Trial Outcomes & Findings for Optimizing Psychosocial Treatment of Interstitial Cystitis/Bladder Pain Syndrome (NCT NCT04275297)

NCT ID: NCT04275297

Last Updated: 2023-08-08

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 78 participants
• Primary outcome timeframe: baseline to 2 months
• Results posted on: 2023-08-08

Participant Flow

Participant milestones

Measure	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.
Overall Study STARTED	52	26
Overall Study Completed Optional In-person Assessment Including Quantitative Sensory Testing	29	11
Overall Study COMPLETED	51	25
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Measure	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.
Overall Study Lost to Follow-up	1	1

Baseline Characteristics

One participant was enrolled in the study and randomized to attention control, but did not complete any baseline assessments. This participant's age was accessible from the consent form so was included in that baseline measurement, but no other baseline data was gathered from this participant.

Baseline characteristics by cohort

Measure	Psychosocial Treatment n=52 Participants 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 n=26 Participants 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.	Total n=78 Participants Total of all reporting groups
Age, Continuous	45.1 years STANDARD_DEVIATION 16.5 • n=52 Participants	43.1 years STANDARD_DEVIATION 16 • n=26 Participants	44.4 years STANDARD_DEVIATION 16.3 • n=78 Participants
Sex: Female, Male Female	48 Participants n=52 Participants • One participant was enrolled in the study and randomized to attention control, but did not complete any baseline assessments. This participant's age was accessible from the consent form so was included in that baseline measurement, but no other baseline data was gathered from this participant.	23 Participants n=25 Participants • One participant was enrolled in the study and randomized to attention control, but did not complete any baseline assessments. This participant's age was accessible from the consent form so was included in that baseline measurement, but no other baseline data was gathered from this participant.	71 Participants n=77 Participants • One participant was enrolled in the study and randomized to attention control, but did not complete any baseline assessments. This participant's age was accessible from the consent form so was included in that baseline measurement, but no other baseline data was gathered from this participant.
Sex: Female, Male Male	4 Participants n=52 Participants • One participant was enrolled in the study and randomized to attention control, but did not complete any baseline assessments. This participant's age was accessible from the consent form so was included in that baseline measurement, but no other baseline data was gathered from this participant.	2 Participants n=25 Participants • One participant was enrolled in the study and randomized to attention control, but did not complete any baseline assessments. This participant's age was accessible from the consent form so was included in that baseline measurement, but no other baseline data was gathered from this participant.	6 Participants n=77 Participants • One participant was enrolled in the study and randomized to attention control, but did not complete any baseline assessments. This participant's age was accessible from the consent form so was included in that baseline measurement, but no other baseline data was gathered from this participant.
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=52 Participants • One participant was enrolled in the study and randomized to attention control, but did not complete any baseline assessments. This participant's age was accessible from the consent form so was included in that baseline measurement, but no other baseline data was gathered from this participant.	0 Participants n=25 Participants • One participant was enrolled in the study and randomized to attention control, but did not complete any baseline assessments. This participant's age was accessible from the consent form so was included in that baseline measurement, but no other baseline data was gathered from this participant.	1 Participants n=77 Participants • One participant was enrolled in the study and randomized to attention control, but did not complete any baseline assessments. This participant's age was accessible from the consent form so was included in that baseline measurement, but no other baseline data was gathered from this participant.
Ethnicity (NIH/OMB) Not Hispanic or Latino	51 Participants n=52 Participants • One participant was enrolled in the study and randomized to attention control, but did not complete any baseline assessments. This participant's age was accessible from the consent form so was included in that baseline measurement, but no other baseline data was gathered from this participant.	25 Participants n=25 Participants • One participant was enrolled in the study and randomized to attention control, but did not complete any baseline assessments. This participant's age was accessible from the consent form so was included in that baseline measurement, but no other baseline data was gathered from this participant.	76 Participants n=77 Participants • One participant was enrolled in the study and randomized to attention control, but did not complete any baseline assessments. This participant's age was accessible from the consent form so was included in that baseline measurement, but no other baseline data was gathered from this participant.
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=52 Participants • One participant was enrolled in the study and randomized to attention control, but did not complete any baseline assessments. This participant's age was accessible from the consent form so was included in that baseline measurement, but no other baseline data was gathered from this participant.	0 Participants n=25 Participants • One participant was enrolled in the study and randomized to attention control, but did not complete any baseline assessments. This participant's age was accessible from the consent form so was included in that baseline measurement, but no other baseline data was gathered from this participant.	0 Participants n=77 Participants • One participant was enrolled in the study and randomized to attention control, but did not complete any baseline assessments. This participant's age was accessible from the consent form so was included in that baseline measurement, but no other baseline data was gathered from this participant.
