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.
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
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)
Parallel
Minimal Contact-Cognitive Behavior Therapy
BehavioralThis 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.
Patient Education/Support
BehavioralThis 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.
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)
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)
Interstitial Cystitis Problem Index (ICPI)
4-item questionnaire assessing problems caused by urinary and pelvic pain symptoms
Interstitial Cystitis Symptom Index (ICSI)
4-item questionnaire of urinary and pelvic pain symptoms
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
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
PROMIS Scale v1.2-Global Health Physical 2a
2-item measure of global physical health
PROMIS Scale v1.2-Global Health Mental 2a
2-item measure of global mental health
Beck Depression Inventory - II (BDI-II)
21-item criteria-referenced questionnaire of depressive severity. The BDI is aan IMMPACT-recommended measure.
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State University of New York at Buffalo
Lead sponsor
University of California, Los Angeles
Collaborator
University of Michigan
Collaborator
