Optimizing Psychosocial Treatment of Interstitial Cystitis/Bladder Pain Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Change in the Genitourinary Pain Index (GUPI) 2 Months
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age or older
- •Diagnosis of IC/BPS as given by providers or indicated by assessments
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Psychosocial Treatment (Behavioral)
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.
干预措施: Attention Control (Behavioral)
结局指标
主要结局
Change in the Genitourinary Pain Index (GUPI) 2 Months
时间窗: baseline to 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.
Change in the Genitourinary Pain Index (GUPI) 5 Months
时间窗: baseline to 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.
次要结局
- The Widespread Pain Index (Derived From CHOIR Bodymap)(baseline, 2 months (after treatment is complete), 5 months)
- Change in Anxiety Symptoms Measured by the Generalized Anxiety Disorder (GAD-7) Questionnaire(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)(2 months (after treatment is complete), 5 months)
- Change in Depressive Symptoms Measured by the Patient Health Questionnaire (PHQ-8)(baseline, 2 months (after treatment is complete), 5 months)
- Quantitative Sensory Testing (Optional) - Threshold Average(baseline)
- Fibromyalgia Symptom Scale (FSS)(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(baseline, 2 months (after treatment is complete), 5 months)
- Quantitative Sensory Testing (Optional) - Tolerance Average(baseline)
- Quantitative Sensory Testing - Temporal Summation (Slope)(Baseline)
研究者
Lindsey Mckernan
Associate Professor
Vanderbilt University Medical Center