A program to ease pelvic pain through cognitive behavioral therapy
Official title: A Brief, Transdiagnostic Cognitive Behavioral Treatment for Urological Chronic Pelvic Pain Syndrome: Processes, Predictions, Outcomes
Run by State University of New York at Buffalo · NCT05127616 · Data updated 2026-11-12
This study is testing a short program of cognitive behavioral therapy to see if it can help people with chronic pelvic pain feel better compared to regular patient education.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 70 Years |
| Sex | All |
| Enrollment | 240 (estimated) |
| Sponsor | State University of New York at Buffalo Academic / other |
| Drugs / interventions | radiation |
| Locations | 3 sites (Los Angeles, California and 2 other locations) |
| Status | Recruiting |
| Started | August 10, 2022 |
| Main results expected | February 2028 |
| Study ends | July 31, 2028 |
| Registry record updated | October 13, 2026 |
| Trial ID | NCT05127616 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18-70 with a confirmed diagnosis of interstitial cystitis or chronic prostatitis and experiencing moderate to severe pelvic pain.
✕Probably not a fit
Patients with acute pelvic pain or those not meeting the eligibility criteria may not benefit from this program.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The EPPIC program evaluates a brief, four-session cognitive behavioral therapy (CBT) designed for individuals suffering from urologic chronic pelvic pain syndrome (UCPPS). This innovative approach aims to address the common underlying mechanisms of pain across various conditions, including interstitial cystitis and chronic prostatitis. By focusing on a transdiagnostic treatment model, the program seeks to improve accessibility and efficiency in managing chronic pelvic pain and its associated comorbidities. Participants will be randomized to receive either the CBT intervention or standard patient education and support.
Why it matters
Potential benefit: If successful, this program could provide a more effective and accessible treatment option for patients suffering from chronic pelvic pain.
How similar studies have gone: Previous studies have shown promise in using cognitive behavioral therapy for chronic pain management, suggesting potential success for this novel approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
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, 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) Exclusion Criteria: General * 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
Where it's running
-
University at Buffalo (the only clinical site where treatment is delivered)
Buffalo, New York, United States Recruiting -
UCLA
Los Angeles, California, United States Active not recruiting -
University of Michigan
Ann Arbor, Michigan, United States Active not recruiting
Study contacts
- Principal investigator: Jeffrey Lackner, PsyD — University at Buffalo (SUNY)
- Study coordinator: Jeffrey Lackner, PsyD
- Email: lackner@buffalo.edu
- Phone: 716-898-5671
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.