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).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

35 participants

Primary outcome timeframe

8 weeks

Results posted on

2026-03-06

Participant Flow

Participant milestones

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
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

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 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).

Outcome measures

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 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).

Outcome measures

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 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.

Outcome measures

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

SECONDARY outcome

Timeframe: 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.

Outcome measures

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 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).

Outcome measures

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 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.

Outcome measures

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 Depression SF8b
-2.48 T-score
Standard Error 1.27

SECONDARY outcome

Timeframe: 8 weeks

Population: 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

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
Patient Global Impression of Change (PGIC)
37.5 percentage of participants

SECONDARY outcome

Timeframe: Baseline

Population: 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

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
Modified Every Day Discrimination Scale
67.6 percentage of participants

Adverse Events

Endometriosis Group Care

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Whitney Ross

WashU Medicine

Phone: 314-747-5470

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place