Group Care Program for Endometriosis

(PEEPS Trial)

Not currently recruiting at 1 trial location

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new program called PEEPS (Peer Empowered Endometriosis Pain Support) to determine its effectiveness in reducing pain and improving life quality for individuals with endometriosis-related pelvic pain. Participants will attend sessions featuring peer support, education, mindfulness, and yoga, led by specialists such as a pain psychologist and yoga instructor. The trial also evaluates the feasibility of implementing PEEPS. It suits individuals with endometriosis confirmed by surgery, who have experienced pelvic pain for at least six months, and can attend sessions at Washington University. As an unphased trial, this study offers a unique opportunity to contribute to innovative support methods for managing endometriosis pain.

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.

What prior data suggests that the PEEPS program is safe for participants?

Research has shown that the Peer Empowered Endometriosis Pain Support (PEEPS) program effectively manages pelvic pain from endometriosis through group activities. These activities include peer support, education, mindfulness, and yoga over eight weekly sessions. The program is considered safe because it avoids drugs or surgery, which often carry more risks. Instead, it emphasizes peer interaction and yoga, which are generally safe and manageable. Available research reports no negative effects from these activities. Participants engage in exercises and discussions aimed at reducing pain and improving quality of life, all under professional guidance. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Peer Empowered Endometriosis Pain Support (PEEPS) program because it offers a fresh approach to managing endometriosis compared to traditional treatments like hormonal therapy or pain medication. Unlike these standard options, which often focus on symptom suppression, PEEPS centers around group care and peer support, fostering a community where patients can share experiences and coping strategies. This method emphasizes emotional and psychological support, potentially improving overall well-being and reducing feelings of isolation among participants. By addressing the social and emotional aspects of chronic pelvic pain, PEEPS might provide benefits beyond just physical symptom relief.

What evidence suggests that the PEEPS program is effective for endometriosis-related pelvic pain?

Research shows that the Peer Empowered Endometriosis Pain Support (PEEPS) program, which participants in this trial will experience, might help people with endometriosis-related pelvic pain manage their daily activities better. Past studies found that those who complete the PEEPS program often experience less pain and enjoy a better quality of life. The program consists of eight weekly sessions that include peer support, education, mindfulness, and yoga, all guided by experts. Early findings suggest these activities can effectively manage pain and enhance overall well-being. Although more research is needed to confirm these benefits, the initial results are encouraging. ^{1 2 3 4 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

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05622955

Study Details | NCT05622955 | Endometriosis Group Care The goal of this clinical trial is to test the effectiveness of the Peer Empowered Endometriosis Pain Support (PEEPS) program in people living with ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40044193/

protocol for a pilot randomised controlled trial at an urban ... We hypothesise that patients who complete the PEEPS programme will show a greater decrease in pain interference in daily activities at intervention completion.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06549985?cond=%22Pelvic%20Pain%22&aggFilters=status:not%20rec&rank=8

Study Details | NCT06549985 | Interdisciplinary Group ... PEEPS is comprised of eight weekly two-hour sessions delivered to groups of 6-10 participants. The sessions provide education on endometriosis, ...

4. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05622955/endometriosis-group-care

Endometriosis Group Care | Clinical Research Trial Listing The goal of this clinical trial is to test the effectiveness of the Peer Empowered Endometriosis Pain Support (PEEPS) program in people ...

5. bmjopen.bmj.com bmjopen.bmj.com/content/15/3/e097372

protocol for a pilot randomised controlled trial at an urban ... We hypothesise that patients who complete the PEEPS programme will show a greater decrease in pain interference in daily activities at intervention completion.

6. reporter.nih.gov reporter.nih.gov/search/-b9eiCOEWU2fXFweWZpITA/project-details/10887156

Project Details We hypothesize that PEEPS will lead to decreased endometriosis-associated pain interference, improved quality of life, and decreased pain catastrophizing. To ...