Learning to THRIVE (L2T) Program Pilot

University of Indianapolis15 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

Interstitial Cystitis Symptom Index (ICSI) Score

O'Leary-Sant ICSI total score, range 0-20; higher scores indicate greater urinary/pain symptom severity.