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EPPIC: Easing Pelvic Pain Interventions Clinical Research Program (EPPIC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05127616
Recruitment Status : Not yet recruiting
First Posted : November 19, 2021
Last Update Posted : November 19, 2021
Sponsor:
Collaborators:
University of California, Los Angeles
University of Michigan
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Jeffrey Lackner, State University of New York at Buffalo

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Urologic Chronic Pelvic Pain Syndrome (UCPPS) Interstitial Cystitis Bladder Pain Syndrome Chronic Prostatitis Chronic Pain Chronic Pelvic Pain Syndrome Chronic Overlapping Pain Disorders Behavioral: Minimal Contact-Cognitive Behavior Therapy Behavioral: Patient Education/Support Phase 2 Phase 3

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Brief, Transdiagnostic Cognitive Behavioral Treatment for Urological Chronic Pelvic Pain Syndrome: Processes, Predictions, Outcomes
Estimated Study Start Date : January 1, 2022
Estimated Primary Completion Date : October 2026
Estimated Study Completion Date : October 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pelvic Pain

Arm Intervention/treatment
Experimental: Minimal Contact-Cognitive Behavior Therapy
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
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.
Other Name: MC-CBT

Active Comparator: Education/Support
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 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.
Other Name: EDU




Primary Outcome Measures :
  1. Clinical Global Impressions - Improvement Scale Patient Version (CGI-I) [ Time Frame: 12 weeks after pre-treatment baseline ]
    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)


Secondary Outcome Measures :
  1. Genitourinary Pain Index (GUPI) [ Time Frame: Baseline, 12 weeks after pre treatment baseline, 3- and 6-month follow-up ]
    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)

  2. Interstitial Cystitis Problem Index (ICPI) [ Time Frame: Baseline, 12 weeks after pre treatment baseline, 3- and 6-month follow-up ]
    4-item questionnaire assessing problems caused by urinary and pelvic pain symptoms

  3. Interstitial Cystitis Symptom Index (ICSI) [ Time Frame: Baseline, 12 weeks after pre treatment baseline, 3- and 6-month follow-up ]
    4-item questionnaire of urinary and pelvic pain symptoms

  4. Brief Symptom Inventory (BSI 18) [ Time Frame: Baseline, 12 weeks after pre treatment baseline, 3- and 6-month follow-up ]
    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

  5. PROMIS - Pain Interference SF-6a [ Time Frame: Baseline, 12 weeks after pre treatment baseline, 3- and 6-month follow-up ]
    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

  6. Client Satisfaction Questionnaire (CSQ) [ Time Frame: 12 weeks after pre treatment baseline ]
    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


Other Outcome Measures:
  1. PROMIS - Fatigue SF-7a [ Time Frame: Baseline, 12 weeks after pre treatment baseline, 3- and 6-month follow-up ]
    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

  2. PROMIS Scale v1.2-Global Health Physical 2a [ Time Frame: Baseline, 12 weeks after pre treatment baseline, 3- and 6-month follow-up ]
    2-item measure of global physical health

  3. PROMIS Scale v1.2-Global Health Mental 2a [ Time Frame: Baseline, 12 weeks after pre treatment baseline, 3- and 6-month follow-up ]
    2-item measure of global mental health

  4. Beck Depression Inventory - II (BDI-II) [ Time Frame: Baseline, 12 weeks after pre treatment baseline, 3- and 6-month follow-up ]
    21-item criteria-referenced questionnaire of depressive severity. The BDI is aan IMMPACT-recommended measure.

  5. SF-12 Health Survey [ Time Frame: Baseline, 12 weeks after pre treatment baseline, 3- and 6-month follow-up ]
    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

  6. Change from baseline of the PROMIS - Sleep Disturbance SF-8b [ Time Frame: Baseline, 12 weeks after pre treatment baseline, 3- and 6-month follow-up ]
    8-item measure of perceptions of sleep quality, sleep depth, and restoration associated with sleep. Sleep is an IMMPACT-recommended endpoint



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 4-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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05127616


Contacts
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Contact: Jeffrey Lackner, PsyD 716-898-5671 lackner@buffalo.edu
Contact: Rebecca Firth, MHA 716-898-6254 rsfirth@buffalo.edu

Locations
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United States, California
UCLA
Los Angeles, California, United States, 90095-7378
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109-5330
Contact: J. Quentin Clemens, MD         
United States, New York
University at Buffalo
Buffalo, New York, United States, 14215
Contact: Rebecca Firth, MHA    716-898-6254    rsfirth@buffalo.edu   
Sponsors and Collaborators
State University of New York at Buffalo
University of California, Los Angeles
University of Michigan
National Institutes of Health (NIH)
Investigators
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Principal Investigator: Jeffrey Lackner, PsyD University at Buffalo (SUNY)
Publications:
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Responsible Party: Jeffrey Lackner, Professor, Chief Division of Behavioral Medicine, Dept of Medicine, State University of New York at Buffalo
ClinicalTrials.gov Identifier: NCT05127616    
Other Study ID Numbers: STUDY00005691
NIH Grant/1R01DK128927 ( Other Grant/Funding Number: NIH )
First Posted: November 19, 2021    Key Record Dates
Last Update Posted: November 19, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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 Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cystitis
Cystitis, Interstitial
Prostatitis
Syndrome
Chronic Pain
Pelvic Pain
Somatoform Disorders
Disease
Pathologic Processes
Pain
Neurologic Manifestations
Mental Disorders
Urinary Bladder Diseases
Urologic Diseases
Prostatic Diseases