NCT05622955

Brief Summary

The goal of this clinical trial is to test the effectiveness of the Peer Empowered Endometriosis Pain Support (PEEPS) program in people living with endometriosis-related pelvic pain. The main question\[s\] it aims to answer are:

  • Is PEEPS effective at decreasing pain interference and improving patient-reported quality of life outcomes?
  • What are the barriers and facilitators to PEEPS implementation? Participants will engage in eight weekly 2-hour sessions led by an endometriosis specialist, pain psychologist, pelvic floor physical therapist, and yoga instructor. At these sessions they will participate in peer support, education, mindfulness, and yoga.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 10, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 21, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

February 20, 2023

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 26, 2024

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 26, 2025

Completed
5 months until next milestone

Results Posted

Study results publicly available

March 6, 2026

Completed
Last Updated

March 6, 2026

Status Verified

February 1, 2026

Enrollment Period

1.8 years

First QC Date

November 10, 2022

Results QC Date

December 22, 2025

Last Update Submit

February 12, 2026

Conditions

Keywords

Group careIntegrative carePelvic floor physical therapyYogaMindfulnessPatient-centered outcomes

Outcome Measures

Primary Outcomes (1)

  • PROMIS Pain Interference SF 8a

    Change in pain interference at completion of the intervention (8-weeks) as compared to baseline is reported. Analysis was conducted using mixed-effects modeling. PROMIS measures are reported with T-scores using a mean of 50 and a standard deviation (SD) of 10, based on the U.S. general population. Higher score indicates more of the measure (i.e. more pain).

    8 weeks

Secondary Outcomes (7)

  • PROMIS Physical Function SF10a

    8 weeks

  • Female Sexual Function Index

    8 weeks

  • Endometriosis Health Profile-30

    8 weeks

  • PROMIS Anxiety SF7a

    8 weeks

  • PROMIS Depression SF8b

    8 weeks

  • +2 more secondary outcomes

Study Arms (1)

Endometriosis group care

EXPERIMENTAL

Groups of 6-10 patients with endometriosis and chronic pelvic pain will attend eight weekly two-hour sessions.

Other: Peer Empowered Endometriosis Pain Support (PEEPS)

Interventions

The sessions will provide education on endometriosis, mindfulness, yoga, nutrition, and strategies to cope with chronic pain. Patients will additionally receive peer and clinician support to decrease the social isolation experienced by people with endometriosis

Endometriosis group care

Eligibility Criteria

Age18 Years - 48 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age 18-48 years
  • Operative confirmation of endometriosis
  • Chronic pelvic pain (defined as pain perceived to originate from the pelvis, lasting ≥6 months)
  • No plan to have surgery in next 12 weeks
  • Be able to attend eight 2-hour weekly sessions on the Washington University campus

You may not qualify if:

  • Non-English speaking
  • Currently pregnant
  • Severe physical impairment
  • History of hip or spine surgery
  • Opioid use ≥ 5 days in the past 3 months, other than for the 6-week post-operative period
  • Current or history of psychiatric disorder with psychosis
  • Vulvadynia or vaginismus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University in St. Louis

St Louis, Missouri, 63110, United States

Location

Related Publications (57)

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MeSH Terms

Conditions

EndometriosisPelvic Pain

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Whitney Ross
Organization
WashU Medicine

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 10, 2022

First Posted

November 21, 2022

Study Start

February 20, 2023

Primary Completion

December 26, 2024

Study Completion

September 26, 2025

Last Updated

March 6, 2026

Results First Posted

March 6, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations