EndometriosisPEEPSNCT05622955

Endometriosis Group Care

A study testing Peer Empowered Endometriosis Pain Support (PEEPS) in people with Endometriosis and Pelvic Pain, run by Washington University School of Medicine at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

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. Read more about this study

Who is it for?: Ages 18 to 48 years, women only
Conditions the study is for: Endometriosis, Pelvic Pain
What is being tested?: Peer Empowered Endometriosis Pain Support (PEEPS)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 35 participants
Where: 1 siteUnited States
Study dates: 20 Feb 2023to 26 Sep 2025
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 48 years
Women only
No healthy volunteers
Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Washington University in St. Louis
St Louis, Missouri, 63110

Other trials in United States

About this study

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

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.

Read the detailed 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.

Conditions: Endometriosis, Pelvic Pain
Being tested: Peer Empowered Endometriosis Pain Support (PEEPS)
Keywords: Group care, Integrative care, Pelvic floor physical therapy, Yoga, Mindfulness, Patient-centered outcomes
Medical subject headings: Endometriosis, Pelvic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Peer Empowered Endometriosis Pain Support (PEEPS)Other
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

Study groups in NCT05622955
Study group	Role	What they receive
Endometriosis group care	Experimental	Groups of 6-10 patients with endometriosis and chronic pelvic pain will attend eight weekly two-hour sessions. Receives: Other: Peer Empowered Endometriosis Pain Support (PEEPS)

What is being measured

The primary outcome is the main question the study is designed to answer.

PROMIS Pain Interference SF 8a
Change in pain interference at completion of the intervention (8-weeks) as compared to baseline is reported. Analysis was conducted using mixed-effects modeling. PROMIS measures are reported with T-scores using a mean of 50 and a standard deviation (SD) of 10, based on the U.S. general population. Higher score indicates more of the measure (i.e. more pain).
Measured: 8 weeks

Secondary outcomes (7)

PROMIS Physical Function SF10a
Change in physical function at completion of the intervention (8-weeks) as compared to baseline is reported. Analysis was conducted using mixed-effects modeling. PROMIS measures are reported with T-scores using a mean of 50 and a standard deviation (SD) of 10, based on the U.S. general population. Higher score indicates more of the measure (i.e. more/better physical function).
Measured: 8 weeks
Female Sexual Function Index
Change in reported sexual function, measured by the Female Sexual Function Index. 19-question validated survey administered to participants who endorsed being sexually active. Composite score is reported. The Scale Score Range is from 2.0 to 36.0 with higher score indicating better sexual function.
Measured: 8 weeks
Endometriosis Health Profile-30
Change in endometriosis-specific quality of life (measured by Endometriosis Health Profile-30) at completion of the intervention (8-weeks) as compared to baseline is reported. Analysis was conducted using mixed-effects modeling. This is a 30-question survey with 5 sub-domains. Composite score is reported. The score range is from 0 (best possible health status) to 100 (worst possible health status measured by the questionnaire). Lower scores mean better health.
Measured: 8 weeks
PROMIS Anxiety SF7a
Change in anxiety at completion of the intervention (8-weeks) as compared to baseline is reported. Analysis was conducted using mixed-effects modeling. PROMIS measures are reported with T-scores using a mean of 50 and a standard deviation (SD) of 10, based on the U.S. general population. Higher score indicates more of the measure (i.e. more anxiety).
Measured: 8 weeks
PROMIS Depression SF8b
Change in depression at completion of the intervention (8-weeks) as compared to baseline is reported. Analysis was conducted using mixed-effects modeling. PROMIS measures are reported with T-scores using a mean of 50 and a standard deviation (SD) of 10, based on the U.S. general population. Higher score indicates more of the measure (i.e. more depression). Lower score indicates symptom improvement.
Measured: 8 weeks
Patient Global Impression of Change (PGIC)
Percentage of Participants Reporting Improved Symptoms at PEEPS completetion measured by the Patient Global Impression of Change Scale. A score of 6 or greater indicates clinically significant improvement in symptoms.
Measured: 8 weeks
Modified Every Day Discrimination Scale
To assess experiences of healthcare discrimination, this Modified Every Day Discrimination Scale was administered at baseline. It is a validated survey that assesses experience of discrimination in 10 potential domains. Percentage of participants reporting experiencing discrimination "at least a few times per year" or more frequently is reported.
Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Feb 202326 Sep 2025

