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Completed

NCT Number: NCT07797010

Learning to THRIVE (L2T) Program Pilot

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.

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Key information

Conditions

Interstitial Cystitis and Bladder Pain Syndrome Chronic Pain Cystitis Cystitis, Interstitial Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Bladder Diseases Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Indianapolis

Indianapolis, Indiana, 46227, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Learning to THRIVE (L2T) Program

Behavioral

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

Primary outcomes

  1. Number of Participants Enrolled During the Recruitment Period

    Time frame: 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.

  2. Participant-Reported Time Spent Reviewing Weekly Asynchronous Lessons

    Time frame: 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).

  3. Number of Weekly Live Virtual Sessions Attended

    Time frame: 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.

  4. Number of Enrolled Participants Retained Through the Final Follow-Up Assessment

    Time frame: 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 outcomes

  1. Interstitial Cystitis Symptom Index (ICSI) Score

    Time frame: 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.

  2. Interstitial Cystitis Problem Index (ICPI) Score

    Time frame: 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.

  3. Pain Intensity Severity Category

    Time frame: 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).

  4. Pain Interference Severity Category

    Time frame: 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).

  5. Pain-Related Distress Severity Category

    Time frame: 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).

  6. Self-Efficacy for Managing Chronic Disease (SEMCD) Score

    Time frame: 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.

Other outcomes

  1. Participant Perceptions of Program Acceptability and Experience

    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

    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.

Sponsors and collaborators

Lead sponsor

University of Indianapolis

Other

Registry information

Acronym: L2T

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Sep 1, 2026
Registry last updated
Sep 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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