Optimizing Psychosocial Treatment of Interstitial Cystitis/Bladder Pain Syndrome

Vanderbilt University Medical Center

Status: Completed

Conditions: Cystitis, Chronic Interstitial; Chronic Prostatitis With Chronic Pelvic Pain Syndrome; Chronic Interstitial Cystitis; Chronic Prostatitis; Cystitis, Interstitial; Interstitial Cystitis (Chronic) With Hematuria; Interstitial Cystitis; Interstitial Cystitis, Chronic; Painful Bladder Syndrome; Bladder Pain Syndrome; Interstitial Cystitis (Chronic) Without Hematuria

Treatments: Behavioral: Psychosocial Treatment; Behavioral: Attention Control

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04275297

193461

K23DK118118 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 78 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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78 participants in 2 patient groups, including a placebo group

Psychosocial Treatment

Experimental group

Description:

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.

Treatment:

Behavioral: Psychosocial Treatment

Attention Control

Placebo Comparator group

Description:

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.

Treatment:

Behavioral: Attention Control