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

Endometriosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06211231
• Other study ID #: MY-ENDO-digital
• Status: Recruiting
• Phase: N/A
• Start date: February 7, 2024
• Est. completion date: December 31, 2026

Study information

• Verified date: April 2024
• Source: University of Aarhus
• Contact: Henrik Marschall, MSc
• Phone: +4522394563
• Email: hmars[@]psy.au.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 255
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Endometriosis

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital, Department of Gynaecology and Obstetrics	Aarhus	Central Jutland Region
Denmark	The Danish Endometriosis Patients Association	Billund

Sponsors (2)

Lead Sponsor	Collaborator
University of Aarhus	Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of Life (QoL)	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.	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.)
Secondary	Quality of Life subdomains	Quality of Life subdomains will be measured using the six add-on modules to Endometriosis Health Profile-30, on a scale from 0 to 100, with higher scores indicating worse quality of life.	Change in Quality of Life subdomains from pre-randomization to after sessions 5 and 10, and 3, 6 and 12 months post-randomization.
Secondary	Work ability	Work ability is measured using the Work Ability Index scale, on a scale from 7 to 49, with higher scores indicating better work ability.	Change in Work Ability Index from pre-randomization to after sessions 5 and 10, and 3, 6 and 12 months post-randomization.
Secondary	Pain and other endometriosis symptoms	Pain and other endometriosis symptoms is measured on numeric rating scales (NRS) ranging from 0 (no pain/no symptom) to 10 (worst pain imaginable/worst symptom imaginable.) Symptoms includes (among others) noncyclical pelvic pain, dysmenorrhea, dysuria, dyspareunia, dyschezia, fatigue, constipation, diarrhea.	Change in pain and other endometriosis symptoms from pre-randomization to after sessions 5 and 10, and 3, 6 and 12 months post-randomization.
Secondary	Pain acceptance	Pain acceptance is measured using the Chronic Pain Acceptance Questionnaire, on a scale from 0 to 120, with higher scores indicating more pain acceptance.	Change in Chronic Pain Acceptance Questionnaire from pre-randomization to after sessions 5 and 10, and 3, 6 and 12 months post-randomization.
Secondary	Sleep quality	Sleep quality is measured using the Pittsburgh Sleep Quality Index, on a scale from 0 to 21, with higher scores indicating worse sleep quality.	Change in Pittsburgh Sleep Quality Index from pre-randomization to after sessions 5 and 10, and 3, 6 and 12 months post-randomization.
Secondary	Fatigue	Fatigue is measured using the Chalder Fatigue Scale, on a scale from 0 to 33, with higher scores indicating more fatigue.	Change in fatigue from pre-randomization to after sessions 5 and 10, and 3, 6 and 12 months post-randomization.
Secondary	Wellbeing	Wellbeing is measured using the World Health Organization - Five Wellbeing Index, on a scale from 0 to 25, with higher scores indicating better wellbeing.	Change in World Health Organization - Five Wellbeing Index from pre-randomization to after sessions 5 and 10, and 3, 6 and 12 months post-randomization.
Secondary	Pain catastrophizing	Pain catastrophizing is measured using the Pain Catastrophizing Scale, on a scale from 0 to 52, with higher scores indicating more severe pain catastrophizing.	Change in Pain Catastrophizing Scale from pre-randomization to after sessions 5 and 10, and 3, 6 and 12 months post-randomization.
Secondary	Anxiety symptoms	Anxiety symptoms will be measured using the Generalized Anxiety Disorder Screener, on a scale from 0 to 21, with higher scores indicating more severe anxiety symptoms.	Change in Generalized Anxiety Disorder Screener from pre-randomization to after sessions 5 and 10, and 3, 6 and 12 months post-randomization.
Secondary	Depressive symptoms	Depressive symptoms will be measured by Beck´s Depression Inventory, on a scale from 0 to 63, with higher scores indicating more severe depressive symptoms.	Change in Beck's Depression Inventory from pre-randomization to after sessions 5 and 10, and 3, 6 and 12 months post-randomization.
Secondary	Perceived stress	Perceived stress will be measured by The Perceived Stress Scale, on a scale from 0 to 40, with higher scores indicating higher perceived stress.	Change in Perceived Stress Scale from pre-randomization to after sessions 5 and 10, and 3, 6 and 12 months post-randomization.
Secondary	Psychological flexibility	Psychological flexibility will be measured by the Acceptance and Action Questionnaire-II (AAQ-II), on a scale from 7 to 49, with higher scores indicating less psychological flexibility.	Change in Acceptance and Action Questionnaire-II from pre-randomization to after sessions 5 and 10, and 3, 6 and 12 months post-randomization.
Secondary	Mindfulness	Mindfulness will be measured by the Five Facet Mindfulness Questionnaire, on a scale from 39 to 195, with higher scores indicating more mindfulness.	Change in Five Facet Mindfulness Questionnaire from pre-randomization to after sessions 5 and 10, and 3, 6 and 12 months post-randomization.