Clinical trial NCT06352840: Novel Web-based, Self-directed Intervention for Chronic Pelvic Pain
Official title: Novel Web-based, Self-directed Intervention for Chronic Pelvic Pain
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Chronic Pelvic Pain
Endometriosis
Keywords: Quality of life
Cognitive Behavioral Therapy
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2024-04-08
Enrollment: 125
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.
* 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.

Primary outcomes:
measure: Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference short form (SF) 4a between groups
timeFrame: 3 months
measure: PROMIS pain intensity 1a between groups
timeFrame: 3 months
measure: PROMIS Self Efficacy for Managing Symptoms SF 4a between groups
timeFrame: 3 months
Secondary outcomes:
measure: Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference short form (SF) 4a between groups
timeFrame: 6 months
measure: PROMIS pain intensity 1a between groups
timeFrame: 6 months
measure: PROMIS Self Efficacy for Managing Symptoms SF 4a between groups
timeFrame: 6 months
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Sara Till, MD
role: PRINCIPAL_INVESTIGATOR
References: