Optimizing Psychosocial Treatment of Interstitial Cystitis/Bladder Pain Syndrome

Study Overview
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Brief Summary
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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
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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.

Official Title
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Optimizing Psychosocial Treatment of Interstitial Cystitis/Bladder Pain Syndrome

Conditions
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Chronic Prostatitis, 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 With Chronic Pelvic Pain Syndrome

Intervention / Treatment
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* Behavioral: Psychosocial Treatment
* Behavioral: Attention Control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Psychosocial Treatment<br>The psychosocial self-management intervention consists of 8 weekly 50-minute individual visits with an assigned trained therapist. Sessions follow a structured protocol that has been developed with the patient population. Treatment modules are individualized and include topics such as pain coping strategies, relaxation training, education on IC/BPS, and communication strategies. | Behavioral: Psychosocial Treatment<br>* The psychosocial intervention will consist of 8 weekly 50-minute individual visits with the assigned therapist.<br>|
| Placebo Comparator: Attention Control<br>The attention control condition consists of 8 weekly telephone calls with a study interventionist. Sessions will occur via scheduled telephone calls and follow a structured procedure. Telephone calls are designed to monitor symptoms and overall wellness. Each week, participants will be asked about current symptoms, flare patterns, and physical and emotional wellbeing. | Behavioral: Attention Control<br>* The Attention Control will reflect a similar visit pattern and duration as intervention sessions.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the Genitourinary Pain Index (GUPI) 2 Months | The Genitourinary Pain Index measures genitourinary symptom severity in both men and women. It is comprised of three subscales: pain, urinary symptoms, and impact on quality of life. The total score ranges from 0-35, with 0 being the lowest severity of symptoms and 35 being the highest. | baseline to 2 months | 
| Change in the Genitourinary Pain Index (GUPI) 5 Months | The Genitourinary Pain Index measures genitourinary symptom severity in both men and women. It is comprised of three subscales: pain, urinary symptoms, and impact on quality of life. The total score ranges from 0-35, with 0 being the lowest severity of symptoms and 35 being the highest. | baseline to 5 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Depressive Symptoms Measured by the Patient Health Questionnaire (PHQ-8) | The eight-item Patient Health Questionnaire depression scale (PHQ-8) is established as a valid diagnostic and severity measure for depressive disorders in large clinical studies. It consists of 8 questions where participants indicate on a Likert scale the extent to which they have experienced symptoms of depression within the past two weeks, with 0 being not at all and 3 being nearly every day. Cumulative scores range from 0-24, with cutoff points for none, mild, moderate, moderately severe, and severe marked at 5, 10, 15, and 20. | baseline, 2 months (after treatment is complete), 5 months | 
| The Widespread Pain Index (Derived From CHOIR Bodymap) | The Widespread Pain Index measures the location(s) of chronic pain complaints and widespread body pain. Widespread pain was assessed using the Collaborative Health Outcomes Information Registry (CHOIR) bodymap, condensed into a Widespread Pain Index (WPI) score assessing 19 potential body pain areas. Scores on the WPI range from 0-19, with one point given for each potential body pain area endorsed; higher scores indicate higher widespread pain. The WPI was coupled with the Fibromyalgia Symptom Scale (FSS) below, a 7-item questionnaire, to calculate the American College of Rheumatology classification criteria for fibromyalgia, and assess fibromyalgia symptom severity (higher scores indicate higher symptom severity). The WPI total (0-19) can be combined with the FSS (0-12) in a sum total score (0-31) to assess the degree of a person's widespread pain and fibromyalgia symptom severity, with higher scores indicating a worse outcome. | baseline, 2 months (after treatment is complete), 5 months | 
