Purpose

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.

Conditions

Eligibility

Eligible Ages
Between 18 Years and 100 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
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
Masking
Single (Investigator)
Masking Description
Randomization will occur following the initial assessment visit once an individual has enrolled in the trail. Randomization will occur by statistical personnel and the study investigator will be blinded to this process. Following randomization, an individual will be called by a study clinical provider to either establish appointments in person or via telephone. Participants will be aware of their assigned group following randomization, as these groups are inherently different and cannot be masked.

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Psychosocial Treatment
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
    The psychosocial intervention will consist of 8 weekly 50-minute individual visits with the assigned therapist.
Placebo Comparator
Attention Control
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
    The Attention Control will reflect a similar visit pattern and duration as intervention sessions.

Recruiting Locations

Vanderbilt University Medical Center
Nashville, Tennessee 37212

More Details

Status
Recruiting
Sponsor
Vanderbilt University Medical Center

Study Contact

Rachel Smith, BA
615-875-7214
rachel.m.smith.1@vumc.org

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.