An interventional study of Psychosocial Treatment and Attention Control in Chronic Interstitial Cystitis, Bladder Pain Syndrome and Cystitis, Interstitial, sponsored by Vanderbilt University Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-08-08.
Sponsored by Vanderbilt University Medical Center · Not applicable, Interventional, and Treatment
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.
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.
236 studies on the registry are indexed under Cystitis, Interstitial; 35 are open to participants now.
This study's enrollment of 78 is above the median of 51 across 158 interventional studies indexed under Cystitis, Interstitial.
Browse Cystitis, Interstitial studies →Vanderbilt University Medical Center is the lead sponsor of 833 studies on the registry; 155 are open to participants now.
Of its 125 completed or terminated interventional studies of FDA-regulated products, 92 (74%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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 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 psychosocial intervention will consist of 8 weekly 50-minute individual visits with the assigned therapist.
The Attention Control will reflect a similar visit pattern and duration as intervention sessions.
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.
Time frame: 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.
Time frame: baseline to 5 months
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline
| Milestone | Psychosocial Treatment | Attention Control |
|---|---|---|
| Started | 52 | 26 |
| Completed optional in-person assessment including quantitative sensory testing | 29 | 11 |
| Completed | 51 | 25 |
| Not completed | 1 | 1 |
| Withdrew: Lost to follow-up | 1 | 1 |
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.
| score on a scale | Psychosocial Treatment | Attention Control |
|---|---|---|
| Change in the Genitourinary Pain Index (GUPI) 2 Months | 6.6 ± 6.9 | 4.8 ± 9.0 |
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.
| score on a scale | Psychosocial Treatment | Attention Control |
|---|---|---|
| Change in the Genitourinary Pain Index (GUPI) 5 Months | 8.1 ± 9.9 | 6.6 ± 7.3 |
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.
| score on a scale | Psychosocial Treatment | Attention Control |
|---|---|---|
| Baseline to post-treatment (2 months) | 0.9 ± 4.6 | 1.0 ± 4.3 |
| Baseline to follow-up (5 months) | 0.8 ± 5.2 | 0.0 ± 3.4 |
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.
| score on a scale | Psychosocial Treatment | Attention Control |
|---|---|---|
| Baseline to post treatment (2 months) | 0.6 ± 2.9 | 0.1 ± 2.7 |
| Baseline to follow up (5 months) | 0.9 ± 3.5 | 0.4 ± 3.6 |
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.
| score on a scale | Psychosocial Treatment | Attention Control |
|---|---|---|
| Baseline to post treatment (2 months) | 0.4 ± 1.9 | 0.7 ± 1.4 |
| Baseline to follow-up (5 months) | 0.8 ± 1.8 | 0.2 ± 1.3 |
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.
| score on a scale | Psychosocial Treatment | Attention Control |
|---|---|---|
| Baseline to post-treatment (2 months) | -2.8 ± 9.9 | -1.3 ± 11.6 |
| Baseline to follow-up (5 months) | 0.1 ± 13.8 | -3.5 ± 12.1 |
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).
| score on a scale | Psychosocial Treatment | Attention Control |
|---|---|---|
| Baseline to post-treatment (2 months) | 0.5 ± 4 | 0.6 ± 4 |
| Baseline to follow-up (5 months) | 0.1 ± 4.5 | -0.1 ± 3.5 |
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.
| score on a scale | Psychosocial Treatment | Attention Control |
|---|---|---|
| Baseline to post-treatment (2 months) | 4.7 ± 1.6 | 2.8 ± 1.6 |
| Baseline to follow-up (5 months) | 4.4 ± 1.5 | 3.1 ± 1.6 |
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.
| score on a scale | Psychosocial Treatment | Attention Control |
|---|---|---|
| Quantitative Sensory Testing (Optional) - Threshold Average | 44.65 ± 3.41 | 40.76 ± 2.96 |
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.
| units on a scale | Psychosocial Treatment | Attention Control |
|---|---|---|
| Quantitative Sensory Testing (Optional) - Tolerance Average | 47.89 ± 1.09 | 47.29 ± 1.79 |
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.
| units on a scale/pulse | Psychosocial Treatment | Attention Control |
|---|---|---|
| Quantitative Sensory Testing - Temporal Summation (Slope) | -.23 ± 2.18 | -.21 ± 2.70 |
Collected over From date of randomization up to 97 days post-treatment, an average of 5.5 months.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Psychosocial Treatment | 0/52 (0%) | 0/52 (0%) | 1/52 (1.9%) |
| Attention Control | 0/26 (0%) | 0/26 (0%) | 0/26 (0%) |
| Event | Psychosocial Treatment | Attention Control |
|---|---|---|
| Temporary pain increaseMusculoskeletal and connective tissue disorders | 1/52 | 0/26 |
One participant enrolled in the study and was randomized to attention control, but did not complete any baseline assessments. This participant's age was accessible from the consent form, and was therefore included in that baseline measurement, but no other data from this participant was gathered.
| Age, Continuous(years) | Psychosocial Treatment | Attention Control | Total |
|---|---|---|---|
| Mean | 45.1 ± 16.5 | 43.1 ± 16 | 44.4 ± 16.3 |
| Sex: Female, Male(Participants) | Psychosocial Treatment | Attention Control | Total |
|---|---|---|---|
| Female | 48 | 23 | 71 |
| Male | 4 | 2 | 6 |
| Ethnicity (NIH/OMB)(Participants) | Psychosocial Treatment | Attention Control | Total |
|---|---|---|---|
| Hispanic or Latino | 1 | 0 | 1 |
| Not Hispanic or Latino | 51 | 25 | 76 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Psychosocial Treatment | Attention Control | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 1 | 1 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 1 | 1 |
| Black or African American | 2 | 1 | 3 |
| White | 49 | 21 | 70 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 1 | 1 |
| Region of Enrollment(participants) | Psychosocial Treatment | Attention Control | Total |
|---|---|---|---|
| United States | 52 | 26 | 78 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — This study is occurring via a career development award mechanism through the NIDDK. The PI will establish an IPD sharing plan following consultation with study team mentors at a bi-annual mentorship team meeting in April. The information will be updated in the system accordingly.
Ran from Jul 2020 to primary completion in Jun 2022, 23 months.
Results were first posted in Aug 2023, 1 year 1 month after primary completion.
Of 35 non-industry interventional studies with no phase under Cystitis, Interstitial, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 34. This study's 23 months is close to that.
Counting every sponsor, half of 39 studies reached it within 23 months; a quarter within 16 and three quarters within 38.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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