A Brief, Transdiagnostic Cognitive Behavioral Treatment for Urological Chronic Pelvic Pain Syndrome: Processes, Predictions, Outcomes

Who is this study for? Patients with Chronic Pain
Status: Recruiting
Location: See all (3) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• 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 2-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

Locations
United States
California
UCLA
ACTIVE_NOT_RECRUITING
Los Angeles
Michigan
University of Michigan
ACTIVE_NOT_RECRUITING
Ann Arbor
New York
University at Buffalo (the only clinical site where treatment is delivered)
RECRUITING
Buffalo
Contact Information
Primary
Jeffrey Lackner, PsyD
lackner@buffalo.edu
716-898-5671
Backup
Patricia O'Leary, EdM
pcoleary@buffalo.edu
716-898-6254
Time Frame
Start Date: 2022-08-10
Estimated Completion Date: 2026-05-31
Participants
Target number of participants: 240
Treatments
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
Sponsors
Collaborators: University of Michigan, University of California, Los Angeles
Leads: State University of New York at Buffalo

This content was sourced from clinicaltrials.gov