MY-ENDO -- Mind Your ENDOmetriosis: a Digital Mindfulness- and Acceptance-based Endometriosis Self-management Program
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 255
- 试验地点
- 2
- 主要终点
- Quality of Life (QoL)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
盲法说明
Only principal investigator is blinded, as neither participants nor care providers can be feasibly blinded, since both parties will know if a video consultation is provided or not. The study includes only patient-reported outcomes, hence, the outcome assessors are the participants.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •≥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.
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Digitally delivered mindfulness- and acceptance-based psychological intervention (Behavioral)
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.
干预措施: Digitally delivered mindfulness- and acceptance-based psychological intervention (Behavioral)
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.
结局指标
主要结局
Quality of Life (QoL)
时间窗: 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.)
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.
次要结局
- 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 catastrophizing(Change in Pain Catastrophizing Scale from pre-randomization to after sessions 5 and 10, and 3, 6 and 12 months post-randomization.)
- Mindfulness(Change in Five Facet Mindfulness Questionnaire from pre-randomization to after sessions 5 and 10, and 3, 6 and 12 months post-randomization.)
- 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.)
- 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(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(Change in Perceived Stress Scale from pre-randomization to after sessions 5 and 10, and 3, 6 and 12 months post-randomization.)
- 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.)
- Quality of Life subdomains(Change in Quality of Life subdomains from pre-randomization to after sessions 5 and 10, and 3, 6 and 12 months post-randomization.)
- Pain and other endometriosis symptoms(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(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(Change in Pittsburgh Sleep Quality Index from pre-randomization to after sessions 5 and 10, and 3, 6 and 12 months post-randomization.)
- Fatigue(Change in fatigue from pre-randomization to after sessions 5 and 10, and 3, 6 and 12 months post-randomization.)