Interdisciplinary Group Care for the Treatment of Endometriosis-associated Pain

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Washington University School of Medicine
Study ID
NCT06549985
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 48 Years
Healthy Volunteers
Not accepted

Interventions

  • PEEPS — BEHAVIORAL
    Participants will participate in the PEEPS program in addition to usual care.
  • Education — BEHAVIORAL
    Participants will receive an educational handout on endometriosis in addition to usual care.

Study Details

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

Key Dates

Start date
Mar 17, 2025
Status verified
Dec 2025
Primary completion
Sep 30, 2027
Completion
Sep 30, 2028

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • Active Comparator: Education
    Participants in this arm will receive an educational handout providing the basics of endometriosis pathophysiology, diagnosis, and treatment plus usual care

Primary Outcome Measure

Patient Reported Outcomes Measurement Information System (PROMIS) pain interference Short Form (SF) 8a [ Time Frame: Baseline, immediately after the intervention ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
WashU MedicineSt LouisMissouri63108
MIGS Research Team
[email protected]
3142731898
Whitney Trotter Ross, MD
[email protected]
3147475470
Whitney Ross, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in St Louis, MO

By condition
Endometriosis
By specialty
Women's healthFertility
By research site
WashU Medicine· St Louis, MO

Related Studies