Interdisciplinary Group Care for the Treatment of Endometriosis-associated Pain

NCT06549985 | Recruiting

• 1 other identifier: 202402082
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to determine if Peer Empowered Endometriosis Pain Support (PEEPS), an 8-week interdisciplinary, integrative group care program, decreases pain interference in participants with endometriosis-associated chronic pelvic pain between the ages 18 and 48. The main question we aim to answer is: 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

Conditions

Endometriosis; Pelvic Pain

Keywords

Group care; Integrative care; Pelvic floor physical therapy; Mindfulness; Patient-centered outcomes

Outcome Measures

Primary Outcomes (1)

• Patient Reported Outcomes Measurement Information System (PROMIS) pain interference Short Form (SF) 8a

  Validated, 8-question survey that assesses pain interference in daily activities

  Baseline, immediately after the intervention

Other Outcomes (7)

• PROMIS pain interference SF 8a

  Baseline, 6- and 12-months after the intervention

• PROMIS pain intensity

  Baseline, immediately after the intervention, 6- and 12-months after the intervention

• Endometriosis Health Profile-30

  Baseline, immediately after the intervention, 6- and 12-months after the intervention

Study Arms (2)

Peer Empowered Endometriosis Pain Support (PEEPS)

EXPERIMENTAL

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.

Behavioral: PEEPS

Education

ACTIVE COMPARATOR

Participants in this arm will receive an educational handout providing the basics of endometriosis pathophysiology, diagnosis, and treatment plus usual care

Behavioral: Education

Interventions

PEEPS BEHAVIORAL

Participants will participate in the PEEPS program in addition to usual care.

Peer Empowered Endometriosis Pain Support (PEEPS)

Education BEHAVIORAL

Participants will receive an educational handout on endometriosis in addition to usual care.

Education

Eligibility Criteria

• Age: 18 Years - 48 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18-48 years
• 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

You may not qualify if:

• Currently pregnant
• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

WashU Medicine

St Louis, Missouri, 63108, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 40044193 DERIVED

MeSH Terms

Conditions

Endometriosis; Pelvic Pain

Interventions

Educational Status

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

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Officials

• Whitney Ross, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Whitney Ross, MD

CONTACT

314-747-5470; ross.w@email.wustl.edu

Jaime Strickland, MA

CONTACT

314-747-1390; jaime.strickland@wustl.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2024
• First Posted: August 12, 2024
• Study Start: March 17, 2025
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2028
• Last Updated: December 26, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: All scientific data generated from this project will be made available no later than the time of an associated publication or 12 months after completion of the final data point, whichever is sooner.
• Access Criteria: The human subjects' data shared will be within the Institutional Review Board (IRB) bounds. The human subject data will be de-identified and made available via controlled access to the approved user(s) who signed the Data Use Agreement (DUA) to ensure the requester(s) have a legitimate reason for access, and agree not to attempt re-identification of participants and not to distribute data to unauthorized users.

Locations

US (1)