NCT06211231 MY-ENDO -- Mind Your ENDOmetriosis: a Digital Mindfulness- and Acceptance-based Endometriosis Self-management Program
| NCT ID | NCT06211231 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Aarhus |
| Condition | Endometriosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 255 participants |
| Start Date | 2024-02-07 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 255 participants in total. It began in 2024-02-07 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of the study is to assess the effect of a digital mindfulness- and acceptance-based psychological intervention on quality of life, work ability, pain experience and physical and mental health in participants experiencing chronic pain, fatigue and/or reduced quality of life due to endometriosis.
Eligibility Criteria
Inclusion Criteria: * ≥18 years old. * Signed informed consent. * Endometriosis diagnosed by a gynecologist based on the medical case history, ultrasound, laparoscopy, or MRI (all self-reported). * Moderate to severe symptoms (pelvic pain and/or fatigue measured on an 11-point numeric rating scale (NRS) from 0 = no pain/fatigue to 10 = worst imaginable pain/fatigue symptom) or reduced endometriosis-related quality of life (measured by the EHP-30): * Moderate to severe endometriosis-related chronic pelvic pain (NRS \> 2) or * Moderate to severe endometriosis-related fatigue (NRS \> 2) or * Low endometriosis-related quality of life (one or more EHP-30 subscale mean scores ≥ 40.00). * Relevant clinical and/or surgical treatment according to the European Society of Human Reproduction and Embryology (ESHRE) guidelines for endometriosis has been attempted. * Willingness to practice mindfulness and yoga at home for 30-45 minutes 5-7 days a week during the treatment period. Exclusion Criteria: * Under 18 years old. * Severe psychiatric diagnosis made by a psychiatrist and/or ongoing psychiatric treatment. * Pregnancy or planned pregnancy during the study period. * An estimated lack of capacity or surplus energy to enter into a digital mindfulness treatment, for instance, because of: * major life events taking place at the same time (e.g., divorce, loss of a close relative, etc.) * linguistic or cultural barriers
Contact & Investigator
Henrik Marschall, MSc
PRINCIPAL INVESTIGATOR
University of Aarhus
Frequently Asked Questions
Who can join the NCT06211231 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Endometriosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06211231 currently recruiting?
Yes, NCT06211231 is actively recruiting participants. Contact the research team at hmars@psy.au.dk for enrollment information.
Where is the NCT06211231 trial being conducted?
This trial is being conducted at Aarhus, Denmark, Billund, Denmark.
Who is sponsoring the NCT06211231 clinical trial?
NCT06211231 is sponsored by University of Aarhus. The principal investigator is Henrik Marschall, MSc at University of Aarhus. The trial plans to enroll 255 participants.