NCT04275297

Optimizing Psychosocial Treatment of Interstitial Cystitis/Bladder Pain Syndrome

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 78 (actual)
• Sponsor: Vanderbilt University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Interstitial cystitis/bladder pain syndrome (IC/BPS) is a debilitating, incurable, and costly pain condition affecting approximately 3-8 million individuals in the United States and is extremely challenging to treat. Evidence suggests psychosocial factors accompany and intensify the illness. Unaddressed psychosocial co-morbidities are associated with reduced functionality and poorer outcomes, which suggests that psychosocial symptoms and bladder-specific symptoms reinforce each other. While psychosocial self-management interventions have demonstrated efficacy for other pain conditions, the IC/BPS field lacks the gold standard - randomized controlled trials - studying these interventions. At the same time, the chronic pain field is adopting a new approach driven by mechanisms of illness and treatment. Growing evidence suggests that subgroups (called "phenotypes") of patients with IC/BPS respond differently to medical intervention. Presence of central sensitization (CS) largely defines patient subgroups and may be a biological factor affecting response to medical treatment. The overall goal of this project is to fully develop, optimize, and evaluate a patient-centered CBT self-management intervention specific to IC/BPS. To achieve this goal, we will develop (Aim 1) and test (Aim 2) an empirically-based psychosocial treatment for IC/BPS compared to attention control, while examining pain mechanisms and subgroup characteristics that may alter treatment response (Aim 3). We hypothesize that a) inclusion of a self-management intervention will be more effective than a control treatment for IC/BPS, and that b) treatment effects will be moderated by degree of psychological co-morbidity, presence of chronic overlapping pain conditions, and elevated central sensitization. Successful completion of these aims will determine whether the addition of a tailored self-management intervention for IC/BPS will improve outcomes compared to control, whether particular subgroups are more responsive to this intervention, and whether a biological mechanism (CS) influences treatment responsiveness.

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

Type	Name	Description
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.

Timeline

• Start date: 2020-07-13
• Primary completion: 2022-06-16
• Completion: 2023-06-16
• First posted: 2020-02-19
• Last updated: 2023-08-08
• Results posted: 2023-08-08

Locations

1 site across 1 country: United States