First posted21 Nov 2022
Study start20 Feb 2023
Primary completion26 Dec 2024
Study completion26 Sep 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (57)Papers the sponsor has linked to this study.
Other trials for EndometriosisStudies of the same condition, open and under way.
More trials run by Washington University School of MedicineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 35 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05622955
Sponsor's protocol ID: 202206202
Acronym: PEEPS
Status last verified: Feb 2026
First submitted: 10 Nov 2022
Last updated: 6 Mar 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Mowers EL, Lim CS, Skinner B, Mahnert N, Kamdar N, Morgan DM, As-Sanie S. Prevalence of Endometriosis During Abdominal or Laparoscopic Hysterectomy for Chronic Pelvic Pain. Obstet Gynecol. 2016 Jun;127(6):1045-1053. doi: 10.1097/AOG.0000000000001422.
PubMed 27159755
Missmer SA, Cramer DW. The epidemiology of endometriosis. Obstet Gynecol Clin North Am. 2003 Mar;30(1):1-19, vii. doi: 10.1016/s0889-8545(02)00050-5.
PubMed 12699255
As-Sanie S, Black R, Giudice LC, Gray Valbrun T, Gupta J, Jones B, Laufer MR, Milspaw AT, Missmer SA, Norman A, Taylor RN, Wallace K, Williams Z, Yong PJ, Nebel RA. Assessing research gaps and unmet needs in endometriosis. Am J Obstet Gynecol. 2019 Aug;221(2):86-94. doi: 10.1016/j.ajog.2019.02.033. Epub 2019 Feb 18.
PubMed 30790565
Walker EA, Katon WJ, Hansom J, Harrop-Griffiths J, Holm L, Jones ML, Hickok LR, Russo J. Psychiatric diagnoses and sexual victimization in women with chronic pelvic pain. Psychosomatics. 1995 Nov-Dec;36(6):531-40. doi: 10.1016/S0033-3182(95)71608-5.
PubMed 7501783
Meltzer-Brody S, Leserman J, Zolnoun D, Steege J, Green E, Teich A. Trauma and posttraumatic stress disorder in women with chronic pelvic pain. Obstet Gynecol. 2007 Apr;109(4):902-8. doi: 10.1097/01.AOG.0000258296.35538.88.
PubMed 17400852
Latthe P, Mignini L, Gray R, Hills R, Khan K. Factors predisposing women to chronic pelvic pain: systematic review. BMJ. 2006 Apr 1;332(7544):749-55. doi: 10.1136/bmj.38748.697465.55. Epub 2006 Feb 16.
PubMed 16484239
Fourquet J, Sinaii N, Stratton P, Khayel F, Alvarez-Garriga C, Bayona M, Ballweg ML, Flores I. Characteristics of women with endometriosis from the USA and Puerto Rico. J Endometr Pelvic Pain Disord. 2015 Oct-Dec;7(4):129-135. doi: 10.5301/je.5000224. Epub 2015 Oct 1.
PubMed 27331050
Delanerolle G, Ramakrishnan R, Hapangama D, Zeng Y, Shetty A, Elneil S, Chong S, Hirsch M, Oyewole M, Phiri P, Elliot K, Kothari T, Rogers B, Sandle N, Haque N, Pluchino N, Silem M, O'Hara R, Hull ML, Majumder K, Shi JQ, Raymont V. A systematic review and meta-analysis of the Endometriosis and Mental-Health Sequelae; The ELEMI Project. Womens Health (Lond). 2021 Jan-Dec;17:17455065211019717. doi: 10.1177/17455065211019717.
PubMed 34053382
Falcone T, Flyckt R. Clinical Management of Endometriosis. Obstet Gynecol. 2018 Mar;131(3):557-571. doi: 10.1097/AOG.0000000000002469.
PubMed 29420391
Williams AC, Eccleston C, Morley S. Psychological therapies for the management of chronic pain (excluding headache) in adults. Cochrane Database Syst Rev. 2012 Nov 14;11(11):CD007407. doi: 10.1002/14651858.CD007407.pub3.
PubMed 23152245
Geneen LJ, Moore RA, Clarke C, Martin D, Colvin LA, Smith BH. Physical activity and exercise for chronic pain in adults: an overview of Cochrane Reviews. Cochrane Database Syst Rev. 2017 Apr 24;4(4):CD011279. doi: 10.1002/14651858.CD011279.pub3.
PubMed 28436583
Smith CA, Armour M, Zhu X, Li X, Lu ZY, Song J. Acupuncture for dysmenorrhoea. Cochrane Database Syst Rev. 2016 Apr 18;4(4):CD007854. doi: 10.1002/14651858.CD007854.pub3.
PubMed 27087494
Monticone M, Ambrosini E, Rocca B, Cazzaniga D, Liquori V, Pedrocchi A, Vernon H. Group-based multimodal exercises integrated with cognitive-behavioural therapy improve disability, pain and quality of life of subjects with chronic neck pain: a randomized controlled trial with one-year follow-up. Clin Rehabil. 2017 Jun;31(6):742-752. doi: 10.1177/0269215516651979. Epub 2016 May 31.
PubMed 27246516
van Koulil S, van Lankveld W, Kraaimaat FW, van Helmond T, Vedder A, van Hoorn H, Donders R, de Jong AJ, Haverman JF, Korff KJ, van Riel PL, Cats HA, Evers AW. Tailored cognitive-behavioral therapy and exercise training for high-risk patients with fibromyalgia. Arthritis Care Res (Hoboken). 2010 Oct;62(10):1377-85. doi: 10.1002/acr.20268.
PubMed 20521308
Meissner K, Schweizer-Arau A, Limmer A, Preibisch C, Popovici RM, Lange I, de Oriol B, Beissner F. Psychotherapy With Somatosensory Stimulation for Endometriosis-Associated Pain: A Randomized Controlled Trial. Obstet Gynecol. 2016 Nov;128(5):1134-1142. doi: 10.1097/AOG.0000000000001691.
PubMed 27741200

