An interventional study of Learning to THRIVE (L2T) Program in Interstitial Cystitis and Bladder Pain Syndrome, sponsored by University of Indianapolis. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-01.
Sponsored by University of Indianapolis · Not applicable, Interventional, and Supportive care
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.
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.
Exclusion Criteria:
Participants received the six-week Learning to THRIVE online educational self-management program.
Behavioral: Learning 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.
Also known as: Learning to THRIVE, L2T
Number of Participants Enrolled During the Recruitment Period
Number of participants who provided informed consent and enrolled during the planned recruitment period. The protocol planned to recruit 16 participants.
Time frame: During the recruitment period, approximately 3 weeks
Participant-Reported Time Spent Reviewing Weekly Asynchronous Lessons
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).
Time frame: Weekly during the 6-week intervention
Number of Weekly Live Virtual Sessions Attended
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.
Time frame: During the 6-week intervention
Number of Enrolled Participants Retained Through the Final Follow-Up Assessment
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.
Time frame: From enrollment through 6 weeks after the 6-week intervention, approximately 12 weeks
Interstitial Cystitis Symptom Index (ICSI) Score
O'Leary-Sant ICSI total score, range 0-20; higher scores indicate greater urinary/pain symptom severity.
Time frame: Baseline, immediately after the 6-week intervention, and 6 weeks post-intervention
Interstitial Cystitis Problem Index (ICPI) Score
O'Leary-Sant ICPI total score, range 0-16; higher scores indicate greater symptom-related problems.
Time frame: Baseline, immediately after the 6-week intervention, and 6 weeks post-intervention
Pain Intensity Severity Category
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).
Time frame: Baseline, immediately after the 6-week intervention, and 6 weeks post-intervention
Pain Interference Severity Category
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).
Time frame: Baseline, immediately after the 6-week intervention, and 6 weeks post-intervention
Pain-Related Distress Severity Category
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).
Time frame: Baseline, immediately after the 6-week intervention, and 6 weeks post-intervention
Self-Efficacy for Managing Chronic Disease (SEMCD) Score
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.
Time frame: Baseline, immediately after the 6-week intervention, and 6 weeks post-intervention
Participant Perceptions of Program Acceptability and Experience
Qualitative data were collected through open-ended questions on the study surveys, weekly lesson feedback, recorded live group discussions, and semi-structured post-intervention interviews. Weekly feedback addressed key takeaways, useful content, areas needing greater clarity, and additional comments. Interviews explored expectations, program structure, content usefulness, facilitator/peer interaction, safety and comfort, application of learning, and whether participants would recommend the program. Data were prospectively planned for thematic analysis.
Time frame: Weekly during the 6-week intervention and within 1 month after intervention completion; open-ended survey data also collected at baseline, immediately post-intervention, and 6 weeks post-intervention
Plan to share: Undecided — The informed consent permits possible future research use or sharing of de-identified study data, but a specific individual participant data sharing plan, access mechanism, and timetable have not yet been established.
No publications or documents are linked to this record.
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University of Indianapolis