Clinical trial NCT05622955: Endometriosis Group Care
Official title: A Novel Approach to Endometriosis Treatment: Piloting an Interdisciplinary Group Care Model
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Endometriosis
Pelvic Pain
Keywords: Group care
Integrative care
Pelvic floor physical therapy
Yoga
Mindfulness
Patient-centered outcomes
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2022-11-21
Enrollment: 33
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 48
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to test the effectiveness of the Peer Empowered Endometriosis Pain Support (PEEPS) program in people living with endometriosis-related pelvic pain. The main question\[s\] it aims to answer are:

* Is PEEPS effective at decreasing pain interference and improving patient-reported quality of life outcomes?
* What are the barriers and facilitators to PEEPS implementation? Participants will engage in eight weekly 2-hour sessions led by an endometriosis specialist, pain psychologist, pelvic floor physical therapist, and yoga instructor. At these sessions they will participate in peer support, education, mindfulness, and yoga.

Detailed description: This is an 8 week interdisciplinary, integrative group care program conducted through the Department of Obstetrics and Gynecology (OB/GYN) at Washington University in St. Louis (WUSTL). The program, called PEEPS, incorporates mindfulness, physical therapy, yoga, physical activity, nutrition, and education. Additionally, PEEPS will provide peer support and demonstrate investment of individual clinicians and the healthcare system.

The program focuses on equipping participants with pain management and coping skills so they have an expanded toolkit to manage their pain after completing the program.

Eligibility criteria: Inclusion Criteria:

* Age 18-48 years
* Operative confirmation of endometriosis
* Chronic pelvic pain (defined as pain perceived to originate from the pelvis, lasting ≥6 months)
* No plan to have surgery in next 12 weeks
* Be able to attend eight 2-hour weekly sessions on the Washington University campus

Exclusion Criteria:

* Non-English speaking
* Currently pregnant
* Severe physical impairment
* History of hip or spine surgery
* Opioid use ≥ 5 days in the past 3 months, other than for the 6-week post-operative period
* Current or history of psychiatric disorder with psychosis
* Vulvadynia or vaginismus

Primary outcomes:
measure: Pain Interference
timeFrame: 8 weeks
Secondary outcomes:
measure: Physical Function
timeFrame: 8 weeks
measure: Sexual Function
timeFrame: 8 weeks
measure: Endometriosis-specific quality of life
timeFrame: 8 weeks
measure: Anxiety
timeFrame: 8 weeks
measure: Depression
timeFrame: 8 weeks
measure: Pain Catastrophizing
timeFrame: 8 weeks
measure: Overall symptom improvement
timeFrame: 8 weeks
measure: Modified every day discrimination scale
timeFrame: Baseline
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University in St. Louis
state: Missouri
Study officials:
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