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Novel Approach to Endometriosis Treatment: Piloting an Interdisciplinary Group Care Model
ClinicalTrials.gov ID: NCT05622955
Acronym / sponsor ID: PEEPS / 202206202
Conditions: Endometriosis, Pelvic Pain
Keywords: Group care, Integrative care, Pelvic floor physical therapy, Yoga, Mindfulness, Patient-centered outcomes
Study type: Interventional
Recruitment status: Completed
Enrolment: 35 participants (actual)
Lead sponsor: Washington University School of MedicineUniversity, hospital or other
Collaborators: National Institutes of Health (NIH)
Study start: 20 Feb 2023 (actual)
Primary completion: 26 Dec 2024 (actual)
Study completion: 26 Sep 2025 (actual)
First posted: 21 Nov 2022 (actual)
Results: Posted 6 Mar 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

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.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Endometriosis group care	Experimental	Other: Peer Empowered Endometriosis Pain Support (PEEPS)Groups of 6-10 patients with endometriosis and chronic pelvic pain will attend eight weekly two-hour sessions.

Who may qualify

Ages: 18 to 48 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (7 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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	Other	Endometriosis group care

Primary outcome

PROMIS Pain Interference SF 8a
Time frame: 8 weeks
Change in pain interference at completion of the intervention (8-weeks) as compared to baseline is reported. Analysis was conducted using mixed-effects modeling. PROMIS measures are reported with T-scores using a mean of 50 and a standard deviation (SD) of 10, based on the U.S. general population. Higher score indicates more of the measure (i.e. more pain).

7 secondary outcomes

PROMIS Physical Function SF10a
Time frame: 8 weeks
Female Sexual Function Index
Time frame: 8 weeks
Endometriosis Health Profile-30
Time frame: 8 weeks
PROMIS Anxiety SF7a
Time frame: 8 weeks
PROMIS Depression SF8b
Time frame: 8 weeks
Patient Global Impression of Change (PGIC)
Time frame: 8 weeks
Modified Every Day Discrimination Scale
Time frame: Baseline

Results and safety

Results posted to the registry on 6 Mar 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Endometriosis Group Care	35	32

Primary outcome: PROMIS Pain Interference SF 8a

Time frame: 8 weeks. Least squares mean (Standard Error). Unit: t-score

Measure	Endometriosis Group Care n = 35
Value	-1.62 (1.37)

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: From start of study through 6 months post-intervention completion. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Endometriosis Group Care	0 of 35 (0%)	0 of 35 (0%)	0 of 35

