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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• ≥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.

Locations
Other Locations
Denmark
Aarhus University Hospital, Department of Gynaecology and Obstetrics
RECRUITING
Aarhus
The Danish Endometriosis Patients Association
RECRUITING
Billund
Contact Information
Primary
Henrik Marschall, MSc
hmars@psy.au.dk
+4522394563
Time Frame
Start Date: 2024-02-07
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 255
Treatments
Experimental: Self-guided digital intervention
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.
Experimental: Therapist-guided digital intervention
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.
No_intervention: No-treatment control group (waiting list)
Participants randomized to the waiting list will be offered one of the two experimental treatments. Participants continue medical treatment as usual.
Related Therapeutic Areas
Sponsors
Leads: University of Aarhus
Collaborators: Aarhus University Hospital

This content was sourced from clinicaltrials.gov