Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000623796
Ethics application status
Approved
Date submitted
2/05/2013
Date registered
31/05/2013
Date last updated
24/06/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Mindfulness-Based Stress Reduction 'MBSR' impact on PolyCystic Ovary Syndrome 'PCOS' patients' stress levels.
Scientific title
Mindfulness-Based Stress Reduction 'MBSR' impact in PolyCystic Ovary Syndrome 'PCOS' patients stress levels: a blind randomized controlled trial in females of reproductive age.
Secondary ID [1] 281250 0
Nil
Universal Trial Number (UTN)
U1111-1134-8003
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
PolyCystic Ovary Syndrome (PCOS) 287440 0
Condition category
Condition code
Reproductive Health and Childbirth 287775 287775 0 0
Other reproductive health and childbirth disorders
Metabolic and Endocrine 287789 287789 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Mindfulness-based stress reduction program, including mindfulness breathing training exercises. It is administered on enrollment day by the main investigator. The session lasts for 20 to 30 minutes, per patient. It is administered on individual basis. The investigator advises for the daily implementation of the program in daily routine, for about 15 to 20 minutes, once, daily. There is a scheduled meeting at the end of the week of 20 to 30 minutes, when the patients report on their progress and the frequency of their practice or the changes, they may observe in the past week.
Intervention code [1] 285725 0
Treatment: Other
Comparator / control treatment
PCOS patients, who do not participate in the Mindfulness-Based Stress Reduction group. This is a two-armed, parallel group, randomized controlled study with a 1:1 allocation ratio of PCOS patients to treatment or non-treatment groups and at 8-weeks of follow-up.
Control group
Active

Outcomes
Primary outcome [1] 289486 0
Stress levels evaluation, measured by Daily Life, DASS-21, PCOS, PSS 14, salivary cortisol levels and Placebo effect (See 'Credibility/Expectancy questionnaire' 36. Devilly GJ, Borkovec TD. (2000). Psychometric properties of the credibility/expectancy questionnaire. J Behav Ther Exp Psychiatry. 31(2):73-86.) at baseline and at the end of the 8-weeks period.
Timepoint [1] 289486 0
8 weeks after initial evaluation
Secondary outcome [1] 302600 0
Descriptive epidemiology of the life routine of the PCOS patients, the factors, that affect the patients' life quality
and their possible association of the MBSR program to the placebo effect, using the questionnaires, mentioned above at the end of the 8 week period.
Timepoint [1] 302600 0
8 weeks after initial evaluation

Eligibility
Key inclusion criteria
Patients with PCOS diagnosis, according to the Rotterdam Criteria.
Minimum age
11 Years
Maximum age
40 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Pregnancy
2. Any genetic disorder or endocrine disease, which results in clinical or biochemical hyperandrogenemia.
3. Any kind of psychiatric disorder
4. Use of antipsychotic, antidepressant or anticolvusant medications
5. Current practice of any stress management technique or previous practice even in two months before the enrollment.
6. Refusal to participate or comply with the 8 weeks MBSR program
7. Participation in other studies.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization using a randomization table, created by an online computer software. (www.random.org)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
N/A
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/09/2012
Actual
11/09/2012
Date of last participant enrolment
Anticipated
30/03/2013
Actual
30/03/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment outside Australia
Country [1] 5058 0
Greece
State/province [1] 5058 0
Athens

Funding & Sponsors
Funding source category [1] 287203 0
University
Name [1] 287203 0
National & Kapodistrian University Medical School, Athens.
Country [1] 287203 0
Greece
Primary sponsor type
Individual
Name
Charikleia Stefanaki, M.D., M.Sc. Candidate
Address
34 Vyzantiou Str. Athens Postcode:12242
Country
Greece
Secondary sponsor category [1] 285966 0
None
Name [1] 285966 0
Address [1] 285966 0
Country [1] 285966 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289195 0
Evgenideion Hospital, Athens, Greece
Ethics committee address [1] 289195 0
20 Papadiamantopoulou Str. Athens, Greece Postcode : 11528
Ethics committee country [1] 289195 0
Greece
Date submitted for ethics approval [1] 289195 0
28/08/2012
Approval date [1] 289195 0
30/08/2012
Ethics approval number [1] 289195 0
n/a

Summary
Brief summary
The primary purpose of this study is to measure the MBSR program efficacy in decreasing stress levels in the PCOS patients. If the MBSR program proves to be efficient in decreasing stress levels, then it should integrated in the current management, along with the treatment.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34724 0
Dr Charikleia Stefanaki
Address 34724 0
Dr. Charikleia Stefanaki, 34, Vyzantiou Str. Athens, Greece, Postcode: 12242
Country 34724 0
Greece
Phone 34724 0
+306937036030
Fax 34724 0
Email 34724 0
[email protected]
Contact person for public queries
Name 17971 0
Dr Charikleia Stefanaki
Address 17971 0
Dr. Charikleia Stefanaki, 18 Alkmanos Str., Athens, Greece, Postcode: 11528
Country 17971 0
Greece
Phone 17971 0
+306937036030
Fax 17971 0
Email 17971 0
[email protected]
Contact person for scientific queries
Name 8899 0
Dr Charikleia Stefanaki
Address 8899 0
Dr. Charikleia Stefanaki, 34, Vyzantiou Str. Athens, Greece, Postcode: 12242
Country 8899 0
Greece
Phone 8899 0
+306937036030
Fax 8899 0
Email 8899 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseImpact of a mindfulness stress management program on stress, anxiety, depression and quality of life in women with polycystic ovary syndrome: A randomized controlled trial.2015https://dx.doi.org/10.3109/10253890.2014.974030
N.B. These documents automatically identified may not have been verified by the study sponsor.