Endometriosis Group Care

Endometriosis Clinical Trial

— PEEPS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05622955
• Other study ID #: 202206202
• Status: Recruiting
• Phase: N/A
• Start date: February 20, 2023
• Est. completion date: January 2025

Study information

• Verified date: October 2023
• Source: Washington University School of Medicine
• Contact: Whitney Ross, MD
• Phone: 314-747-5470
• Email: ross.w[@]email.wustl.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: January 2025
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 48 Years

Eligibility

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

Related Conditions & MeSH terms

• Endometriosis
• Pelvic Pain

Intervention

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

Locations

Country	Name	City	State
United States	Washington University in St. Louis	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

References & Publications (57)

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* Note: There are 57 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Interference	Change in reported pain after PEEPS program completion by Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference	8 weeks
Secondary	Physical Function	Change in reported physical function, measured by the PROMIS Physical Function Scale	8 weeks
Secondary	Sexual Function	Change in reported sexual function, measured by the Female Sexual Function Index	8 weeks
Secondary	Endometriosis-specific quality of life	Endometriosis-specific quality of life, measured by Endometriosis Health Profile-30	8 weeks
Secondary	Anxiety	Change in reported anxiety, measured by the PROMIS Anxiety Scale	8 weeks
Secondary	Depression	Change in reported depression, measured by the PROMIS Depression Scale	8 weeks
Secondary	Pain Catastrophizing	Change in reported catastrophizing, measured by the Pain Catastrophizing Scale	8 weeks
Secondary	Overall symptom improvement	Change in overall symptoms, measured by the Patient Global Impression of Change Scale	8 weeks
Secondary	Modified every day discrimination scale	To assess experiences of healthcare discrimination	Baseline