3 and 6 month
Aspects of Spirituality (ASP)
Measured: 3 and 6 month
Pittsburgh Sleep Quality Index (PSQI)
Measured: 3 and 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2013 (estimated)
- Study startMay 2013
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Burnout-SyndromeStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- Karl and Veronica Carstens Foundation, European Association for Ayurveda Therapists, Germany (VEAT)
- Responsible party
- Principal investigator, Andreas Michalsen, Charite University, Berlin, Germany
- Investigators
- Andreas Michalsen, MD, Principal investigator, Charité Medical University Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01797887
- Sponsor's protocol ID
- VEDA-Trial
- Acronym
- VEDA
- Status last verified
- Dec 2014
- First submitted
- 21 Feb 2013
- Last updated
- 24 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 28917376
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diet and Lifestyle Modification in Mothers With Burnout-Syndrome: Ayurvedic Versus Conventional Standard Counseling - A Randomized Controlled Clinical Pilot Study
- ClinicalTrials.gov ID
- NCT01797887
- Acronym / sponsor ID
- VEDA / VEDA-Trial
- Conditions
- Burnout-Syndrome
- Keywords
- Burnout-Syndrome, Ayurveda, Ayurvedic, Traditional Indian Medicine, CAM, Whole Medical System, Diet and Lifestyle Counseling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- Karl and Veronica Carstens Foundation, European Association for Ayurveda Therapists, Germany (VEAT)
- Study start
- May 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 25 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ayurveda | Experimental | Behavioral: Diet and Lifestyle CounselingAyurveda Diet and Lifestyle Counseling |
| Conventional | Active comparator | Behavioral: Diet and Lifestyle CounselingStandard Conventional Diet and Lifestyle Counseling |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diet and Lifestyle CounselingDiet and Lifestyle Counseling | Behavioural | Ayurveda, Conventional |
Primary outcome
Maslach-Burnout-Inventory (MBI)
Time frame: 3 month
6 secondary outcomes
Maslach-Burnout-Inventory (MBI)
Time frame: 6 month
Cohen Perceived Stress Scale (CPSS)
Time frame: 3 and 6 month
Hospital Anxiety and Depression Scale (HADS-D)
Time frame: 3 and 6 month
SF-36
Time frame: 3 and 6 month
Aspects of Spirituality (ASP)
Time frame: 3 and 6 month
Pittsburgh Sleep Quality Index (PSQI)
Time frame: 3 and 6 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2014.
- Derived from this study: PubMed 28917376Kessler 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.
- Immanuel Hospital Berlin, GermanyLink provided by the sponsor.
- Cahrité Medical University Berlin, GermanyLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andreas Michalsen, MD principal investigator
Charité Medical University Berlin, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diet and Lifestyle Counseling in people with Burnout-Syndrome, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maslach-Burnout-Inventory (MBI) (time frame: 3 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01797887, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2014.