- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05622955
Endometriosis Group Care (PEEPS)
A Novel Approach to Endometriosis Treatment: Piloting an Interdisciplinary Group Care Model
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Missouri
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St Louis, Missouri, United States, 63110
- Washington University in St. Louis
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Endometriosis group care
Groups of 6-10 patients with endometriosis and chronic pelvic pain will attend eight weekly two-hour sessions.
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).
|
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
PROMIS Physical Function SF10a
Time Frame: 8 weeks
|
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).
|
8 weeks
|
|
Female Sexual Function Index
Time Frame: 8 weeks
|
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.
|
8 weeks
|
|
Endometriosis Health Profile-30
Time Frame: 8 weeks
|
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.
|
8 weeks
|
|
PROMIS Anxiety SF7a
Time Frame: 8 weeks
|
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).
|
8 weeks
|
|
PROMIS Depression SF8b
Time Frame: 8 weeks
|
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.
|
8 weeks
|
|
Patient Global Impression of Change (PGIC)
Time Frame: 8 weeks
|
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.
|
8 weeks
|
|
Modified Every Day Discrimination Scale
Time Frame: Baseline
|
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.
|
Baseline
|
Collaborators and Investigators
Collaborators
Publications and helpful links
General Publications
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Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 202206202
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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