Optimizing Psychosocial Treatment of Interstitial Cystitis/Bladder Pain Syndrome
NCT ID: NCT04275297
Last Updated: 2023-08-08
Study Results
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View full resultsBasic Information
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COMPLETED
NA
78 participants
INTERVENTIONAL
2020-07-13
2023-06-16
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
Psychosocial Treatment
The psychosocial intervention will consist of 8 weekly 50-minute individual visits with the assigned therapist.
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.
Attention Control
The Attention Control will reflect a similar visit pattern and duration as intervention sessions.
Interventions
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Psychosocial Treatment
The psychosocial intervention will consist of 8 weekly 50-minute individual visits with the assigned therapist.
Attention Control
The Attention Control will reflect a similar visit pattern and duration as intervention sessions.
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of IC/BPS as given by providers or indicated by assessments
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Vanderbilt University Medical Center
OTHER
Responsible Party
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Lindsey Mckernan
Associate Professor
Principal Investigators
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Lindsey McKernan, PhD MPH
Role: PRINCIPAL_INVESTIGATOR
Vanderbilt University Medical Center
Locations
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Vanderbilt University Medical Center
Nashville, Tennessee, United States
Countries
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References
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Hanno PM, Burks DA, Clemens JQ, Dmochowski RR, Erickson D, Fitzgerald MP, Forrest JB, Gordon B, Gray M, Mayer RD, Newman D, Nyberg L Jr, Payne CK, Wesselmann U, Faraday MM; Interstitial Cystitis Guidelines Panel of the American Urological Association Education and Research, Inc. AUA guideline for the diagnosis and treatment of interstitial cystitis/bladder pain syndrome. J Urol. 2011 Jun;185(6):2162-70. doi: 10.1016/j.juro.2011.03.064. Epub 2011 Apr 16.
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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193461
Identifier Type: -
Identifier Source: org_study_id
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