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Studies

Interventional Recruiting

NCT06549985 on ClinicalTrials.gov

Interdisciplinary Group Care for the Treatment of Endometriosis-associated Pain

Official title: Interdisciplinary Group Care for the Treatment of Endometriosis-associated Pain: the Peer Empowered Endometriosis Pain Support (PEEPS) Pilot Randomized Controlled Trial

  • Sponsor: George Washington University
  • Enrollment: 60 (Estimated)
  • Study start: 2025-03-17 (Actual)
  • Primary completion: 2027-09-30 (Estimated)
  • Study completion: 2028-09-30 (Estimated)
  • Allocation: Randomized
  • InterventionModel: Parallel
  • Masking: None
  • PrimaryPurpose: Treatment

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

Intervention / Treatment

  • Behavioral: PEEPS
  • Behavioral: Education

Primary Outcome Measures

  • Patient Reported Outcomes Measurement Information System (PROMIS) pain interference Short Form (SF) 8a (Baseline, immediately after the intervention)
    Validated, 8-question survey that assesses pain interference in daily activities

Countries

United States

Locations and Investigators

  • WashU Medicine, St Louis, United States (Recruiting)
    • MIGS Research Team
    • Whitney Trotter Ross, MD
    • Whitney Ross, MD (Principal Investigator)

Study Officials