Clinical trial NCT06332560: Pain in Endometriosis And the Relation to Lifestyle
Official title: Pain in Endometriosis And the Relation to Lifestyle: Effectiveness of a Dietary Intervention and Cognitive Behavioral Therapy in Endometriosis-associated Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Endometriosis
Adenomyosis
Keywords: endometriosis
pain
quality of life
immunology
anti-inflammatory diet
cognitive behavioral therapy
adenomyosis
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: ZonMw: The Netherlands Organisation for Health Research and Development
First posted: 2024-03-27
Enrollment: 200
Sex: FEMALE
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to investigate the effect of an anti-inflammatory diet and cognitive behavioral therapy (CBT) on pain symptoms, health related quality of life and the effect on inflammatory characteristics in serum and menstruum samples as well as the effect on the gut and vaginal microbiome in women with endometriosis.

Participants will be randomized between standard care (control group), standard care and an anti-inflammatory diet, or standard care, anti-inflammatory diet and cognitive behavioral therapy or CBT alone.

Participants will follow an anti-inflammatory diet based on the Dutch Dietary Guidelines or CBT or a combination of both interventions for 12 weeks. They will receive personalized dietary advice from a dietician and recipes will be available. cognitive behavioral therapy will be administered in a total of seven individual sessions led by a psychotherapist. The content of these sessions will be psycho-education regarding pain mechanisms and diet.


Eligibility criteria: Inclusion Criteria:

* 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:

* Recurrent miscarriages (\> 2)
* 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

Primary outcomes:
measure: Change in Pain intensity assessed by the Numerical Rating Scale
timeFrame: 3 months
measure: Change in inflammatory characteristics in menstruum
timeFrame: 3 months
Secondary outcomes:
measure: Change in Health Related Quality of Life assessed by the Endometriosis Health Profile 30
timeFrame: 3 months
measure: Change in general Quality of Life assessed by the Short Form 36
timeFrame: 3 months
measure: Change in the composition of vaginal and intestinal microbiome
timeFrame: 3 months
measure: Change in Objective stress assessed by measuring scalp hair cortisol levels
timeFrame: 3 months
measure: Adherence and anti-inflammatory status of the diet
timeFrame: 3 months
Other outcomes:
measure: Change in sleep quality assessed by the PSQI
timeFrame: 3 months
measure: Change in physical activity level assessed by the IPAQ-SF
timeFrame: 3 months
measure: Change in Subjective stress assessed by the Perceived Stress Scale
timeFrame: 3 months
measure: Changes in pain cognitions assessed by the Pain anxiety symptom scale
timeFrame: 3 months
measure: Changes in pain cognitions assessed by the pain catastrophizing Scale
timeFrame: 3 months
measure: Changes in Fatigue assessed by the checklist individual strength
timeFrame: 3 months
measure: Anti-inflammatory diet rating
timeFrame: At the end of the intervention (3 months), when completed the diet intervention
Locations:
city: 's-Hertogenbosch
country: Netherlands
facility: Jeroen Bosch Hospital (JBZ)
city: Arnhem
country: Netherlands
facility: Rijnstate Hospital
city: Breda
country: Netherlands
facility: Amphia
city: Eindhoven
country: Netherlands
facility: Catharina Hospital
city: Nijmegen
country: Netherlands
facility: Radboud University Medical Center
Study officials:
References: