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

Endometriosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06352840
• Other study ID #: HUM00231526
• Secondary ID: 5K23HD099283-03
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2024
• Est. completion date: April 2026

Study information

• Verified date: April 2024
• Source: University of Michigan
• Contact: Jordyn Boggan
• Phone: 269-760-7317
• Email: jboggan[@]umich.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 125
• Est. completion date: April 2026
• Est. primary completion date: April 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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.

• Currently undergoing cognitive behavioral therapy (in-person or virtual, conducted with a therapist) at time of screening visit

• 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.

Related Conditions & MeSH terms

• Chronic Pelvic Pain
• Endometriosis
• Pelvic Pain

Intervention

Behavioral:
• My Pelvic Plan Website
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.
• Control Group website
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).

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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). Scores range from 4-20, with higher scores meaning more interference.	3 months
Primary	PROMIS pain intensity 1a between groups	There is one question that participants will answer no pain (0) - worst pain (10). Lower score means less pain.	3 months
Primary	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). Scores range from 4-20, with higher scores meaning more confident.	3 months
Secondary	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). Scores range from 4-20, with higher scores meaning more interference.	6 months
Secondary	PROMIS pain intensity 1a between groups	There is one question that participants will answer no pain (0) - worst pain (10). Lower score means less pain.	6 months
Secondary	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). Scores range from 4-20, with higher scores meaning more confident.	6 months