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Recruiting Not applicable

MY-ENDO -- Mind Your ENDOmetriosis: a Digital Mindfulness- and Acceptance-based Endometriosis Self-management Program

NCT06211231 · tracked via the Priya Life Science Denmark tracker
Phase
Not applicable
Started
2024-02-07
Last updated
2024-04-03

Condition(s) studied

Endometriosis

Investigational drug(s) / intervention(s)

Digitally delivered mindfulness- and acceptance-based psychological intervention

Digitally delivered mindfulness- and acceptance-based psychological intervention: MY-ENDO is developed specifically for endometriosis and includes ten themes; one for each session: 1) endometriosis, 2) chronic pain and pain mechanisms, 3) stress, 4) thoughts and feelings, 5) grief, 6) identity and meaning, 7) everyday life and relations, 8) health, diet and exercise, 9) value-based action and 10) a good life with endometriosis.

Study 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

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Quality of Life (QoL) — Change in Endometriosis Health Profile-30 from pre-randomization to after sessions 5 and 10, and 3, 6 and 12 months post-randomization. Primary outcome comparison is between baseline and post-intervention (after session 10.)
    QoL is measured using the Endometriosis Health Profile-30 scale, on a scale from 0 to 100, with higher scores indicating worse quality of life.

Trial sites (2)

FacilityCityRegionStatus
Aarhus University Hospital, Department of Gynaecology and Obstetrics Aarhus Central Jutland Recruiting
The Danish Endometriosis Patients Association Billund Denmark Recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06211231 on ClinicalTrials.gov ↗ ← All trials in Denmark