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

NCT06211231 | Recruiting

• 1 other identifier: MY-ENDO-digital
• Study Type: interventional
• Target: 255
• Locations: 1 country
• Sites: 2

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.

Conditions

Endometriosis

Keywords

Endometriosis; Quality of life; Digital psychological interventions; Randomized controlled trial; Mindfulness-based intervention; Acceptance and commitment therapy; Pelvic pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• 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.

• 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

  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.

Study Arms (3)

Self-guided digital intervention

EXPERIMENTAL

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

Therapist-guided digital intervention

EXPERIMENTAL

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

No-treatment control group (waiting list)

NO INTERVENTION

Participants randomized to the waiting list will be offered one of the two experimental treatments. Participants continue medical treatment as usual.

Interventions

Digitally delivered mindfulness- and acceptance-based psychological intervention BEHAVIORAL

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.

Self-guided digital intervention; Therapist-guided digital intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Aarhus: lead
• Aarhus University Hospital: collaborator

Study Sites (2)

Aarhus University Hospital, Department of Gynaecology and Obstetrics

Aarhus, Central Jutland, DK-8000, Denmark

RECRUITING

The Danish Endometriosis Patients Association

Billund, DK-7190, Denmark

RECRUITING

MeSH Terms

Conditions

Endometriosis; Pelvic Pain

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Henrik Marschall, MSc

  University of Aarhus

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Henrik Marschall, MSc

CONTACT

+4522394563; hmars@psy.au.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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)

Study Record Dates

• First Submitted: January 8, 2024
• First Posted: January 18, 2024
• Study Start: February 7, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 3, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share

Locations

DK (2)