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=52 Participants • One participant was enrolled in the study and randomized to attention control, but did not complete any baseline assessments. This participant's age was accessible from the consent form so was included in that baseline measurement, but no other baseline data was gathered from this participant.	0 Participants n=25 Participants • One participant was enrolled in the study and randomized to attention control, but did not complete any baseline assessments. This participant's age was accessible from the consent form so was included in that baseline measurement, but no other baseline data was gathered from this participant.	0 Participants n=77 Participants • One participant was enrolled in the study and randomized to attention control, but did not complete any baseline assessments. This participant's age was accessible from the consent form so was included in that baseline measurement, but no other baseline data was gathered from this participant.
Race (NIH/OMB) Asian	1 Participants n=52 Participants • One participant was enrolled in the study and randomized to attention control, but did not complete any baseline assessments. This participant's age was accessible from the consent form so was included in that baseline measurement, but no other baseline data was gathered from this participant.	1 Participants n=25 Participants • One participant was enrolled in the study and randomized to attention control, but did not complete any baseline assessments. This participant's age was accessible from the consent form so was included in that baseline measurement, but no other baseline data was gathered from this participant.	2 Participants n=77 Participants • One participant was enrolled in the study and randomized to attention control, but did not complete any baseline assessments. This participant's age was accessible from the consent form so was included in that baseline measurement, but no other baseline data was gathered from this participant.
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=52 Participants • One participant was enrolled in the study and randomized to attention control, but did not complete any baseline assessments. This participant's age was accessible from the consent form so was included in that baseline measurement, but no other baseline data was gathered from this participant.	1 Participants n=25 Participants • One participant was enrolled in the study and randomized to attention control, but did not complete any baseline assessments. This participant's age was accessible from the consent form so was included in that baseline measurement, but no other baseline data was gathered from this participant.	1 Participants n=77 Participants • One participant was enrolled in the study and randomized to attention control, but did not complete any baseline assessments. This participant's age was accessible from the consent form so was included in that baseline measurement, but no other baseline data was gathered from this participant.
Race (NIH/OMB) Black or African American	2 Participants n=52 Participants • One participant was enrolled in the study and randomized to attention control, but did not complete any baseline assessments. This participant's age was accessible from the consent form so was included in that baseline measurement, but no other baseline data was gathered from this participant.	1 Participants n=25 Participants • One participant was enrolled in the study and randomized to attention control, but did not complete any baseline assessments. This participant's age was accessible from the consent form so was included in that baseline measurement, but no other baseline data was gathered from this participant.	3 Participants n=77 Participants • One participant was enrolled in the study and randomized to attention control, but did not complete any baseline assessments. This participant's age was accessible from the consent form so was included in that baseline measurement, but no other baseline data was gathered from this participant.
Race (NIH/OMB) White	49 Participants n=52 Participants • One participant was enrolled in the study and randomized to attention control, but did not complete any baseline assessments. This participant's age was accessible from the consent form so was included in that baseline measurement, but no other baseline data was gathered from this participant.	21 Participants n=25 Participants • One participant was enrolled in the study and randomized to attention control, but did not complete any baseline assessments. This participant's age was accessible from the consent form so was included in that baseline measurement, but no other baseline data was gathered from this participant.	70 Participants n=77 Participants • One participant was enrolled in the study and randomized to attention control, but did not complete any baseline assessments. This participant's age was accessible from the consent form so was included in that baseline measurement, but no other baseline data was gathered from this participant.
Race (NIH/OMB) More than one race	0 Participants n=52 Participants • One participant was enrolled in the study and randomized to attention control, but did not complete any baseline assessments. This participant's age was accessible from the consent form so was included in that baseline measurement, but no other baseline data was gathered from this participant.	0 Participants n=25 Participants • One participant was enrolled in the study and randomized to attention control, but did not complete any baseline assessments. This participant's age was accessible from the consent form so was included in that baseline measurement, but no other baseline data was gathered from this participant.	0 Participants n=77 Participants • One participant was enrolled in the study and randomized to attention control, but did not complete any baseline assessments. This participant's age was accessible from the consent form so was included in that baseline measurement, but no other baseline data was gathered from this participant.
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=52 Participants • One participant was enrolled in the study and randomized to attention control, but did not complete any baseline assessments. This participant's age was accessible from the consent form so was included in that baseline measurement, but no other baseline data was gathered from this participant.	1 Participants n=25 Participants • One participant was enrolled in the study and randomized to attention control, but did not complete any baseline assessments. This participant's age was accessible from the consent form so was included in that baseline measurement, but no other baseline data was gathered from this participant.	1 Participants n=77 Participants • One participant was enrolled in the study and randomized to attention control, but did not complete any baseline assessments. This participant's age was accessible from the consent form so was included in that baseline measurement, but no other baseline data was gathered from this participant.
Region of Enrollment United States	52 participants n=52 Participants	26 participants n=26 Participants	78 participants n=78 Participants

