Optimizing Psychosocial Treatment of Interstitial Cystitis/Bladder Pain Syndrome

  • STATUS
    Recruiting
  • End date
    Mar 31, 2023
  • participants needed
    96
  • sponsor
    Vanderbilt University Medical Center
Updated on 15 February 2021
pain syndromes
bladder pain
cystitis
physical symptoms
pain disorders

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.

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.

Details
Condition prostatitis, Prostatic disorder, Interstitial Cystitis, Prostate Disorders, Bladder Pain Syndrome, Chronic Prostatitis, Interstitial Cystitis (Chronic) With Hematuria, Interstitial Cystitis (Chronic) Without Hematuria, Interstitial Cystitis (Chronic) With Hematuria, Interstitial Cystitis (Chronic) Without Hematuria, chronic interstitial cystitis, painful bladder syndrome, Interstitial Cystitis (Chronic) With Hematuria, Interstitial Cystitis (Chronic) Without Hematuria, Interstitial Cystitis (Chronic) With Hematuria, Interstitial Cystitis (Chronic) Without Hematuria
Treatment Attention Control, Psychosocial Treatment
Clinical Study IdentifierNCT04275297
SponsorVanderbilt University Medical Center
Last Modified on15 February 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Prostate Disorders or Interstitial Cystitis (Chronic) Without Hematuria or Interstitial Cystitis (Chronic) With Hematuria or Prostatic disorder or pro...?
Do you have any of these conditions: painful bladder syndrome or Prostatic disorder or Interstitial Cystitis or chronic interstitial cystitis or Interstitial Cystitis (Chronic) With Hemat...?
Do you have any of these conditions: Interstitial Cystitis or Interstitial Cystitis (Chronic) Without Hematuria or painful bladder syndrome or Prostatic disorder or Bladder Pain Syndrome ...?
years of age or older
Diagnosis of IC/BPS as given by providers or indicated by assessments

Exclusion Criteria

Comorbid neurological conditions including spinal cord injury or systematic neurologic illnesses, or central nervous system diseases such as brain tumor or stroke
Current or history of diagnosis of primary psychotic or major thought disorder within the past five years
Hospitalization for psychiatric reasons other than suicidal ideation, homicidal ideation, and/or PTSD (within the past 5 years)
Psychiatric or behavioral conditions in which symptoms are unstable or severe (e.g. current delirium, mania, psychosis, suicidal ideation, homicidal ideation, substance abuse dependency) reported within the past six months
Non-English speaking
Presenting symptoms at time of screening that would interfere with participation, specifically active suicidal ideation with intent to harm oneself or active delusional or psychotic thinking
Difficulties or limitations communicating over the telephone
Any planned life events that would interfere with participating in the key elements of the study
Any major active medical issues that could preclude participation
Currently being treated for cancer
Cancer-related pain
Currently engaged in individual counseling/psychotherapy or unwilling to pause this treatment for the trial duration
Clear my responses

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