An interventional study of Minimal Contact-Cognitive Behavior Therapy and Patient Education/Support in Urologic Chronic Pelvic Pain Syndrome (UCPPS), Interstitial Cystitis and Bladder Pain Syndrome, sponsored by State University of New York at Buffalo. Recruiting at 3 sites in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-10-13.
Sponsored by State University of New York at Buffalo · Not applicable, Interventional, and Treatment
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.
Urologic chronic pelvic pain syndrome (UCPPS) encompasses several common, costly diagnoses including interstitial cystitis/bladder pain syndrome and chronic prostatitis/chronic pelvic pain syndrome that are poorly understood and inadequately treated. Their prolonged personal and economic costs are amplified by the frequent co-occurrence of a cluster of centralized pain conditions (particularly irritable bowel syndrome 3 [IBS]) but also fibromyalgia [FMS], chronic headache, chronic fatigue, etc.) called Chronic Overlapping Pain Conditions (COPC). Clinically, the notion that these syndromes share a centralized pain phenotype with a fundamental disturbance in pain or sensory processing dovetails with our preliminary research showing that a novel transdiagnostic behavioral treatment emphasizing a single common mechanistic pathway (i.e. inflexible cognitive style) reduces severity of both targeted (IBS) and untargeted multisymptom COPCs that include (but is not limited to) to UCPPS, FMS, chronic fatigue, and chronic headache. If effective in a larger scale study, a transdiagnostic UCPPS treatment would offer a more efficient, accessible, and broadly useful strategy for improving chronic pelvic pain and its most frequent and complicating comorbidities. To this end, the investigators will randomize 240 UCPPS subjects (18-70 yrs.) of any gender and race to a 4-session version of CBT that teaches skills for self-managing UCPPS symptoms (e.g. pelvic pain, urinary symptoms such as urinary frequency, urgency) with minimal clinician oversight (MC-CBT) or a four-session non-specific education/support control (EDU). Efficacy assessments will be administered at pre-treatment baseline and two weeks after the end of the 10-week acute phase using the patient version of the Clinical Global Impressions Scale and validated with the physician version rated by MD assessors blind to treatment assignment. The investigators hypothesize MC-CBT will deliver significantly greater UCPPS symptom improvement than EDU (Aim 1). Additional aims include characterizing the durability of effects 3- and 6 months post treatment (Aim 2). To increase the efficacy and efficiency of behavioral pain treatments, the investigators draw upon Beck's transdiagnostic cognitive model to characterize the precise cognitive procedures and corresponding operative processes (e.g., cognitive distancing, context sensitivity, coping flexibility, repetitive negative thought) that drive MC-CBT induced UCPPS symptom relief relative to EDU (Aim 3) as well as baseline patient variables that moderate differential response (Aim 3) with the ultimate goal of more proactive patient-treatment matching fundamental to the goals of personalized medicine. By applying innovative statistical modelling (e.g. dominance analysis, Randomized Explanatory Trial analyses) to study aims in the context of a rigorously designed behavioral trial, the researchers expand the portfolio of nondrug pain treatments for UCPPS and co-aggregating COPCs to include one whose brevity, convenience, and transdiagnostic design "meets patients where they are" and addresses the practical (access, complexity, cost), clinical (breadth, durability, magnitude of effects, patient preference) and conceptual (untargeted comorbidities, non-pain somatic symptoms) challenges that have impeded uptake and public health impact of evidence-based behavioral pain treatments at a time when our most vulnerable high impact pain patients are in greatest need.
236 studies on the registry are indexed under Cystitis, Interstitial; 35 are open to participants now.
This study's planned enrollment of 240 is above the median of 51 across 158 interventional studies indexed under Cystitis, Interstitial.
Browse Cystitis, Interstitial studies →State University of New York at Buffalo is the lead sponsor of 294 studies on the registry; 63 are open to participants now.
Of its 19 completed or terminated interventional studies of FDA-regulated products, 15 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Exclusion Criteria: Urologic-Specific
Exclusion Criteria: General
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CBT 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
Behavioral: Minimal Contact-Cognitive Behavior Therapy
EDU 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
Behavioral: Patient Education/Support
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.
Also known as: MC-CBT
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.
