EPPIC: Easing Pelvic Pain Interventions Clinical Research Program
EPPIC
A Brief, Transdiagnostic Cognitive Behavioral Treatment for Urological Chronic Pelvic Pain Syndrome: Processes, Predictions, Outcomes
2 other identifiers
interventional
240
1 country
3
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2022
Longer than P75 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 4, 2021
CompletedFirst Posted
Study publicly available on registry
November 19, 2021
CompletedStudy Start
First participant enrolled
August 10, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 31, 2028
January 26, 2026
January 1, 2026
5.5 years
November 4, 2021
January 22, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Clinical Global Impressions - Improvement Scale Patient Version (CGI-I)
Widely used measure of global improvement of symptoms from baseline. To optimize rigor, clinician version by independent MD assessors "blind" to treatment assignment will also measure global severity of pelvic pain and urinary symptoms from baseline and validate patient-reported global improvement as a marker of clinical response. Global improvement is a core domain recommended for conducting clinical trials of the efficacy and effectiveness of treatments for chronic pain according to Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT)
12 weeks after pre-treatment baseline
Secondary Outcomes (6)
Genitourinary Pain Index (GUPI)
Baseline, 12 weeks after pre treatment baseline, 3- and 6-month follow-up
Interstitial Cystitis Problem Index (ICPI)
Baseline, 12 weeks after pre treatment baseline, 3- and 6-month follow-up
Interstitial Cystitis Symptom Index (ICSI)
Baseline, 12 weeks after pre treatment baseline, 3- and 6-month follow-up
Brief Symptom Inventory (BSI 18)
Baseline, 12 weeks after pre treatment baseline, 3- and 6-month follow-up
PROMIS - Pain Interference SF-6a
Baseline, 12 weeks after pre treatment baseline, 3- and 6-month follow-up
- +1 more secondary outcomes
Other Outcomes (6)
PROMIS - Fatigue SF-7a
Baseline, 12 weeks after pre treatment baseline, 3- and 6-month follow-up
PROMIS Scale v1.2-Global Health Physical 2a
Baseline, 12 weeks after pre treatment baseline, 3- and 6-month follow-up
PROMIS Scale v1.2-Global Health Mental 2a
Baseline, 12 weeks after pre treatment baseline, 3- and 6-month follow-up
- +3 more other outcomes
Study Arms (2)
Minimal Contact-Cognitive Behavior Therapy
EXPERIMENTALCBT is a goal-focused, learning-based treatment that teaches practical self-management tools and strategies targeting biobehavioral factors that aggravate pelvic pain and urinary symptoms
Education/Support
ACTIVE COMPARATOREDU emphasizes the empowering therapeutic benefits that come from the common across empirically-validated drug or non-drug treatment such as being listened to, support, receipt of science-based information, mobilization of hope, and the establishment of a strong patient-doctor relationship working toward shared goals
Interventions
This 4 session largely home-based version of CBT with minimal therapist contact treatment is aimed at improving UCPPS symptoms by teaching symptom self-management skills that modify illness beliefs, information processing strategies, and reactions that aggravate pelvic pain and urinary symptoms.
This 4 session largely home-based treatment is aimed at improving UCPPS symptoms through the provision of support and science-based information about UCPPS symptoms, how it is diagnosed, its causes, impacts, and triggers, treatment options and a collaborative relationship between the patient and clinician.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Presence of a neurological condition (e.g., MS, Parkinson's disease, paraplegia) affecting the bladder
- The presence of a symptomatic urethral stricture (males only)
- History of cystitis caused by tuberculosis or radiation or chemotherapies
- Participant has been diagnosed and treated for a pelvic-related malignancy (colon, bladder, prostate, ovarian, endometrial, uterine, testicular, penile, cervical, vaginal, or rectal cancer)
- Participant has a medical condition(s) whose nature or severity (unstable, life threatening, etc.) would influence adversely the conduct of the clinical trial, confound interpretation of study results, and/or compromise volunteer safety and engagement with study demands.
- Gross cognitive impairment, deafness, blindness, vision problems (severe), hearing problems (severe)
- Has a major psychiatric disorder which would impede conduct of the clinical study. These clinical disorders would include but are not limited to major depression with a high risk of suicidal behavior (i.e. intent or plan), current or recent (within the past 3 months) history of alcohol or substance abuse/dependence, a lifetime history of schizophrenia or schizoaffective disorder; or organic mental disorder
- Current involvement in psychotherapy directed specifically toward relief of urological symptoms
- Schedule does not permit participation in clinic sessions or home practice including plans to move out of the area, lack of reliable transportation, etc.
- Characteristics related to inability to complete the study protocol
- Unable to read or fluently speak English
- Inability to complete screening visits
- Inaccessible for interventions and/or follow up evaluations
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- State University of New York at Buffalolead
- University of California, Los Angelescollaborator
- University of Michigancollaborator
Study Sites (3)
UCLA
Los Angeles, California, 90095-7378, United States
University of Michigan
Ann Arbor, Michigan, 48109-5330, United States
University at Buffalo (the only clinical site where treatment is delivered)
Buffalo, New York, 14215, United States
Related Publications (3)
Clemens JQ, Mullins C, Ackerman AL, Bavendam T, van Bokhoven A, Ellingson BM, Harte SE, Kutch JJ, Lai HH, Martucci KT, Moldwin R, Naliboff BD, Pontari MA, Sutcliffe S, Landis JR; MAPP Research Network Study Group. Urologic chronic pelvic pain syndrome: insights from the MAPP Research Network. Nat Rev Urol. 2019 Mar;16(3):187-200. doi: 10.1038/s41585-018-0135-5.
PMID: 30560936BACKGROUNDLeue C, Kruimel J, Vrijens D, Masclee A, van Os J, van Koeveringe G. Functional urological disorders: a sensitized defence response in the bladder-gut-brain axis. Nat Rev Urol. 2017 Mar;14(3):153-163. doi: 10.1038/nrurol.2016.227. Epub 2016 Dec 6.
PMID: 27922040BACKGROUNDLackner JM, Jaccard J, Quigley BM, Ablove TS, Danforth TL, Firth RS, Gudleski GD, Krasner SS, Radziwon CD, Vargovich AM, Clemens JQ, Naliboff BD. Study protocol and methods for Easing Pelvic Pain Interventions Clinical Research Program (EPPIC): a randomized clinical trial of brief, low-intensity, transdiagnostic cognitive behavioral therapy vs education/support for urologic chronic pelvic pain syndrome (UCPPS). Trials. 2022 Aug 13;23(1):651. doi: 10.1186/s13063-022-06554-9.
PMID: 35964133DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jeffrey Lackner, PsyD
University at Buffalo (SUNY)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, Chief Division of Behavioral Medicine, Dept of Medicine
Study Record Dates
First Submitted
November 4, 2021
First Posted
November 19, 2021
Study Start
August 10, 2022
Primary Completion (Estimated)
February 1, 2028
Study Completion (Estimated)
July 31, 2028
Last Updated
January 26, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- Data will be made made available within 6 months of the publication of each study aim for which data is sought from qualified investigators
Data will be made available for other researchers who wish to collaborate on specific analysis as requested after the investigators complete analyses and publication of study aims as well as to investigators who are conducting meta analyses. We will prepare detailed description of methods that make clear how the proposed study was rigorously executed and is reproducible.