Interstitial Cystitis and Bladder Pain Syndrome
Conditions
Keywords
online behavioral intervention, chronic pelvic pain; chronic primary pain; self-management; pain education; peer support
Brief summary
This pilot study evaluated the feasibility and potential effects of Learning to THRIVE (L2T), a six-week online educational self-management program for adults who self-identified as women or female and had interstitial cystitis/bladder pain syndrome (IC/BPS). L2T combined self-paced online educational materials with a weekly live virtual group session. The primary feasibility objectives were recruitment, engagement, and retention. Exploratory outcomes included IC/BPS symptom and problem severity, pain intensity, pain-related interference and distress, and self-efficacy for chronic disease management. Qualitative data were collected to understand participants' experiences with the program.
Detailed description
L2T used a flipped-classroom format over six weeks. Participants reviewed asynchronous e-learning materials each week and then attended a 60-90 minute live virtual group session facilitated by the research team to discuss and apply the lesson content. The program was informed by the THRIVE model, chronic pain science, adult learning, and instructional design principles. Quantitative assessments were conducted at baseline, immediately after the intervention, and 6 weeks after the intervention. Qualitative data were collected through open-ended survey questions, weekly lesson feedback, recordings of synchronous sessions, and post-intervention semi-structured interviews. This ClinicalTrials.gov record was entered retrospectively after study completion and was reconstructed from contemporaneous IRB-approved study materials.
Interventions
BEHAVIORALLearning to THRIVE (L2T) Program
A six-week online self-management program using a flipped-classroom format. Each week, participants reviewed asynchronous e-learning materials and attended one 60-90 minute live virtual group meeting facilitated by the research team. Content addressed goal setting and safe-group expectations; chronic pain and factors influencing pain; self-care, habits, and self-efficacy; relationships, communication, and sexual health; informed healthcare decision-making and evaluation of health claims; and reflection with long-term action planning.
Sponsors
University of Indianapolis
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Single-group feasibility pilot with repeated assessments at baseline, immediately after the six-week intervention, and six weeks after the intervention.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Self-identifies as a woman or female * Age 18 years or older * Self-reported healthcare provider-confirmed diagnosis of interstitial cystitis/bladder pain syndrome (IC/BPS) * Pelvic pain, pressure, or discomfort for at least 6 months, of at least moderate severity (greater than 3 on a 0-10 numerical rating scale), causing weekly life interference and limiting life or work-related activities, general activity level, and/or enjoyment of life during the prior 3 months * Reliable access to a computer and Internet connection
Exclusion criteria
* Unable to speak/read English * Neurological condition (for example, multiple sclerosis, Parkinson disease, paraplegia) or other condition affecting the bladder * History or presence of cystitis caused by tuberculosis, radiation, or chemotherapy * Diagnosed and treated for a pelvic-related malignancy (colon, bladder, ovarian, endometrial, uterine, cervical, vaginal, or rectal cancer) * Physical or psychological comorbidity that would adversely affect ability to participate * Currently pregnant * Gross cognitive impairment, deafness, blindness, or severe vision/hearing problems that could not be accommodated * Current psychotherapy directed specifically toward relief of urological symptoms
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Enrolled During the Recruitment Period | During the recruitment period, approximately 3 weeks | Number of participants who provided informed consent and enrolled during the planned recruitment period. The protocol planned to recruit 16 participants. |
| Participant-Reported Time Spent Reviewing Weekly Asynchronous Lessons | Weekly during the 6-week intervention | Approximate time spent reviewing each weekly lesson, self-reported on the weekly lesson feedback form. Summarize using the metric used in the analysis (for example, median hours per week). |
| Number of Weekly Live Virtual Sessions Attended | During the 6-week intervention | Facilitator-recorded attendance across the six weekly synchronous virtual meetings. Each participant could attend 0 to 6 sessions; a percentage of sessions attended may also be derived. |
| Number of Enrolled Participants Retained Through the Final Follow-Up Assessment | From enrollment through 6 weeks after the 6-week intervention, approximately 12 weeks | Number and percentage of enrolled participants who remained in the study through the six-week post-intervention data-collection point. The protocol planned to recruit 16 participants and hoped to retain at least 12 through the intervention and post-intervention data-collection period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Interstitial Cystitis Symptom Index (ICSI) Score | Baseline, immediately after the 6-week intervention, and 6 weeks post-intervention | O'Leary-Sant ICSI total score, range 0-20; higher scores indicate greater urinary/pain symptom severity. |
| Interstitial Cystitis Problem Index (ICPI) Score | Baseline, immediately after the 6-week intervention, and 6 weeks post-intervention | O'Leary-Sant ICPI total score, range 0-16; higher scores indicate greater symptom-related problems. |
| Pain Intensity Severity Category | Baseline, immediately after the 6-week intervention, and 6 weeks post-intervention | Pain intensity during the prior week assessed on an 11-point numerical rating scale from 0 to 10 and categorized according to the protocol as none (0), mild (1-3), moderate (4-6), or severe (7-10). |
| Pain Interference Severity Category | Baseline, immediately after the 6-week intervention, and 6 weeks post-intervention | Pain-related interference with activities during the prior week assessed on an 11-point numerical rating scale from 0 to 10 and categorized as none (0), mild (1-3), moderate (4-6), or severe (7-10). |
| Pain-Related Distress Severity Category | Baseline, immediately after the 6-week intervention, and 6 weeks post-intervention | Pain-related distress during the prior week assessed on an 11-point numerical rating scale from 0 to 10 and categorized as none (0), mild (1-3), moderate (4-6), or severe (7-10). |
| Self-Efficacy for Managing Chronic Disease (SEMCD) Score | Baseline, immediately after the 6-week intervention, and 6 weeks post-intervention | Six-item SEMCD scale scored from 1 to 10, with higher scores indicating greater confidence in managing chronic disease. The protocol included SEMCD as a quantitative outcome at all three assessments. |
Countries
United States
Outcome results
None listed