PRIMARY outcome

Timeframe: baseline to 2 months

Population: We analyzed a total of N=77 individuals from baseline to post-treatment. Below is the change in the total genitourinary pain index (GUPI) score between both timepoints.

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.

Outcome measures

Measure	Psychosocial Treatment n=52 Participants 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 n=25 Participants 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.
Change in the Genitourinary Pain Index (GUPI) 2 Months	6.6 score on a scale Standard Deviation 6.9	4.8 score on a scale Standard Deviation 9.0

PRIMARY outcome

Timeframe: baseline to 5 months

Population: We analyzed a total of N=77 individuals from baseline to follow-up. Below is the change in the total genitourinary pain index (GUPI) score between both timepoints.

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.

Outcome measures

Measure	Psychosocial Treatment n=52 Participants 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 n=25 Participants 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.
Change in the Genitourinary Pain Index (GUPI) 5 Months	8.1 score on a scale Standard Deviation 9.9	6.6 score on a scale Standard Deviation 7.3

SECONDARY outcome

Timeframe: baseline, 2 months (after treatment is complete), 5 months

Population: We analyzed a total of N=77 individuals from baseline to post-treatment. Below is the change in the total PHQ score between both timepoints both from pre-post treatment and then from pre-treatment to follow-up.

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.

Outcome measures

Measure	Psychosocial Treatment n=52 Participants 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 n=25 Participants 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.
Change in Depressive Symptoms Measured by the Patient Health Questionnaire (PHQ-8) Baseline to post-treatment (2 months)	0.9 score on a scale Standard Deviation 4.6	1.0 score on a scale Standard Deviation 4.3
Change in Depressive Symptoms Measured by the Patient Health Questionnaire (PHQ-8) Baseline to follow-up (5 months)	0.8 score on a scale Standard Deviation 5.2	0.0 score on a scale Standard Deviation 3.4

SECONDARY outcome

Timeframe: baseline, 2 months (after treatment is complete), 5 months

Population: We analyzed a total of N=77 individuals from baseline to follow-up. Below is the change in the total WPI score between both timepoints both from pre-post treatment and then from pre-treatment to follow-up. Change in total FSS score is not included here, but is reported separately.

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.

Outcome measures

Measure	Psychosocial Treatment n=52 Participants 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 n=25 Participants 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.
The Widespread Pain Index (Derived From CHOIR Bodymap) Baseline to post treatment (2 months)	0.6 score on a scale Standard Deviation 2.9	0.1 score on a scale Standard Deviation 2.7
The Widespread Pain Index (Derived From CHOIR Bodymap) Baseline to follow up (5 months)	0.9 score on a scale Standard Deviation 3.5	0.4 score on a scale Standard Deviation 3.6

SECONDARY outcome

Timeframe: baseline, 2 months (after treatment is complete), 5 months

Population: We analyzed a total of N=77 individuals from baseline to post-treatment. Below is the change in the total FSS score between both timepoints both from pre-post treatment and then from pre-treatment to follow-up. Change in WPI is reported separately above.

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.

Outcome measures

Measure	Psychosocial Treatment n=52 Participants 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 n=25 Participants 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.
Fibromyalgia Symptom Scale (FSS) Baseline to post treatment (2 months)	0.4 score on a scale Standard Deviation 1.9	0.7 score on a scale Standard Deviation 1.4
Fibromyalgia Symptom Scale (FSS) Baseline to follow-up (5 months)	0.8 score on a scale Standard Deviation 1.8	0.2 score on a scale Standard Deviation 1.3

SECONDARY outcome

Timeframe: baseline, 2 months (after treatment is complete), 5 months

Population: We analyzed a total of N=77 individuals from baseline to post-treatment. Below is the change in the total PCL-5 score between both timepoints both from pre-post treatment and then from pre-treatment to follow-up.

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.

