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

NCT ID: NCT06211231

Last Updated: 2024-04-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 255 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-07
• Study Completion Date: 2026-12-31

Brief 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.

Conditions

Endometriosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Digitally delivered mindfulness- and acceptance-based psychological intervention

Intervention Type: BEHAVIORAL

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.

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.

Group Type: EXPERIMENTAL

Digitally delivered mindfulness- and acceptance-based psychological intervention

Intervention Type: BEHAVIORAL

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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Aarhus University Hospital

OTHER

Sponsor Role: collaborator

University of Aarhus

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Henrik Marschall, MSc

Role: PRINCIPAL_INVESTIGATOR

University of Aarhus

Locations

Aarhus University Hospital, Department of Gynaecology and Obstetrics

Aarhus, Central Jutland, Denmark

Site Status: RECRUITING

The Danish Endometriosis Patients Association

Billund, , Denmark

Site Status: RECRUITING

Countries

Denmark

Central Contacts

Henrik Marschall, MSc

Role: CONTACT

hmars@psy.au.dk

+4522394563

Facility Contacts

Anne Egekvist, Phd, MD

Role: primary

Karina E Hansen, PhD, MSc

Role: primary

Other Identifiers

MY-ENDO-digital

Identifier Type: -

Identifier Source: org_study_id