Interdisciplinary Group Care for the Treatment of Endometriosis-associated Pain

NCT ID: NCT06549985

Last Updated: 2025-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-17

Study Completion Date

2028-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Endometriosis Pelvic Pain

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

PEEPS

Intervention Type BEHAVIORAL

Participants will participate in the PEEPS program in addition to usual care.

Education

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

Group Type ACTIVE_COMPARATOR

Education

Intervention Type BEHAVIORAL

Participants will receive an educational handout on endometriosis in addition to usual care.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

PEEPS

Participants will participate in the PEEPS program in addition to usual care.

Intervention Type BEHAVIORAL

Education

Participants will receive an educational handout on endometriosis in addition to usual care.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

48 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Washington University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Whitney Ross, MD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

WashU Medicine

St Louis, Missouri, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Whitney Ross, MD

Role: CONTACT

Phone: 314-747-5470

Email: [email protected]

Jaime Strickland, MA

Role: CONTACT

Phone: 314-747-1390

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

MIGS Research Team

Role: primary

Whitney Trotter Ross, MD

Role: backup

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 40044193 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

202402082

Identifier Type: -

Identifier Source: org_study_id