Group Care Program for Endometriosis

(PEEPS Trial)

Overseen By Jaime Strickland, MA

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Washington University School of Medicine

Must not be taking: Opioids

Disqualifiers: Pregnancy, Physical impairment, Psychiatric disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

Duration: 8 weeks

33 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. However, it does exclude those who have used opioids for 5 or more days in the past 3 months, except for a specific post-operative period.

How is the PEEPS treatment for endometriosis different from other treatments?

The PEEPS treatment is unique because it involves a group care program that focuses on peer support and empowerment, which can help women with endometriosis manage pain and depression more effectively by providing social support and shared experiences, unlike traditional medical treatments that primarily focus on medication or surgery. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment Peer Empowered Endometriosis Pain Support (PEEPS)?

The study on multi-professional group intervention for women with endometriosis showed improvements in pain and depression scores, suggesting that group-based support can be beneficial for managing endometriosis symptoms. ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

This trial is for individuals aged 18-48 with confirmed endometriosis and chronic pelvic pain, who can attend eight weekly sessions at Washington University. It's not suitable for those planning surgery within 12 weeks, non-English speakers, pregnant women, people with severe physical impairments or a history of hip/spine surgery, frequent opioid users (except post-surgery), or those with psychiatric disorders involving psychosis.

Inclusion Criteria

My endometriosis was confirmed through surgery.

I can attend eight 2-hour sessions at Washington University.

I have had pelvic pain for 6 months or more.

Exclusion Criteria

I have had surgery on my hip or spine.

I have used opioids for at least 5 days in the last 3 months, not counting the first 6 weeks after surgery.

I have pain in my vulva or difficulty with vaginal penetration.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in the PEEPS program, attending eight weekly 2-hour sessions led by specialists, focusing on peer support, education, mindfulness, and yoga.

8 weeks

8 visits (in-person)

Follow-up

Participants are monitored for changes in pain interference and quality of life after completing the PEEPS program.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Peer Empowered Endometriosis Pain Support (PEEPS)

Trial Overview The study tests the Peer Empowered Endometriosis Pain Support (PEEPS) program to see if it reduces pain interference and improves life quality in endometriosis patients. PEEPS includes peer support, education from specialists, mindfulness practices, and yoga over eight weekly sessions.

How Is the Trial Designed?

Group I: Endometriosis group care Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Published Research Related to This Trial

A study involving 128 women with endometriosis showed that those who participated in a multi-professional group intervention experienced significant reductions in both pain and depression scores after the intervention.

The results suggest that group intervention can be an effective complementary treatment for managing pain and depression in women with endometriosis, highlighting the importance of psychological support in their overall care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Evaluation of pain and depression in women with endometriosis after a multi- professional group intervention]. Lorençatto, C., Vieira, MJ., Marques, A., et al.[2019]

The Painful Periods Screening Tool (PPST) was found to significantly improve communication between patients and healthcare providers regarding pelvic pain symptoms, with 91.5% of participants believing it would help in discussions about their pain.

In a study involving 1000 participants, 82.9% reported severe pelvic pain during menstruation, and 70.7% felt more comfortable discussing their symptoms after using the PPST, highlighting its potential as a useful screening tool for conditions like endometriosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Utility and Impact of the Painful Periods Screening Tool (PPST) to Improve Healthcare Delivery for People with Symptoms of Pelvic Pain. Singh, B., Berry, J., Volovsky, M., et al.[2023]

Women with endometriosis highly value social support, particularly from peers who understand their condition, as revealed by a study involving 46 participants in an online support group.

The study highlights that these women seek knowledgeable support networks and desire their healthcare providers to facilitate connections to information and resources about endometriosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Importance of lay organizations for coping with endometriosis. Whitney, ML.[2015]

Citations

1. Brazil pubmed.ncbi.nlm.nih.gov

[Evaluation of pain and depression in women with endometriosis after a multi- professional group intervention]. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Hormonal suppression treatment or dietary therapy versus placebo in the control of painful symptoms after conservative surgery for endometriosis stage III-IV. A randomized comparative trial. [2013]

3. United States pubmed.ncbi.nlm.nih.gov

The Utility and Impact of the Painful Periods Screening Tool (PPST) to Improve Healthcare Delivery for People with Symptoms of Pelvic Pain. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

A stepped-care approach to symptomatic endometriosis management: a participatory research initiative. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Long-term treatment of endometriosis-related pain among women seeking hormonal contraception. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Importance of lay organizations for coping with endometriosis. [2015]