Clinical trial NCT04275297: Optimizing Psychosocial Treatment of Interstitial Cystitis/Bladder Pain Syndrome
Official title: Optimizing Psychosocial Treatment of Interstitial Cystitis/Bladder Pain Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Keywords: interstitial cystitis
bladder pain syndrome
clinical trial
psychosocial intervention
pelvic pain
therapy
urological chronic pelvic pain syndrome
chronic prostatitis
self-management
cognitive behavioral therapy
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2020-02-19
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study involves a two group parallel design, with one group receiving individual psychosocial intervention online/in person and another individual symptom monitoring and discussion via telephone.
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* 18 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

Primary outcomes:
measure: Change in the Genitourinary Pain Index (GUPI) 2 Months
timeFrame: baseline to 2 months
measure: Change in the Genitourinary Pain Index (GUPI) 5 Months
timeFrame: baseline to 5 months
Secondary outcomes:
measure: Change in Depressive Symptoms Measured by the Patient Health Questionnaire (PHQ-8)
timeFrame: baseline, 2 months (after treatment is complete), 5 months
measure: The Widespread Pain Index (Derived From CHOIR Bodymap)
timeFrame: baseline, 2 months (after treatment is complete), 5 months
measure: Fibromyalgia Symptom Scale (FSS)
timeFrame: baseline, 2 months (after treatment is complete), 5 months
measure: Change in Posttraumatic Stress Symptoms Measured by PTSD Checklist for DSM-5 (PCL-5) With Criterion A
timeFrame: baseline, 2 months (after treatment is complete), 5 months
measure: Change in Anxiety Symptoms Measured by the Generalized Anxiety Disorder (GAD-7) Questionnaire
timeFrame: baseline, 2 months (after treatment is complete), 5 months
measure: Difference in Response to Treatment/Perceived Improvement and Quality of Life Between Groups as Measured by the Patient Global Impression of Change Scale (PGIC)
timeFrame: 2 months (after treatment is complete), 5 months
measure: Quantitative Sensory Testing (Optional) - Threshold Average
timeFrame: baseline
measure: Quantitative Sensory Testing (Optional) - Tolerance Average
timeFrame: baseline
measure: Quantitative Sensory Testing - Temporal Summation (Slope)
timeFrame: Baseline
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Lindsey McKernan, PhD MPH
role: PRINCIPAL_INVESTIGATOR
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