Learning to THRIVE (L2T) Program Pilot (L2T)

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.

Study Overview

• Status: Completed
• Conditions: Interstitial Cystitis and Bladder Pain Syndrome
• Intervention / Treatment: Behavioral: Learning to THRIVE (L2T) 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.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46227
      • University of Indianapolis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Learning to THRIVE Program; 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.; Other Names: Learning to THRIVE; L2T

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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).	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.	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.	From enrollment through 6 weeks after the 6-week intervention, approximately 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Interstitial Cystitis Symptom Index (ICSI) Score	O'Leary-Sant ICSI total score, range 0-20; higher scores indicate greater urinary/pain symptom severity.	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.	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).	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).	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).	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.	Baseline, immediately after the 6-week intervention, and 6 weeks post-intervention

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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

Collaborators and Investigators

• Sponsor: University of Indianapolis

Study record dates

Study Major Dates

• Study Start (Actual): August 29, 2023
• Primary Completion (Actual): December 24, 2023
• Study Completion (Actual): December 24, 2023

Study Registration Dates

• First Submitted: August 27, 2026
• First Submitted That Met QC Criteria: August 27, 2026
• First Posted (Actual): September 1, 2026

Study Record Updates

• Last Update Posted (Actual): September 1, 2026
• Last Update Submitted That Met QC Criteria: August 27, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: online behavioral intervention; chronic pelvic pain; chronic primary pain; self-management; pain education; peer support
• Additional Relevant MeSH Terms: Urogenital Diseases; Pain; Neurologic Manifestations; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urinary Bladder Diseases; Cystitis; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Chronic Pain; Cystitis, Interstitial
• Other Study ID Numbers: 01889

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No