Interdisciplinary Group Care for the Treatment of Endometriosis-associated Pain (PEEPS RCT)

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

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

Study Overview

• Status: Recruiting
• Conditions: Endometriosis; Pelvic Pain
• Intervention / Treatment: Behavioral: PEEPS; Behavioral: Education

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Whitney Ross, MD; Phone Number: 314-747-5470; Email: ross.w@email.wustl.edu
• Study Contact Backup: Name: Jaime Strickland, MA; Phone Number: 314-747-1390; Email: jaime.strickland@wustl.edu

Study Locations

• United States
  • Missouri
    • St Louis, Missouri, United States, 63108
      • Recruiting
      • WashU Medicine
      • Contact: MIGS Research Team; Phone Number: 3142731898; Email: MIGSresearch@wustl.edu
      • Contact: Whitney Trotter Ross, MD; Phone Number: 3147475470; Email: ross.w@email.wustl.edu
      • Principal Investigator: Whitney Ross, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Behavioral: PEEPS; Participants will participate in the PEEPS program in addition to usual care.
Active Comparator: Education; Participants in this arm will receive an educational handout providing the basics of endometriosis pathophysiology, diagnosis, and treatment plus usual care	Behavioral: Education; Participants will receive an educational handout on endometriosis in addition to usual care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
PROMIS pain interference SF 8a	Validated, 8-question survey that assesses pain interference in daily activities	Baseline, 6- and 12-months after the intervention
PROMIS pain intensity	Validated, 3-question survey that measures pain intensity on a 1-5 scale over the past 7 days	Baseline, immediately after the intervention, 6- and 12-months after the intervention
Endometriosis Health Profile-30	Validated, 30-question endometriosis-related quality of life measure	Baseline, immediately after the intervention, 6- and 12-months after the intervention
PROMIS Physical Function SF10a	Validated, 10-questions survey that measures physical function such as walking, carrying groceries, and other activities of daily living	Baseline, immediately after the intervention, 6- and 12-months after the intervention
PROMIS Anxiety SF7a	Validated, 7-question survey that measures anxiety in past 7 days	Baseline, immediately after the intervention, 6- and 12-months after the intervention
PROMIS Depression SF8b	Validated, 8-question survey that measures depression in past 7 days	Baseline, immediately after the intervention, 6- and 12-months after the intervention
Patient global impression of change	Validated, 1-question survey on impression of change over time	Immediately after the intervention, 6- and 12-months after the intervention

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Investigators: Principal Investigator: Whitney Ross, MD, Washington University School of Medicine

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 17, 2025
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2028

Study Registration Dates

• First Submitted: August 5, 2024
• First Submitted That Met QC Criteria: August 8, 2024
• First Posted (Actual): August 12, 2024

Study Record Updates

• Last Update Posted (Actual): December 26, 2025
• Last Update Submitted That Met QC Criteria: December 18, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Mindfulness; Integrative care; Patient-centered outcomes; Pelvic floor physical therapy; Group care
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Pain; Neurologic Manifestations; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Diseases, Female; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Endometriosis; Pelvic Pain; Socioeconomic Factors; Population Characteristics; Educational Status
• Other Study ID Numbers: 202402082

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data will be preserved and shared through Digital Commons@Becker, an institutional repository administered and maintained by the Bernard Becker Medical Library at Washington University in St. Louis. All de-identified clinical, survey, and interview data from this project will be shared via Digital Commons@Becker of sufficient quality to validate and replicate research findings. Data dictionaries and study protocols will also be shared via Digital Commons@Becker.
• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No