EndometriosisPEEPS RCTNCT06549985
Interdisciplinary Group Care for the Treatment of Endometriosis-associated Pain
A study testing PEEPS and Education in people with Endometriosis and Pelvic Pain, run by Washington University School of Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 48 years, women only
- Conditions the study is for
- Endometriosis, Pelvic Pain
- What is being tested?
- PEEPS and Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Mar 2025to 30 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 48 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
WashU Medicine
St Louis, Missouri, 63108
MIGS Research Team, 3142731898, MIGSresearch@wustl.edu
Whitney Trotter Ross, MD, 3147475470, ross.w@email.wustl.edu
About this study
Official title: 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?
Read more
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
- Being tested
- PEEPS, Education
- Keywords
- Group care, Integrative care, Pelvic floor physical therapy, Mindfulness, Patient-centered outcomes
- Medical subject headings
- Endometriosis, Pelvic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEEPSBehavioural
Participants will participate in the PEEPS program in addition to usual care.
EducationBehavioural
Participants will receive an educational handout on endometriosis in addition to usual care.
| Study group | Role | What they receive |
|---|---|---|
| Peer Empowered Endometriosis Pain Support (PEEPS) | Experimental | 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. Receives: Behavioral: PEEPS |
| Education | Active comparator | Participants in this arm will receive an educational handout providing the basics of endometriosis pathophysiology, diagnosis, and treatment plus usual care Receives: Behavioral: Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Reported Outcomes Measurement Information System (PROMIS) pain interference Short Form (SF) 8a
Validated, 8-question survey that assesses pain interference in daily activities
Measured: Baseline, immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2024
- Study start17 Mar 2025
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Whitney Ross, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06549985
- Sponsor's protocol ID
- 202402082
- Acronym
- PEEPS RCT
- Status last verified
- Dec 2025
- First submitted
- 5 Aug 2024
- Last updated
- 26 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
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.
PubMed 40044193
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interdisciplinary Group Care for the Treatment of Endometriosis-associated Pain: the Peer Empowered Endometriosis Pain Support (PEEPS) Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06549985
- Acronym / sponsor ID
- PEEPS RCT / 202402082
- Conditions
- Endometriosis, Pelvic Pain
- Keywords
- Group care, Integrative care, Pelvic floor physical therapy, Mindfulness, Patient-centered outcomes
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 17 Mar 2025 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 12 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peer Empowered Endometriosis Pain Support (PEEPS) | Experimental | Behavioral: PEEPSParticipants 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. |
| Education | Active comparator | Behavioral: EducationParticipants in this arm will receive an educational handout providing the basics of endometriosis pathophysiology, diagnosis, and treatment plus usual care |
Who may qualify
- Ages
- 18 to 48 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PEEPSParticipants will participate in the PEEPS program in addition to usual care. | Behavioural | Peer Empowered Endometriosis Pain Support (PEEPS) |
| EducationParticipants will receive an educational handout on endometriosis in addition to usual care. | Behavioural | Education |
Primary outcome
Patient Reported Outcomes Measurement Information System (PROMIS) pain interference Short Form (SF) 8a
Time frame: Baseline, immediately after the intervention
Validated, 8-question survey that assesses pain interference in daily activities
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2025.
- Derived from this study: PubMed 40044193Ross 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Whitney Ross, MD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PEEPS and Education in people with Endometriosis and Pelvic Pain, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Whitney Ross, MD (314-747-5470, ross.w@email.wustl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Reported Outcomes Measurement Information System (PROMIS) pain interference Short Form (SF) 8a (time frame: Baseline, immediately after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06549985, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2025.