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Optimizing Psychosocial Treatment of Interstitial Cystitis/Bladder Pain Syndrome

NCT04275297 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2023-08-08

Study results available
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Summary

Interstitial cystitis/bladder pain syndrome (IC/BPS) is a severe pain condition affecting 3-8 million people in the United States lacking treatments that work. Emotional suffering is common in IC/BPS and known to make physical symptoms worse, and studies show patient sub-groups respond differently to treatment. By creating and testing a psychosocial intervention specific to IC/BPS, we will learn if this intervention improves patient wellness, who the intervention works best for, and how the body's pain processing influences outcomes.

Conditions

  • Chronic Interstitial Cystitis
  • Bladder Pain Syndrome
  • Cystitis, Interstitial
  • Painful Bladder Syndrome
  • Cystitis, Chronic Interstitial
  • Interstitial Cystitis
  • Interstitial Cystitis, Chronic
  • Interstitial Cystitis (Chronic) With Hematuria
  • Interstitial Cystitis (Chronic) Without Hematuria
  • Chronic Prostatitis
  • Chronic Prostatitis With Chronic Pelvic Pain Syndrome

Interventions

BEHAVIORAL

Psychosocial Treatment

The psychosocial intervention will consist of 8 weekly 50-minute individual visits with the assigned therapist.

BEHAVIORAL

Attention Control

The Attention Control will reflect a similar visit pattern and duration as intervention sessions.

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • Vanderbilt University Medical Center

    lead OTHER

Principal Investigators

  • Lindsey McKernan, PhD MPH · Vanderbilt University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-13
Primary Completion
2022-06-16
Completion
2023-06-16

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04275297 on ClinicalTrials.gov