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Behavioral Intervention

Peer Empowered Endometriosis Pain Support for Endometriosis (PEEPS RCT Trial)

Saint Louis, MO

N/A

Recruiting

Led By Whitney Ross, MD

Research Sponsored by Washington University School of Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

* Age 18-48 years

* Chronic pelvic pain (pain perceived to originate from the pelvis, not exclusively during menses, lasting ≥6 months)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 6- and 12-months after the intervention

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to see if a program called Peer Empowered Endometriosis Pain Support (PEEPS) can help reduce pain in women with endometriosis-associated chronic pelvic pain. They will

Who is the study for?

This trial is for individuals aged 18-48 with surgically confirmed endometriosis and chronic pelvic pain lasting over six months. Participants must not plan surgery during the study, be able to attend at least six out of eight sessions in English on the Washington University campus.

What is being tested?

The trial tests Peer Empowered Endometriosis Pain Support (PEEPS), an 8-week program, against standard Education to see if it better reduces pain interference. It includes group care sessions, quality of life surveys before and after the program, and follow-ups at 6 and 12 months.

What are the potential side effects?

Since PEEPS is a support and education-based intervention rather than a medication or surgical treatment, no traditional side effects are expected. However, participants may experience emotional discomfort or fatigue from discussing personal health issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 48 years old.

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I have had pelvic pain not just during periods for over 6 months.

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My endometriosis was confirmed through surgery.

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I do not plan to have surgery before or during the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 6- and 12-months after the intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 6- and 12-months after the intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 6- and 12-months after the intervention for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Patient Reported Outcomes Measurement Information System (PROMIS) pain interference Short Form (SF) 8a

Other study objectives

Endometriosis Health Profile-30

Female Sexual Function Index

PROMIS Anxiety SF7a

+7 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Peer Empowered Endometriosis Pain Support (PEEPS)Experimental Treatment1 Intervention

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 II: EducationActive Control1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

PEEPS

2023

N/A

~30

0 / 4Eligibility criteria met