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

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

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

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
    Denmark

    Active - Recruiting

  • The Danish Endometriosis Patients Association

    Billund, DK-7190
    Denmark

    Active - Recruiting

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