Also known as: EDU
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)
Time frame: 12 weeks after pre-treatment baseline
Genitourinary Pain Index (GUPI)
9-item instrument of genitourinary pain including three subscales: pain, urinary, quality of life, and a total score. The GUPI includes a pain rating scale (assessed by a 0 to 10 numerical rating scale) which is a core outcome 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)
Time frame: Baseline, 12 weeks after pre treatment baseline, 3- and 6-month follow-up
Interstitial Cystitis Problem Index (ICPI)
4-item questionnaire assessing problems caused by urinary and pelvic pain symptoms
Time frame: Baseline, 12 weeks after pre treatment baseline, 3- and 6-month follow-up
Interstitial Cystitis Symptom Index (ICSI)
4-item questionnaire of urinary and pelvic pain symptoms
Time frame: Baseline, 12 weeks after pre treatment baseline, 3- and 6-month follow-up
Brief Symptom Inventory (BSI 18)
18-item measure of anxiety, depression, somatization and overall distress. Emotional distress is a core IMMPACT domain recommended for conducting clinical trials of the efficacy and effectiveness of treatments for chronic pain
Time frame: Baseline, 12 weeks after pre treatment baseline, 3- and 6-month follow-up
PROMIS - Pain Interference SF-6a
6-item measure of consequences of pain on relevant aspects of one's life, including the extent to which pain hinders engagement with social, cognitive, emotional, physical, and recreational activities. Physical functioning is a core IMMPACT domain recommended for conducting clinical trials of the efficacy and effectiveness of treatments for chronic pain
Time frame: Baseline, 12 weeks after pre treatment baseline, 3- and 6-month follow-up
Client Satisfaction Questionnaire (CSQ)
8-item questionnaire of patient satisfaction with treatment services. Patient satisfaction is a core IMMPACT domain recommended for conducting clinical trials of the efficacy and effectiveness of treatments for chronic pain
Time frame: 12 weeks after pre treatment baseline
CHOIR Body Map
The CHOIR Body Map is a self-report measure designed to assess the degree of widespread pain. Participants are presented with a body figure (male or female) containing 36 anterior segments and 38 posterior segments on which the participants can endorse areas of pain. A total score is calculated by summing the number of endorsed areas of pain (range: 0 - 74).
Time frame: Baseline, 12 weeks after pre-treatment baseline, 3- and 6-month follow-up
PROMIS - Fatigue SF-7a
7-item measure of range of symptoms, from mild subjective feelings of tiredness to an overwhelming, debilitating, and sustained sense of exhaustion that likely decreases one's ability to execute daily activities and function normally in family or social roles. Fatigue is an IMMPACT-recommended endpoint
Time frame: Baseline, 12 weeks after pre treatment baseline, 3- and 6-month follow-up
PROMIS Scale v1.2-Global Health Physical 2a
2-item measure of global physical health
Time frame: Baseline, 12 weeks after pre treatment baseline, 3- and 6-month follow-up
PROMIS Scale v1.2-Global Health Mental 2a
2-item measure of global mental health
Time frame: Baseline, 12 weeks after pre treatment baseline, 3- and 6-month follow-up
Beck Depression Inventory - II (BDI-II)
21-item criteria-referenced questionnaire of depressive severity. The BDI is aan IMMPACT-recommended measure.
Time frame: Baseline, 12 weeks after pre treatment baseline, 3- and 6-month follow-up
SF-12 Health Survey
12-item generic QOL measure of eight domains of health (physical functioning, role limitations from physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations resulting from emotional problems, mental health). The SF-12 include an IMMPACT-recommended role functioning item
Time frame: Baseline, 12 weeks after pre treatment baseline, 3- and 6-month follow-up
Change from baseline of the PROMIS - Sleep Disturbance SF-8b
8-item measure of perceptions of sleep quality, sleep depth, and restoration associated with sleep. Sleep is an IMMPACT-recommended endpoint
Time frame: Baseline, 12 weeks after pre treatment baseline, 3- and 6-month follow-up
Not enrolling at this site.
Not enrolling at this site.
Plan to share: Yes — 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.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
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
Started Aug 2022 (actual). Primary completion is estimated for Feb 2028, 66 months after the start.
Of 35 non-industry interventional studies with no phase under Cystitis, Interstitial, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 34. This study's planned 66 months is above that.
Counting every sponsor, half of 39 studies reached it within 23 months; a quarter within 16 and three quarters within 38.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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State University of New York at Buffalo →