Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
250 participants
INTERVENTIONAL
2024-10-04
2027-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Standard care (control group)
No interventions assigned to this group
Standard care and an anti-inflammatory diet (DI group)
Anti-inflammatory diet (DI)
12-week personalized dietary advice based on the Dutch Dietary Guidelines under the guidance of a dietician.
Standard care, anti-inflammatory diet and cognitive behavioral therapy (DI + CBT group)
Anti-inflammatory diet (DI)
12-week personalized dietary advice based on the Dutch Dietary Guidelines under the guidance of a dietician.
Cognitive behavioral therapy (CBT)
Seven individual sessions led by a psychotherapist. The content of the CBT will be psycho-education regarding pain mechanisms and DI.
Standard care and cognitive behavioral therapy (CBT group)
Cognitive behavioral therapy (CBT)
Seven individual sessions led by a psychotherapist. The content of the CBT will be psycho-education regarding pain mechanisms and DI.
Healthy controls
Healthy controls without endometriosis
No interventions assigned to this group
Interventions
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Anti-inflammatory diet (DI)
12-week personalized dietary advice based on the Dutch Dietary Guidelines under the guidance of a dietician.
Cognitive behavioral therapy (CBT)
Seven individual sessions led by a psychotherapist. The content of the CBT will be psycho-education regarding pain mechanisms and DI.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* NRS pain score \> 4\*
* Age from 17 years
* Premenopausal status
* Body Mass Index (BMI) 18-30 kg/m2
* Ability to understand the explanation about the diet intervention (DI) and CBT\*
* Willing to follow the DI\*
* Willing to continue their use of food supplements
* Willing to undergo CBT\*
* Willing to collect menstrual effluent, and therefore willing to have two stop weeks from hormonal contraception (if applicable) during the study period.
Exclusion Criteria
* Eating disorder
* Diagnosed with Crohn's disease, Ulcerative Colitis, short bowel syndrome or another chronic inflammatory disease
* Self-reported celiac disease
* Vegan diet
* Smoking
* Use of immunosuppressive or psychotropic medication
* Score on FFQ \> 120
* Diagnosed with severe mental disorder currently requiring treatment by psychiatrist
* NRS average score below 4 during the last month
* Participation in another intervention study
* Unable to speak Dutch or to understand the intervention
* Need for surgery during the participation in the study
* Serious pain (NRS \> 4) from other origin than endometriosis
* Pregnant
* Scalp hair shorter than 4 cm
* Only applicable to patients with endometriosis
17 Years
FEMALE
Yes
Sponsors
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ZonMw: The Netherlands Organisation for Health Research and Development
OTHER
Belgian Volition SRL
UNKNOWN
ASSOCIATION OF PEOPLE WITH ENDOMETRIOSIS I AM 1 IN 10
UNKNOWN
Wageningen University and Research
OTHER
Endometriosis UK
UNKNOWN
University College Cork
OTHER
SVEUCILISTE U ZAGREBU MEDICINSKI FAKULTET
UNKNOWN
UNIWERSYTET MEDYCZNY W LUBLINIE
UNKNOWN
University of Edinburgh
OTHER
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
OTHER
Université Catholique de Louvain
OTHER
University Bonn
UNKNOWN
Biopsychology
UNKNOWN
Horizon Europe
UNKNOWN
Radboud University Medical Center
OTHER
Responsible Party
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Locations
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Jeroen Bosch Hospital (JBZ)
's-Hertogenbosch, , Netherlands
Rijnstate Hospital
Arnhem, , Netherlands
Amphia
Breda, , Netherlands
Catharina Hospital
Eindhoven, , Netherlands
Radboud University Medical Center
Nijmegen, , Netherlands
Countries
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Central Contacts
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Facility Contacts
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M.C. Herman, PhD
Role: primary
P Dijkhuizen, PhD
Role: primary
J.S. Hoogstad-van Evert, PhD
Role: primary
H.A.A.M van Vliet, PhD, MD
Role: primary
E Huijs, B
Role: primary
Other Identifiers
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NL86247.091.24
Identifier Type: -
Identifier Source: org_study_id
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