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

Обзор

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.

Вмешательства

• Поведенческое 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.

Первичные конечные точки

• Quality of Life (QoL) [Срок оценки: 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.)]

Вторичные конечные точки (12)

• Quality of Life subdomains [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Change in Pittsburgh Sleep Quality Index from pre-randomization to after sessions 5 and 10, and 3, 6 and 12 months post-randomization.]
• Fatigue [Срок оценки: Change in fatigue from pre-randomization to after sessions 5 and 10, and 3, 6 and 12 months post-randomization.]
• Wellbeing [Срок оценки: 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 [Срок оценки: Change in Pain Catastrophizing Scale from pre-randomization to after sessions 5 and 10, and 3, 6 and 12 months post-randomization.]
• Anxiety symptoms [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Change in Perceived Stress Scale from pre-randomization to after sessions 5 and 10, and 3, 6 and 12 months post-randomization.]
• Psychological flexibility [Срок оценки: Change in Acceptance and Action Questionnaire-II from pre-randomization to after sessions 5 and 10, and 3, 6 and 12 months post-randomization.]

Критерии участия

Критерии включения

• ≥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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Дания · 2 центра

• Aarhus University Hospital, Department of Gynaecology and Obstetrics — Aarhus
• The Danish Endometriosis Patients Association — Billund

Идентификаторы

NCT: NCT06211231 · MY-ENDO-digital

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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