Last updated: April 2, 2024
Sponsor: University of Aarhus
Overall Status: Active - Recruiting
Phase
N/A
Condition
Endometriosis
Treatment
Digitally delivered mindfulness- and acceptance-based psychological intervention
Digitally delivered mindfuness- and acceptance-based psychological intervention
Clinical Study ID
NCT06211231
MY-ENDO-digital
Ages > 18 Female
Study Summary
Eligibility Criteria
Inclusion
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-pointnumeric rating scale (NRS) from 0 = no pain/fatigue to 10 = worst imaginablepain/fatigue symptom) or reduced endometriosis-related quality of life (measured bythe 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 HumanReproduction 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 weekduring the treatment period.
Exclusion
Exclusion Criteria:
- Under 18 years old.
- Severe psychiatric diagnosis made by a psychiatrist and/or ongoing psychiatrictreatment.
- Pregnancy or planned pregnancy during the study period.
- An estimated lack of capacity or surplus energy to enter into a digital mindfulnesstreatment, for instance, because of:
- major life events taking place at the same time (e.g., divorce, loss of a closerelative, etc.)
- linguistic or cultural barriers
Study Design
Total Participants: 255
Treatment Group(s): 2
Primary Treatment: Digitally delivered mindfulness- and acceptance-based psychological intervention
Phase:
Study Start date:
February 07, 2024
Estimated Completion Date:
December 31, 2026
Connect with a study center
Aarhus University Hospital, Department of Gynaecology and Obstetrics
Aarhus, Central Jutland Region DK-8000
DenmarkActive - Recruiting
The Danish Endometriosis Patients Association
Billund, DK-7190
DenmarkActive - Recruiting
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