Interdisciplinary Group Care for the Treatment of Endometriosis-associated Pain (PEEPS RCT)

The Washington University

Status: Enrolling

Conditions: Pelvic Pain; Endometriosis

Treatments: Behavioral: PEEPS; Behavioral: Education

Study type: Interventional

Funder types: Other

Identifiers

NCT06549985

202402082

Details and patient eligibility

About

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

Enrollment: 60 estimated patients

Sex: Female

Ages: 18 to 48 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18-48 years
• Operative confirmation of endometriosis
• Chronic pelvic pain (pain perceived to originate from the pelvis, not exclusively during menses, lasting ≥6 months)
• No plan to have surgery before or during the PEEPS cohort
• Able to attend at least six of the eight 2-hour weekly sessions on the Washington University campus
• Comfort reading and speaking English as groups and materials are in English

Exclusion criteria

• Currently pregnant
• Severe physical impairment (limiting yoga participation)
• History of hip or spine surgery given increased risk of harm and need for extensive activity modification
• Current or history of psychiatric disorder with psychosis in order to minimize risk of adverse mental health effects to participants
• Opioid use ≥ 5 days in the past 3 months, other than for the 6-week post-operative period
• History of surgical removal of bilateral ovaries

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Peer Empowered Endometriosis Pain Support (PEEPS)

Experimental group

Description:

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.

Treatment:

Behavioral: PEEPS

Education

Active Comparator group

Description:

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

Treatment:

Behavioral: Education