| Fibromyalgia Symptom Scale (FSS) | 7-item questionnaire assessing modified 2010 American College of Rheumatology diagnostic criteria for fibromyalgia and includes a) an index of widespread pain and b) an index of symptom severity via patient self-report. The FSS is the index of symptom severity and can range from 0-12. Higher scores indicate higher symptom severity, a worse outcome. When combined with the WPI score above, a total score on this scale (WPI + FSS) ranges from 0-31, with scores ≥ 13 indicating a high likelihood of fibromyalgia. | baseline, 2 months (after treatment is complete), 5 months | 
| Change in Posttraumatic Stress Symptoms Measured by PTSD Checklist for DSM-5 (PCL-5) With Criterion A | The PTSD Checklist for the DSM-5 measures post-traumatic stress. It utilizes the symptom checklist for PTSD in the DSM-5 and inquires about trauma-induced thoughts and behaviors in the past month. The total score ranges from 0-80, with 31-33 and above indicating probable diagnosis of PTSD. | baseline, 2 months (after treatment is complete), 5 months | 
| Change in Anxiety Symptoms Measured by the Generalized Anxiety Disorder (GAD-7) Questionnaire | The Generalized Anxiety Disorder (GAD-7) questionnaire is a self-administered 7 item instrument that uses some of the DSM-V criteria for GAD to identify probable cases of GAD along with measuring anxiety symptom severity. Questions are on a 4-point Likert scale, with 0 being not at all sure and 3 being nearly every day. Cumulative scoring is tiered from minimal anxiety (0-4) to mild anxiety (5 to 9) to moderate anxiety (10-14) to severe anxiety (15-21). | baseline, 2 months (after treatment is complete), 5 months | 
| Difference in Response to Treatment/Perceived Improvement and Quality of Life Between Groups as Measured by the Patient Global Impression of Change Scale (PGIC) | Patient Global Impression of Improvement measures the response of a condition to an intervention. Patients rate their impression of change on a Likert scale ranging from 1-7 with 1 being No change/condition has gotten worse to 7 being a great deal better and a considerable improvement that has made all the difference. This scale was administered at post-treatment and follow-up only. | 2 months (after treatment is complete), 5 months | 
| Quantitative Sensory Testing (Optional) - Threshold Average | Psychophysical testing methods replicated existing protocols used at VUMC and include the following elements: 1) an evaluation of temporal summation (as a biomarker for central sensitization), 2) thermal pain threshold and tolerance. Thermal measures involved four pain threshold trials, followed by four pain tolerance trials, with the probe applied to slightly different target sites for each trial to avoid local sensitization. Means for the four threshold and tolerance trials are separately derived, and threshold is reported here. Scores range from 0 = No Pain or Warmth to 100 = Worst Possible Pain, with higher scores indicating a higher pain threshold. | baseline | 
| Quantitative Sensory Testing (Optional) - Tolerance Average | Psychophysical testing methods replicated existing protocols used at VUMC and include the following elements: 1) an evaluation of temporal summation (as a biomarker for central sensitization), 2) thermal pain threshold and tolerance. Thermal measures involved four pain threshold trials, followed by four pain tolerance trials, with the probe applied to slightly different target sites for each trial to avoid local sensitization. Means for the four threshold and tolerance trials are separately derived, and tolerance is reported here. Scores range from 0 = No Pain or Warmth to 100 = Worst Possible Pain, with higher scores indicating a higher pain tolerance. | baseline | 
| Quantitative Sensory Testing - Temporal Summation (Slope) | Psychophysical testing methods will replicate existing protocols used at VUMC and include the following elements: 1) an evaluation of temporal summation (as a biomarker for central sensitization), 2) thermal pain threshold and tolerance. Regarding temporal summation: in each sequence, immediately after each heat pulse, subjects provide a verbal numeric pain intensity rating on a 0-100 scale (0 = No Pain or Warmth and 100 = Worst Possible Pain). The standardized slope of the line fitted to the series of 10 pulses at each temperature indexes temporal summation and serves as a quantitative marker of central sensitization. These slopes reflected the relationship between pain and pulse, representing average pain increase for each unit increase in pulse. | Baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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interstitial cystitis, bladder pain syndrome, clinical trial, psychosocial intervention, pelvic pain, therapy, urological chronic pelvic pain syndrome, chronic prostatitis, self-management, cognitive behavioral therapy