EPPIC: Easing Pelvic Pain Interventions Clinical Research Program

Part of paid clinical trials in Los Angeles, California.

Sponsor
State University of New York at Buffalo
Study ID
NCT05127616
Status
Recruiting
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Conditions

  • Bladder Pain Syndrome
  • Chronic Overlapping Pain Disorders
  • Chronic Pain
  • Chronic Pelvic Pain Syndrome
  • Chronic Prostatitis
  • Interstitial Cystitis
  • Urologic Chronic Pelvic Pain Syndrome (UCPPS)

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Minimal Contact-Cognitive Behavior Therapy — BEHAVIORAL
    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.
  • Patient Education/Support — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Aug 10, 2022
Status verified
Jan 2026
Primary completion
Feb 29, 2028
Completion
Jul 31, 2028

Study Design

Enrollment
240 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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
  • 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

Primary Outcome Measure

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

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
UCLALos AngelesCalifornia90095-7378-
University of MichiganAnn ArborMichigan48109-5330-
University at Buffalo (the only clinical site where treatment is delivered)BuffaloNew York14215
Patricia O'Leary, MS Ed
[email protected]
1(716)898-6254

Find similar trials in Los Angeles, CA

By research site
UCLA· Los Angeles, CAUniversity of Michigan· Ann Arbor, MIUniversity at Buffalo (the only clinical site where treatment is delivered)· Buffalo, NY

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