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

University of Aarhus

Status: Enrolling

Conditions: Endometriosis

Treatments: Behavioral: Digitally delivered mindfulness- and acceptance-based psychological intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT06211231

MY-ENDO-digital

Details and patient eligibility

About

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.

Enrollment: 255 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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255 participants in 3 patient groups

Self-guided digital intervention

Experimental group

Description:

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:

Behavioral: Digitally delivered mindfulness- and acceptance-based psychological intervention

Therapist-guided digital intervention

Experimental group

Description:

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:

Behavioral: Digitally delivered mindfulness- and acceptance-based psychological intervention

No-treatment control group (waiting list)

No Intervention group

Description:

Participants randomized to the waiting list will be offered one of the two experimental treatments. Participants continue medical treatment as usual.