Recruiting

Interdisciplinary Care

Sponsor:

Washington University School of Medicine

Code:

NCT06549985

Conditions

Endometriosis

Pelvic Pain

Eligibility Criteria

Sex: Female

Age: 18 - 48

Healthy Volunteers: Not accepted

Interventions

PEEPS

Education

Study Details

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

Study ID

NCT06549985

Start date

Mar 17, 2025

Status verified date

Dec, 2025

Completion date

Sep 30, 2028

Anticipated

Primary completion date

Sep 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 48

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

active comparator: Education

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

Interventions

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Locations

WashU Medicine

Recruiting

St Louis, Missouri, United States, 63108

Contacts

Principal Investigator:

Whitney Ross, MD

More Information

Sponsor

Washington University School of Medicine

Last update posted

Dec 26, 2025

Last verified

Dec, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Washington University School of Medicine on 2025-12-26.