Menu
Recruiting NCT06549985

Interdisciplinary Group Care for the Treatment of Endometriosis-associated Pain

No phase Interventional Endometriosis Pelvic Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: PEEPS, Education.
Who it may be relevant to
Registry conditions: Endometriosis, Pelvic Pain. Basic parameters: 18 years — 48 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Interventions

  • Behavioral PEEPS
    Participants will participate in the PEEPS program in addition to usual care.
  • Behavioral Education
    Participants will receive an educational handout on endometriosis in addition to usual care.

Primary outcome measures

  • Patient Reported Outcomes Measurement Information System (PROMIS) pain interference Short Form (SF) 8a [Time frame: Baseline, immediately after the intervention]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • WashU Medicine — St Louis

Publications

  • 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

Identifiers

NCT: NCT06549985 · 202402082

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