Tests a digital mindfulness program for people with endometriosis
Tests an online mindfulness and acceptance program for adults with endometriosis pain.
Key facts
- Who runs it
- University of Aarhus
- Where
- Aarhus and Billund, DenmarkSee the 2 sites
- Trial code
- Registry title
- MY-ENDO -- Mind Your ENDOmetriosis: a Digital Mindfulness- and Acceptance-based Endometriosis Self-management Program
- Status
- Recruiting
- People taking part
- 255 people, planned
- Started
- 7 Feb 2024
- Expected to end
- 31 Dec 2026
- Type of study
- Interventional, 3 groupsOne group gets no study treatment, for comparison.
- Treatments tested
- Digitally delivered mindfulness- and acceptance-based psychological intervention
- Record updated
- 3 April 2024
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with endometriosis who have moderate to severe pelvic pain or fatigue, or a lower quality of life because of it, and who have already tried treatment.
- Age
- 18 years or older
- Sex
- Women only
- Disease stage
- Endometriosis diagnosed by a gynecologist (self-reported). Moderate to severe pelvic pain (NRS > 2) or fatigue (NRS > 2), or low endometriosis-related quality of life (one or more EHP-30 subscale mean scores ≥ 40.00).
- Earlier treatment
- Relevant clinical and/or surgical treatment according to the ESHRE guidelines for endometriosis has been attempted.
Main reasons for not taking part
- Severe psychiatric diagnosis made by a psychiatrist and/or ongoing psychiatric treatment
- Pregnancy or planned pregnancy during the study period
- Major life events at the same time, such as divorce or loss of a close relative
- Linguistic or cultural barriers
- Not willing to practice mindfulness and yoga at home for 30-45 minutes 5-7 days a week
The registry criteria, word for word
Show all 15 criteriaShow less
Who can take part
- ≥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
Who cannot take part
- Severe psychiatric diagnosis made by a psychiatrist and/or ongoing psychiatric treatment
- Under 18 years old
- 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
Where in Denmark
- Aarhus University Hospital, Department of Gynaecology and ObstetricsAarhus, DenmarkContact: Anne Egekvist, Phd, MDTaking people
- The Danish Endometriosis Patients AssociationBillund, DenmarkContact: Karina E Hansen, PhD, MScTaking people
About the trial
What the trial wants to find out
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.
The 3 groups in the trial
- Self-guided digital interventionTreatment being tested
The program consists of 10 online sessions that teach and guide different endometriosis-related themes. The sessions include mindfulness-meditation, yoga, written assignments and patient-education, that are accessed through the digital platform. Participants continue medical treatment as usual.
Treatment: Digitally delivered mindfulness- and acceptance-based psychological intervention
- Therapist-guided digital interventionTreatment being tested
The program consists of 10 online sessions that teach and guide different endometriosis-related themes. The sessions include mindfulness-meditation, yoga, written assignments and patient-education, that are accessed through the digital platform. This arm includes 11 online video-consultations with a therapist (one prior to starting and one for each session.) Participants continue medical treatment as usual.
Treatment: Digitally delivered mindfulness- and acceptance-based psychological intervention
- No-treatment control group (waiting list)No study treatment, for comparison
Participants randomized to the waiting list will be offered one of the two experimental treatments. Participants continue medical treatment as usual.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- MY-ENDO -- Mind Your ENDOmetriosis: a Digital Mindfulness- and Acceptance-based Endometriosis Self-management Program
- Plain-language title
- Tests a digital mindfulness program for people with endometriosisGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 3 April 2024