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)
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 the...
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| Format: | Article |
| Language: | English |
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BMC
2022-08-01
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| Series: | Trials |
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| Online Access: | https://doi.org/10.1186/s13063-022-06554-9 |
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| author | 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 |
| author_facet | 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 |
| author_sort | Jeffrey M. Lackner |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-04-13T13:09:57Z |
| format | Article |
| id | doaj.art-c2851a7443fb43089f4c5f8f18a72393 |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-04-13T13:09:57Z |
| publishDate | 2022-08-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-c2851a7443fb43089f4c5f8f18a723932022-12-22T02:45:39ZengBMCTrials1745-62152022-08-0123112010.1186/s13063-022-06554-9Study 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)Jeffrey M. Lackner0James Jaccard1Brian M. Quigley2Tova S. Ablove3Teresa L. Danforth4Rebecca S. Firth5Gregory D. Gudleski6Susan S. Krasner7Christopher D. Radziwon8Alison M. Vargovich9J. Quentin Clemens10Bruce D. Naliboff11Division of Behavioral Medicine, Department of Medicine, Jacobs School of Medicine, University at BuffaloSchool of Social Work, New York UniversityDivision of Behavioral Medicine, Department of Medicine, Jacobs School of Medicine, University at BuffaloDepartment of Obstetrics and Gynecology, Jacobs School of Medicine, University at BuffaloDepartment of Urology, Jacobs School of Medicine, University at BuffaloDivision of Behavioral Medicine, Department of Medicine, Jacobs School of Medicine, University at BuffaloDivision of Behavioral Medicine, Department of Medicine, Jacobs School of Medicine, University at BuffaloDivision of Behavioral Medicine, Department of Medicine, Jacobs School of Medicine, University at BuffaloDivision of Behavioral Medicine, Department of Medicine, Jacobs School of Medicine, University at BuffaloDivision of Behavioral Medicine, Department of Medicine, Jacobs School of Medicine, University at BuffaloDepartment of Urology, University of MichiganG. Oppenheimer Center for Neurobiology of Stress and Resilience, Department of Psychiatry and Biobehavioral Sciences, UCLAAbstract 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.https://doi.org/10.1186/s13063-022-06554-9Chronic painRandomized clinical trialTransdiagnosticChronic prostatitisInterstitial cystitisBladder pain syndrome |
| spellingShingle | 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 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 Chronic pain Randomized clinical trial Transdiagnostic Chronic prostatitis Interstitial cystitis Bladder pain syndrome |
| title | 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) |
| title_full | 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) |
| title_fullStr | 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) |
| title_full_unstemmed | 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) |
| title_short | 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) |
| title_sort | 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 |
| topic | Chronic pain Randomized clinical trial Transdiagnostic Chronic prostatitis Interstitial cystitis Bladder pain syndrome |
| url | https://doi.org/10.1186/s13063-022-06554-9 |
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