EPPIC: Easing Pelvic Pain Interventions Clinical Research Program (NCT05127616) | Clinical Trial Compass
RecruitingNot Applicable
EPPIC: Easing Pelvic Pain Interventions Clinical Research Program
United States240 participantsStarted 2022-08-10
Plain-language summary
The EPPIC (Easing Pelvic Pain Interventions Clinical Research Program) study evaluates an ultra-brief, 4 session cognitive behavioral pain treatment transdiagnostic in design for urologic chronic pain syndrome (UCPPS) with clinical and practical advantages over existing behavioral therapies whose length and focus limits their adoption by clinicians and coverage for mechanistically similar comorbidities. A theoretically informed, practical, empirically grounded approach will systematically unpack CBT's working mechanisms, clarify for whom it works, ease dissemination, appeal to patients, providers, payers, and policy makers in the COVID-19 era favoring low resource intensity treatments, and reduce cost and inefficiencies associated with high intensity therapies whose complexity, length, and scarcity restricts uptake and impact.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Ages 18-70 years (inclusive)
* Male or female
* All genders, races, ethnic groups
* MD-confirmed diagnosis of IC/BPS or CP/CPPS by study urologist or urogynecologist
* Pelvic pain including uncomfortable sensations of pressure or discomfort that are not described as outright pain) of at least six months duration
* Pelvic pain intensity of at least moderate severity (defined as 3 or greater on a 0-10 Numerical Rating Scale and causes life interference weekly and limit(s) participant's life or work-related activities, general activity level, and/or enjoyment of life) over the past 3 months.
* Ability to understand and provide informed consent
* Either not taking medications or if taking medications willing to refrain from starting new medications until after the initial 2-week pre-treatment baseline period ends unless medically necessary.
* A minimum 6th grade reading level based on the Wide Range Achievement Test (WRAT 4)
* Willing to be randomized to either CBT or Support/Education and to follow the protocol to which s/he has been assigned
* Willing to be contacted for follow up assessments at week 12 and 3, 6 months after treatment ends
* Willing to attend sessions
* Able to maintain symptom diaries and complete paper work
* Access to telephone and computer or smartphone
* Willing and able to provide adequate information for locator purposes
Exclusion Criteria: Urologic-Specific
* Presence of a neurological condition (e.g., MS, Parkinson's disease, p…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Clinical Global Impressions - Improvement Scale Patient Version (CGI-I)