Clinical trial NCT06211231: MY-ENDO -- Mind Your ENDOmetriosis: a Digital Mindfulness- and Acceptance-based Endometriosis Self-management Program
Official title: MY-ENDO -- Mind Your ENDOmetriosis: a Digital Mindfulness- and Acceptance-based Endometriosis Self-management Program
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Endometriosis
Keywords: Endometriosis
Quality of life
Digital psychological interventions
Randomized controlled trial
Mindfulness-based intervention
Acceptance and commitment therapy
Pelvic pain
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
First posted: 2024-01-18
Enrollment: 255
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are randomized to one of three groups: 1) self-guided digital intervention, 2) therapist-guided digital intervention, or 3) no-treatment control group (waiting list)
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Quality of Life (QoL)
timeFrame: 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 outcomes:
measure: Quality of Life subdomains
timeFrame: Change in Quality of Life subdomains from pre-randomization to after sessions 5 and 10, and 3, 6 and 12 months post-randomization.
measure: Work ability
timeFrame: Change in Work Ability Index from pre-randomization to after sessions 5 and 10, and 3, 6 and 12 months post-randomization.
measure: Pain and other endometriosis symptoms
timeFrame: Change in pain and other endometriosis symptoms from pre-randomization to after sessions 5 and 10, and 3, 6 and 12 months post-randomization.
measure: Pain acceptance
timeFrame: Change in Chronic Pain Acceptance Questionnaire from pre-randomization to after sessions 5 and 10, and 3, 6 and 12 months post-randomization.
measure: Sleep quality
timeFrame: Change in Pittsburgh Sleep Quality Index from pre-randomization to after sessions 5 and 10, and 3, 6 and 12 months post-randomization.
measure: Fatigue
timeFrame: Change in fatigue from pre-randomization to after sessions 5 and 10, and 3, 6 and 12 months post-randomization.
measure: Wellbeing
timeFrame: 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.
measure: Pain catastrophizing
timeFrame: Change in Pain Catastrophizing Scale from pre-randomization to after sessions 5 and 10, and 3, 6 and 12 months post-randomization.
measure: Anxiety symptoms
timeFrame: Change in Generalized Anxiety Disorder Screener from pre-randomization to after sessions 5 and 10, and 3, 6 and 12 months post-randomization.
measure: Depressive symptoms
timeFrame: Change in Beck's Depression Inventory from pre-randomization to after sessions 5 and 10, and 3, 6 and 12 months post-randomization.
measure: Perceived stress
timeFrame: Change in Perceived Stress Scale from pre-randomization to after sessions 5 and 10, and 3, 6 and 12 months post-randomization.
measure: Psychological flexibility
timeFrame: Change in Acceptance and Action Questionnaire-II from pre-randomization to after sessions 5 and 10, and 3, 6 and 12 months post-randomization.
measure: Mindfulness
timeFrame: Change in Five Facet Mindfulness Questionnaire from pre-randomization to after sessions 5 and 10, and 3, 6 and 12 months post-randomization.
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital, Department of Gynaecology and Obstetrics
state: Central Jutland Region
city: Billund
country: Denmark
facility: The Danish Endometriosis Patients Association
Study officials:
affiliation: University of Aarhus
name: Henrik Marschall, MSc
role: PRINCIPAL_INVESTIGATOR
References: