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

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.

Study Overview

• Status: Recruiting
• Conditions: Endometriosis
• Intervention / Treatment: Behavioral: Digitally delivered mindfulness- and acceptance-based psychological intervention

• Study Type: Interventional
• Enrollment (Estimated): 255
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Henrik Marschall, MSc; Phone Number: +4522394563; Email: hmars@psy.au.dk

Study Locations

• Denmark
  • Billund, Denmark, DK-7190
    • Recruiting
    • The Danish Endometriosis Patients Association
    • Contact: Karina E Hansen, PhD, MSc
  • Central Jutland Region
    • Aarhus, Central Jutland Region, Denmark, DK-8000
      • Recruiting
      • Aarhus University Hospital, Department of Gynaecology and Obstetrics
      • Contact: Anne Egekvist, Phd, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.
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.	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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Collaborators and Investigators

• Sponsor: University of Aarhus
• Collaborators: Aarhus University Hospital
• Investigators: Principal Investigator: Henrik Marschall, MSc, University of Aarhus

Study record dates

Study Major Dates

• Study Start (Actual): February 7, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: January 8, 2024
• First Submitted That Met QC Criteria: January 8, 2024
• First Posted (Actual): January 18, 2024

Study Record Updates

• Last Update Posted (Actual): April 3, 2024
• Last Update Submitted That Met QC Criteria: April 2, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Quality of life; Randomized controlled trial; Pelvic pain; Endometriosis; Mindfulness-based intervention; Acceptance and commitment therapy; Digital psychological interventions
• Additional Relevant MeSH Terms: Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Endometriosis
• Other Study ID Numbers: MY-ENDO-digital

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: When participant inclusion has ended, data can be shared in accordance with the International Committee of Medical Journal Editors (ICJME) guidelines, if relevant research objectives are provided. Data sharing will require approval from the Research Ethics Committee in Denmark and the Danish Data Protection Agency, and the requesting party shall cover any fees associated with data sharing. Requests for data can be addressed to hmars@psy.au.dk.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No