Outcome measures

Measure	Psychosocial Treatment n=52 Participants 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 n=25 Participants 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.
Change in Posttraumatic Stress Symptoms Measured by PTSD Checklist for DSM-5 (PCL-5) With Criterion A Baseline to post-treatment (2 months)	-2.8 score on a scale Standard Deviation 9.9	-1.3 score on a scale Standard Deviation 11.6
Change in Posttraumatic Stress Symptoms Measured by PTSD Checklist for DSM-5 (PCL-5) With Criterion A Baseline to follow-up (5 months)	0.1 score on a scale Standard Deviation 13.8	-3.5 score on a scale Standard Deviation 12.1

SECONDARY outcome

Timeframe: baseline, 2 months (after treatment is complete), 5 months

Population: We analyzed a total of N=77 individuals from baseline to post-treatment. Below is the change in the total GAD-7 score between both timepoints both from pre-post treatment and then from pre-treatment to follow-up.

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).

Outcome measures

Measure	Psychosocial Treatment n=52 Participants 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 n=25 Participants 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.
Change in Anxiety Symptoms Measured by the Generalized Anxiety Disorder (GAD-7) Questionnaire Baseline to post-treatment (2 months)	0.5 score on a scale Standard Deviation 4	0.6 score on a scale Standard Deviation 4
Change in Anxiety Symptoms Measured by the Generalized Anxiety Disorder (GAD-7) Questionnaire Baseline to follow-up (5 months)	0.1 score on a scale Standard Deviation 4.5	-0.1 score on a scale Standard Deviation 3.5

SECONDARY outcome

Timeframe: 2 months (after treatment is complete), 5 months

Population: We analyzed a total of N=77 individuals from baseline to post-treatment. Below is the change in the total PGIC score between both timepoints both from pre-post treatment and then from pre-treatment to follow-up.

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.

Outcome measures

Measure	Psychosocial Treatment n=52 Participants 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 n=25 Participants 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.
Difference in Response to Treatment/Perceived Improvement and Quality of Life Between Groups as Measured by the Patient Global Impression of Change Scale (PGIC) Baseline to post-treatment (2 months)	4.7 score on a scale Standard Deviation 1.6	2.8 score on a scale Standard Deviation 1.6
Difference in Response to Treatment/Perceived Improvement and Quality of Life Between Groups as Measured by the Patient Global Impression of Change Scale (PGIC) Baseline to follow-up (5 months)	4.4 score on a scale Standard Deviation 1.5	3.1 score on a scale Standard Deviation 1.6

SECONDARY outcome

Timeframe: baseline

Population: We analyzed a total of 40 participants who completed Quantitative Sensory Testing at baseline.

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.

Outcome measures

Measure	Psychosocial Treatment n=29 Participants 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 n=11 Participants 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.
Quantitative Sensory Testing (Optional) - Threshold Average	44.65 score on a scale Standard Deviation 3.41	40.76 score on a scale Standard Deviation 2.96

SECONDARY outcome

Timeframe: baseline

Population: We analyzed a total of 40 participants who completed Quantitative Sensory Testing.

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.

Outcome measures

Measure	Psychosocial Treatment n=29 Participants 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 n=11 Participants 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.
Quantitative Sensory Testing (Optional) - Tolerance Average	47.89 units on a scale Standard Deviation 1.09	47.29 units on a scale Standard Deviation 1.79

SECONDARY outcome

Timeframe: Baseline

Population: A total of 40 participants completed (optional) quantitative sensory testing at baseline allowing us to calculate temporal summation.

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.

Outcome measures

Measure	Psychosocial Treatment n=29 Participants 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 n=11 Participants 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.
Quantitative Sensory Testing - Temporal Summation (Slope)	-.23 units on a scale/pulse Standard Deviation 2.18	-.21 units on a scale/pulse Standard Deviation 2.70

Adverse Events

Psychosocial Treatment

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Attention Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Psychosocial Treatment n=52 participants at risk 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 n=26 participants at risk 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.
Musculoskeletal and connective tissue disorders Temporary pain increase	1.9% 1/52 • Number of events 1 • From date of randomization up to 97 days post-treatment, an average of 5.5 months. Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time of randomization through participant completion.	0.00% 0/26 • From date of randomization up to 97 days post-treatment, an average of 5.5 months. Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time of randomization through participant completion.

Additional Information

A. Gracie Kelly, MS, Research Assistant

Osher Center for Integrative Health

Phone: 6153431554

Email: gracie.kelly@vumc.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place