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 27159755Mowers EL, Lim CS, Skinner B, Mahnert N, Kamdar N, Morgan DM, As-Sanie S. Prevalence of Endometriosis During Abdominal or Laparoscopic Hysterectomy for Chronic Pelvic Pain. Obstet Gynecol. 2016 Jun;127(6):1045-1053. doi: 10.1097/AOG.0000000000001422.
Background: PubMed 12699255Missmer SA, Cramer DW. The epidemiology of endometriosis. Obstet Gynecol Clin North Am. 2003 Mar;30(1):1-19, vii. doi: 10.1016/s0889-8545(02)00050-5.
Background: PubMed 30790565As-Sanie S, Black R, Giudice LC, Gray Valbrun T, Gupta J, Jones B, Laufer MR, Milspaw AT, Missmer SA, Norman A, Taylor RN, Wallace K, Williams Z, Yong PJ, Nebel RA. Assessing research gaps and unmet needs in endometriosis. Am J Obstet Gynecol. 2019 Aug;221(2):86-94. doi: 10.1016/j.ajog.2019.02.033. Epub 2019 Feb 18.
Background: PubMed 7501783Walker EA, Katon WJ, Hansom J, Harrop-Griffiths J, Holm L, Jones ML, Hickok LR, Russo J. Psychiatric diagnoses and sexual victimization in women with chronic pelvic pain. Psychosomatics. 1995 Nov-Dec;36(6):531-40. doi: 10.1016/S0033-3182(95)71608-5.
Background: PubMed 17400852Meltzer-Brody S, Leserman J, Zolnoun D, Steege J, Green E, Teich A. Trauma and posttraumatic stress disorder in women with chronic pelvic pain. Obstet Gynecol. 2007 Apr;109(4):902-8. doi: 10.1097/01.AOG.0000258296.35538.88.
Background: PubMed 16484239Latthe P, Mignini L, Gray R, Hills R, Khan K. Factors predisposing women to chronic pelvic pain: systematic review. BMJ. 2006 Apr 1;332(7544):749-55. doi: 10.1136/bmj.38748.697465.55. Epub 2006 Feb 16.
Background: PubMed 27331050Fourquet J, Sinaii N, Stratton P, Khayel F, Alvarez-Garriga C, Bayona M, Ballweg ML, Flores I. Characteristics of women with endometriosis from the USA and Puerto Rico. J Endometr Pelvic Pain Disord. 2015 Oct-Dec;7(4):129-135. doi: 10.5301/je.5000224. Epub 2015 Oct 1.
Background: PubMed 34053382Delanerolle G, Ramakrishnan R, Hapangama D, Zeng Y, Shetty A, Elneil S, Chong S, Hirsch M, Oyewole M, Phiri P, Elliot K, Kothari T, Rogers B, Sandle N, Haque N, Pluchino N, Silem M, O'Hara R, Hull ML, Majumder K, Shi JQ, Raymont V. A systematic review and meta-analysis of the Endometriosis and Mental-Health Sequelae; The ELEMI Project. Womens Health (Lond). 2021 Jan-Dec;17:17455065211019717. doi: 10.1177/17455065211019717.
Background: PubMed 29420391Falcone T, Flyckt R. Clinical Management of Endometriosis. Obstet Gynecol. 2018 Mar;131(3):557-571. doi: 10.1097/AOG.0000000000002469.
Background: PubMed 23152245Williams AC, Eccleston C, Morley S. Psychological therapies for the management of chronic pain (excluding headache) in adults. Cochrane Database Syst Rev. 2012 Nov 14;11(11):CD007407. doi: 10.1002/14651858.CD007407.pub3.
Background: PubMed 28436583Geneen LJ, Moore RA, Clarke C, Martin D, Colvin LA, Smith BH. Physical activity and exercise for chronic pain in adults: an overview of Cochrane Reviews. Cochrane Database Syst Rev. 2017 Apr 24;4(4):CD011279. doi: 10.1002/14651858.CD011279.pub3.
Background: PubMed 27087494Smith CA, Armour M, Zhu X, Li X, Lu ZY, Song J. Acupuncture for dysmenorrhoea. Cochrane Database Syst Rev. 2016 Apr 18;4(4):CD007854. doi: 10.1002/14651858.CD007854.pub3.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Peer Empowered Endometriosis Pain Support (PEEPS) in people with Endometriosis and Pelvic Pain, run by Washington University School of Medicine at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PROMIS Pain Interference SF 8a (time frame: 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05622955, which also lists 57 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2026.