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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
255
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.
Aarhus University Hospital, Department of Gynaecology and Obstetrics
Aarhus, Central Jutland, Denmark
RECRUITINGThe Danish Endometriosis Patients Association
Billund, Denmark
RECRUITINGQuality 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.
Time frame: 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.)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Change in Five Facet Mindfulness Questionnaire from pre-randomization to after sessions 5 and 10, and 3, 6 and 12 months post-randomization.