Trial Outcomes & Findings for Endometriosis Group Care (NCT NCT05622955)
NCT ID: NCT05622955
Last Updated: 2026-03-06
Results Overview
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).
COMPLETED
NA
35 participants
8 weeks
2026-03-06
Participant Flow
Participant milestones
| Measure |
Endometriosis Group Care
Groups of 6-10 patients with endometriosis and chronic pelvic pain will attend eight weekly two-hour sessions.
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
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|---|---|
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Overall Study
STARTED
|
35
|
|
Overall Study
COMPLETED
|
32
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Endometriosis Group Care
Baseline characteristics by cohort
| Measure |
Endometriosis Group Care
n=35 Participants
Groups of 6-10 patients with endometriosis and chronic pelvic pain will attend eight weekly two-hour sessions.
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
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=41 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
35 Participants
n=41 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=41 Participants
|
|
Age, Continuous
|
33.5 year
STANDARD_DEVIATION 6.4 • n=41 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=41 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=41 Participants
|
|
Region of Enrollment
United States
|
35 participants
n=41 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=41 Participants
|
|
Race (NIH/OMB)
White
|
30 Participants
n=41 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=41 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=41 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
28 Participants
n=41 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=41 Participants
|
PRIMARY outcome
Timeframe: 8 weeksChange 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).
Outcome measures
| Measure |
Endometriosis Group Care
n=35 Participants
Groups of 6-10 patients with endometriosis and chronic pelvic pain will attend eight weekly two-hour sessions.
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
|
|---|---|
|
PROMIS Pain Interference SF 8a
|
-1.62 t-score
Standard Error 1.37
|
SECONDARY outcome
Timeframe: 8 weeksChange 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).
Outcome measures
| Measure |
Endometriosis Group Care
n=35 Participants
Groups of 6-10 patients with endometriosis and chronic pelvic pain will attend eight weekly two-hour sessions.
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
|
|---|---|
|
PROMIS Physical Function SF10a
|
1.12 t-score
Standard Error 0.98
|
SECONDARY outcome
Timeframe: 8 weeksChange 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.
Outcome measures
| Measure |
Endometriosis Group Care
n=35 Participants
Groups of 6-10 patients with endometriosis and chronic pelvic pain will attend eight weekly two-hour sessions.
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
|
|---|---|
|
Female Sexual Function Index
|
1.51 units on a scale
Standard Error 1.85
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SECONDARY outcome
Timeframe: 8 weeksChange 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.
Outcome measures
| Measure |
Endometriosis Group Care
n=35 Participants
Groups of 6-10 patients with endometriosis and chronic pelvic pain will attend eight weekly two-hour sessions.
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
|
|---|---|
|
Endometriosis Health Profile-30
|
-12.58 units on a scale
Standard Error 3.21
|
SECONDARY outcome
Timeframe: 8 weeksChange 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).
Outcome measures
| Measure |
Endometriosis Group Care
n=35 Participants
Groups of 6-10 patients with endometriosis and chronic pelvic pain will attend eight weekly two-hour sessions.
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
|
|---|---|
|
PROMIS Anxiety SF7a
|
-1.84 t-score
Standard Error 1.35
|
SECONDARY outcome
Timeframe: 8 weeksChange 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.
Outcome measures
| Measure |
Endometriosis Group Care
n=35 Participants
Groups of 6-10 patients with endometriosis and chronic pelvic pain will attend eight weekly two-hour sessions.
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
|
|---|---|
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PROMIS Depression SF8b
|
-2.48 T-score
Standard Error 1.27
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: 37.5% of PEEPS participants endorsed that their activity limitations, symptoms, emotions, and overall QOL related to endometriosis had become better or a great deal better (score of greater than or equal to 6) since beginning PEEPS.
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.
Outcome measures
| Measure |
Endometriosis Group Care
n=32 Participants
Groups of 6-10 patients with endometriosis and chronic pelvic pain will attend eight weekly two-hour sessions.
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
|
|---|---|
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Patient Global Impression of Change (PGIC)
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37.5 percentage of participants
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SECONDARY outcome
Timeframe: BaselinePopulation: 34 of 35 completed the measure. of these, 67.6% endorsed facing some kind of discrimination at least a few times a year.
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.
Outcome measures
| Measure |
Endometriosis Group Care
n=34 Participants
Groups of 6-10 patients with endometriosis and chronic pelvic pain will attend eight weekly two-hour sessions.
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
|
|---|---|
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Modified Every Day Discrimination Scale
|
67.6 percentage of participants
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Adverse Events
Endometriosis Group Care
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place