Interdisciplinary Group Care for the Treatment of Endometriosis-associated Pain
NCT ID: NCT06549985
Last Updated: 2025-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2025-03-17
2028-09-30
Brief Summary
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Is PEEPS more effective than Education in decreasing pain interference?
Researchers will compare people receiving PEEPS plus usual care to those receiving Education plus usual care to see if people participating in PEEPS demonstrate improvements in pain, physical function, and quality of life.
Participants will:
* Complete baseline quality of life surveys
* Participate in an 8-session group care program
* Provide feedback on each session and the program globally
* Complete follow up quality of life surveys at PEEPS completion, 6- and 12-months post-completion.
* A sub-set will complete semi-structured interviews or focus groups about the experience of participating in PEEPS
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Peer Empowered Endometriosis Pain Support (PEEPS)
Participants in this arm will receive PEEPS plus usual care. PEEPS is comprised of eight weekly two-hour sessions delivered to groups of 6-10 participants. The sessions provide education on endometriosis, mindfulness, yoga, nutrition, and strategies to cope with chronic pain. Participants additionally receive peer and clinician support.
PEEPS
Participants will participate in the PEEPS program in addition to usual care.
Education
Participants in this arm will receive an educational handout providing the basics of endometriosis pathophysiology, diagnosis, and treatment plus usual care
Education
Participants will receive an educational handout on endometriosis in addition to usual care.
Interventions
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PEEPS
Participants will participate in the PEEPS program in addition to usual care.
Education
Participants will receive an educational handout on endometriosis in addition to usual care.
Eligibility Criteria
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Inclusion Criteria
* Operative confirmation of endometriosis
* Chronic pelvic pain (pain perceived to originate from the pelvis, not exclusively during menses, lasting ≥6 months)
* No plan to have surgery before or during the PEEPS cohort
* Able to attend at least six of the eight 2-hour weekly sessions on the Washington University campus
* Comfort reading and speaking English as groups and materials are in English
Exclusion Criteria
* Severe physical impairment (limiting yoga participation)
* History of hip or spine surgery given increased risk of harm and need for extensive activity modification
* Current or history of psychiatric disorder with psychosis in order to minimize risk of adverse mental health effects to participants
* Opioid use ≥ 5 days in the past 3 months, other than for the 6-week post-operative period
* History of surgical removal of bilateral ovaries
18 Years
48 Years
FEMALE
No
Sponsors
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Washington University School of Medicine
OTHER
Responsible Party
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Principal Investigators
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Whitney Ross, MD
Role: PRINCIPAL_INVESTIGATOR
Washington University School of Medicine
Locations
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WashU Medicine
St Louis, Missouri, United States
Countries
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Central Contacts
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Facility Contacts
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MIGS Research Team
Role: primary
Whitney Trotter Ross, MD
Role: backup
References
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Ross WT, Buday S, Yakel E, Khabele D, Balls-Berry J, As-Sanie S, Colditz G, Baumann AA. Does interdisciplinary group care for the treatment of endometriosis improve pain interference: protocol for a pilot randomised controlled trial at an urban academic medical centre. BMJ Open. 2025 Mar 5;15(3):e097372. doi: 10.1136/bmjopen-2024-097372.
Other Identifiers
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202402082
Identifier Type: -
Identifier Source: org_study_id