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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Education | Active Comparator | Participants in this arm will receive an educational handout providing the basics of endometriosis pathophysiology, diagnosis, and treatment plus usual care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PEEPS | Behavioral | Participants will participate in the PEEPS program in addition to usual care. |
|
| 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 |
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| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Whitney Ross, MD | Contact | 314-747-5470 | ross.w@email.wustl.edu | |
| Jaime Strickland, MA | Contact | 314-747-1390 | jaime.strickland@wustl.edu |
| Name | Affiliation | Role |
|---|---|---|
| Whitney Ross, MD | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| WashU Medicine | Recruiting | St Louis | Missouri | 63108 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40044193 | Derived | 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. |
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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.
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.
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.
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| ID | Term |
|---|---|
| D004715 | Endometriosis |
| D017699 | Pelvic Pain |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D004522 | Educational Status |
| ID | Term |
|---|---|
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
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| Education | Behavioral | Participants will receive an educational handout on endometriosis in addition to usual care. |
|
| 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 |
| D000091662 | Genital Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |