Novel Web-based, Self-directed Intervention for Chronic Pelvic Pain

NCT06352840 | Completed Results

• 2 other identifiers: HUM002315265K23HD099283-03
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

The study is being completed to evaluate the effectiveness of a web-based, self-management program for patients with Chronic Pelvic Pain (CPP). The overall hypothesis is that patients with chronic pelvic pain that have access to the My Pelvic Plan program will demonstrate improvements in pain, physical function, and quality of life with this integrative self-management approach.

Conditions

Chronic Pelvic Pain; Endometriosis

Keywords

Quality of life; Cognitive Behavioral Therapy

Outcome Measures

Primary Outcomes (3)

• Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference Short Form (SF) 4a Between Groups

  There are four questions that participants will answer from not at all (1) - very much (5). The raw data was then converted to a t-score based on a population mean of 50 and standard deviation of 10, with higher scores above 50 meaning more interference and lower scores below 50 meaning less interference.

  3 months

• PROMIS Pain Intensity 1a Between Groups

  There is one question that participants will answer no pain (0) - worst pain (10). The raw data was then converted to a t-score based on a population mean of 50 and standard deviation of 10, with higher scores above 50 meaning higher pain intensity and lower scores below 50 meaning lower pain intensity.

  3 months

• PROMIS Self Efficacy for Managing Symptoms SF 4a Between Groups

  There are four questions that participants will answer from I am not all confident (1) - I am very confident (5). The raw data was then converted to a t-score based on a population mean of 50 and standard deviation of 10, with higher scores above 50 meaning more confidence in managing symptoms and lower scores below 50 meaning less confidence.

  3 months

Secondary Outcomes (3)

• Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference Short Form (SF) 4a Between Groups

  6 months

• PROMIS Pain Intensity 1a Between Groups

  6 months

• PROMIS Self Efficacy for Managing Symptoms SF 4a Between Groups

  6 months

Study Arms (2)

Monitoring progress plus usual care

OTHER

Participants will have access to the monitoring progress web-based symptom monitoring program.

Behavioral: Control Group website

My Pelvic Plan plus usual care

EXPERIMENTAL

Participants will have access to My Pelvic Plan program.

Behavioral: My Pelvic Plan Website

Interventions

My Pelvic Plan Website BEHAVIORAL

This is a self-directed program which integrates patient education about conditions that frequently contribute to pelvic pain, as well as instruction on cognitive and behavioral restructuring, self-administration of acupressure, engaging in physical activity, and a brief introduction to pelvic floor physical therapy techniques. Participants will have open access to the program over the 6-month intervention period. The intervention will be comprised of an active (12-week) phase and a maintenance (3-month) phase. Participants will receive a weekly text or email prompt directing patients to a specific module. All participants will receive prompts to the same modules for the first four weeks of the study, then during the next 8 weeks, participants will receive prompts to modules that corresponded to the most impactful symptoms on participant's baseline questionnaires. Following 12-week active phase, all participants will enter the maintenance phase.

My Pelvic Plan plus usual care

Control Group website BEHAVIORAL

Patients in the control group will undergo an active control intervention in which participants receive open access to a separate website that contains only the Monitoring Progress symptom tracker subpage over the 6-month study period. Control group participation will also be divided into an active (12-week) phase and a maintenance (3-month) phase. Similar to the intervention group, the control group will receive a weekly text (first 12 weeks) or email prompt directing them to a specific module or portion of the respective website. During the maintenance phase of the study, participants will receive monthly prompts to the Monitoring Progress subpage (without prompting to a specific symptom or activity).

Monitoring progress plus usual care

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Woman (female sex assigned at birth, may include cis-gender, trans-gender, nonbinary)
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants have chronic pelvic pain, defined by the protocol for ≥ 6-month duration, and is non-cyclic, occurring for at least 14 days of each month.
• Must be currently receiving care within Department of Obstetrics and Gynecology at the University of Michigan for treatment of chronic pelvic pain
• Access to internet via computer or smartphone
• English-language proficiency (current version of the website is in English)

You may not qualify if:

• Underwent gynecologic surgery within 3 months of screening visit
• Plan to undergo gynecologic surgery within 6 months following screening visit
• Pregnant (self-reported) at time of screening visit. Will not exclude patients that become pregnant during the course of the study.
• Severe physical impairment precluding participating in internet-based program (for example, complete blindness or deafness)
• Current psychiatric disorder with history of psychosis (for example, schizophrenia, schizoaffective disorder, delusional disorder),
• Current suicidal ideation or suicide attempt within 2 years of screening visit. The study will screen for severe depression and suicidality at each questionnaire time point and have developed a robust triage and referral plan.

Sponsors & Collaborators

• University of Michigan: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Results Point of Contact

• Title: Sara Till
• Organization: University of Michigan

tillsa@med.umich.edu

734-232-1333

Study Officials

• Sara Till, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Both participants and outcome assessors will be blinded to study group assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Obstetrics and Gynecology

Study Record Dates

• First Submitted: April 2, 2024
• First Posted: April 8, 2024
• Study Start: June 20, 2024
• Primary Completion: January 23, 2025
• Study Completion: April 28, 2025
• Last Updated: February 13, 2026
• Results First Posted: February 13, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)