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...

Overview

Journal Trials

Publisher Biomed Central

Specialties General Medicine
Pharmacology

Date 2022 Aug 13

PMID 35964133

Authors

Jeffrey M Lackner

James Jaccard

Brian M Quigley

Tova S Ablove

Teresa L Danforth

Rebecca S Firth

Gregory D Gudleski

Susan S Krasner

Christopher D Radziwon

Alison M Vargovich

J Quentin Clemens

Bruce D Naliboff

Affiliations

Soon will be listed here.

Abstract

Background: 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 with conventional medical therapies. Behavioral strategies, recommended as a first-line treatment for managing symptoms, are largely inaccessible, time and labor intensive, and technically complex. The Easing Pelvic Pain Interventions Clinical Research Program (EPPIC) is a clinical trial examining the efficacy of low-intensity cognitive behavioral therapy (Minimal Contact CBT or MC-CBT) for UCPPS and its durability 3 and 6 months post treatment. Additional aims include characterizing the operative processes (e.g., cognitive distancing, context sensitivity, coping flexibility, repetitive negative thought) that drive MC-CBT-induced symptom relief and pre-treatment patient variables that moderate differential response.

Methods: UCPPS patients (240) ages 18-70 years, any gender, ethnicity, and race, will be randomized to 4-session MC-CBT or a credible, non-specific education comparator (EDU) that controls for the generic effects from simply going to treatment. Efficacy assessments will be administered at pre-treatment, 2 weeks, and 3 and 6 months post treatment-week acute phase. A novel statistical approach applied to micro-analytic mediator assessment schedule will permit the specification of the most effective CBT component(s) that drive symptom relief.

Discussion: Empirical validation of a low-intensity self-management therapy transdiagnostic in scope has the potential to improve the health of chronic pelvic pain patients refractory to medical therapies, reduce social and economic costs, conserve health care resources, as well as inform evidence-based practice guidelines. Identification of change mechanisms and moderators of treatment effects can provide proactive patient-treatment matching fundamental to goals of personalized medicine.

Trial Registration: Clinicaltrials.gov NCT05127616. Registered on 9/19/21.

Citing Articles

Therapeutic Approaches for Urologic Chronic Pelvic Pain Syndrome; Management: Research Advances, Experimental Targets, and Future Directions.

Ashraf S, Clarkson T, Malykhina A J Pharmacol Exp Ther. 2024; 390(2):222-232.

PMID: 38565309 PMC: 11264256. DOI: 10.1124/jpet.123.002081.

Cognitive Behavioral Therapy for Chronic Pelvic Pain: What Is It and Does It Work?.

Lackner J, Clemens J, Radziwon C, Danforth T, Ablove T, Krasner S J Urol. 2024; 211(4):539-550.

PMID: 38228093 PMC: 10939861. DOI: 10.1097/JU.0000000000003847.

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