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NCT Number: NCT06549985

Interdisciplinary Group Care for the Treatment of Endometriosis-associated Pain

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

Recruiting

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Key information

Conditions

Endometriosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Pelvic Pain Signs and Symptoms Urogenital Diseases

Age range

18 year–48 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Patient Reported Outcomes Measurement Information System (PROMIS) pain interference Short Form (SF) 8a

    Time frame: Baseline, immediately after the intervention

    Validated, 8-question survey that assesses pain interference in daily activities

Other outcomes

  1. PROMIS pain interference SF 8a

    Time frame: Baseline, 6- and 12-months after the intervention

    Validated, 8-question survey that assesses pain interference in daily activities

  2. PROMIS pain intensity

    Time frame: Baseline, immediately after the intervention, 6- and 12-months after the intervention

    Validated, 3-question survey that measures pain intensity on a 1-5 scale over the past 7 days

  3. Endometriosis Health Profile-30

    Time frame: Baseline, immediately after the intervention, 6- and 12-months after the intervention

    Validated, 30-question endometriosis-related quality of life measure

  4. PROMIS Physical Function SF10a

    Time frame: Baseline, immediately after the intervention, 6- and 12-months after the intervention

    Validated, 10-questions survey that measures physical function such as walking, carrying groceries, and other activities of daily living

  5. PROMIS Anxiety SF7a

    Time frame: Baseline, immediately after the intervention, 6- and 12-months after the intervention

    Validated, 7-question survey that measures anxiety in past 7 days

  6. PROMIS Depression SF8b

    Time frame: Baseline, immediately after the intervention, 6- and 12-months after the intervention

    Validated, 8-question survey that measures depression in past 7 days

  7. Patient global impression of change

    Time frame: Immediately after the intervention, 6- and 12-months after the intervention

    Validated, 1-question survey on impression of change over time

Study contacts

Contact information is provided by the study sponsor or research team.

Jaime Strickland, MA

CONTACT

[email protected]

314-747-1390

Whitney Ross, MD

CONTACT

[email protected]

314-747-5470

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Official study title

Interdisciplinary Group Care for the Treatment of Endometriosis-associated Pain: the Peer Empowered Endometriosis Pain Support (PEEPS) Pilot Randomized Controlled Trial

Acronym: PEEPS RCT

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Aug 12, 2024
Registry last updated
Dec 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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