PEEPS: Endometriosis Group Care

Sponsor

Washington University School of Medicine (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05622955

Collaborator

National Institutes of Health (NIH) (NIH)

Enrollment

Arm

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Endometriosis Pelvic Pain	Other: Peer Empowered Endometriosis Pain Support (PEEPS)	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Novel Approach to Endometriosis Treatment: Piloting an Interdisciplinary Group Care Model

Anticipated Study Start Date :

Jan 1, 2023

Anticipated Primary Completion Date :

Jul 1, 2024

Anticipated Study Completion Date :

Jan 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Endometriosis group care Groups of 6-10 patients with endometriosis and chronic pelvic pain will attend eight weekly two-hour sessions.	Other: Peer Empowered Endometriosis Pain Support (PEEPS) The sessions will provide education on endometriosis, mindfulness, yoga, nutrition, and strategies to cope with chronic pain. Patients will additionally receive peer and clinician support to decrease the social isolation experienced by people with endometriosis

Arm

Intervention/Treatment

Experimental: Endometriosis group care

Groups of 6-10 patients with endometriosis and chronic pelvic pain will attend eight weekly two-hour sessions.

Other: Peer Empowered Endometriosis Pain Support (PEEPS)

The sessions will provide education on endometriosis, mindfulness, yoga, nutrition, and strategies to cope with chronic pain. Patients will additionally receive peer and clinician support to decrease the social isolation experienced by people with endometriosis

Outcome Measures

Primary Outcome Measures

Pain Interference [8 weeks]
Change in reported pain after PEEPS program completion by Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference

Secondary Outcome Measures

Physical Function [8 weeks]
Change in reported physical function, measured by the PROMIS Physical Function Scale
Sexual Function [8 weeks]
Change in reported sexual function, measured by the Female Sexual Function Index
Endometriosis-specific quality of life [8 weeks]
Endometriosis-specific quality of life, measured by Endometriosis Health Profile-30
Anxiety [8 weeks]
Change in reported anxiety, measured by the PROMIS Anxiety Scale
Depression [8 weeks]
Change in reported depression, measured by the PROMIS Depression Scale
Pain Catastrophizing [8 weeks]
Change in reported catastrophizing, measured by the Pain Catastrophizing Scale
Overall symptom improvement [8 weeks]
Change in overall symptoms, measured by the Patient Global Impression of Change Scale
Modified every day discrimination scale [Baseline]
To assess experiences of healthcare discrimination

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 48 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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