Interstitial Cystitis and Bladder Pain SyndromeL2TNCT07797010
Learning to THRIVE (L2T) Program Pilot
A study testing Learning to THRIVE (L2T) Program in people with Interstitial Cystitis and Bladder Pain Syndrome, run by University of Indianapolis at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Interstitial Cystitis and Bladder Pain Syndrome
- What is being tested?
- Learning to THRIVE (L2T) Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Aug 2023to 24 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Indianapolis
Indianapolis, Indiana, 46227
About this study
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.
Read the 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.
- Being tested
- Learning to THRIVE (L2T) Program
- Keywords
- online behavioral intervention, chronic pelvic pain; chronic primary pain; self-management; pain education; peer support
- Medical subject headings
- Cystitis, Interstitial, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Learning to THRIVE (L2T) ProgramBehavioural
Also called Learning to THRIVE, L2T
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.
| Study group | Role | What they receive |
|---|---|---|
| Learning to THRIVE Program | Experimental | Participants received the six-week Learning to THRIVE online educational self-management program. Receives: Behavioral: Learning to THRIVE (L2T) Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: From enrollment through 6 weeks after the 6-week intervention, approximately 12 weeks
Secondary outcomes (6)
Interstitial Cystitis Symptom Index (ICSI) Score
O'Leary-Sant ICSI total score, range 0-20; higher scores indicate greater urinary/pain symptom severity.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: Baseline, immediately after the 6-week intervention, and 6 weeks post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2026
- Study start29 Aug 2023
- Primary completion24 Dec 2023
- Study completion24 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Interstitial Cystitis and Bladder Pain SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-group feasibility pilot with repeated assessments at baseline, immediately after the six-week intervention, and six weeks after the intervention.
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Indianapolis
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elizabeth Moore, University of Indianapolis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07797010
- Sponsor's protocol ID
- 01889
- Acronym
- L2T
- Status last verified
- Aug 2026
- First submitted
- 27 Aug 2026
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Learning to THRIVE (L2T) Program Pilot
- ClinicalTrials.gov ID
- NCT07797010
- Acronym / sponsor ID
- L2T / 01889
- Keywords
- online behavioral intervention, chronic pelvic pain; chronic primary pain; self-management; pain education; peer support
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of IndianapolisUniversity, hospital or other
- Study start
- 29 Aug 2023 (actual)
- Primary completion
- 24 Dec 2023 (actual)
- Study completion
- 24 Dec 2023 (actual)
- First posted
- 1 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-group feasibility pilot with repeated assessments at baseline, immediately after the six-week intervention, and six weeks after the intervention.
| Arm | Type | Receives |
|---|---|---|
| Learning to THRIVE Program | Experimental | Behavioral: Learning to THRIVE (L2T) ProgramParticipants received the six-week Learning to THRIVE online educational self-management program. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Learning to THRIVE (L2T) ProgramAlso: Learning to THRIVE, L2TA 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. | Behavioural | Learning to THRIVE Program |
Primary outcome
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.
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).
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.
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.
6 secondary outcomes
Interstitial Cystitis Symptom Index (ICSI) Score
Time frame: Baseline, immediately after the 6-week intervention, and 6 weeks post-intervention
Interstitial Cystitis Problem Index (ICPI) Score
Time frame: Baseline, immediately after the 6-week intervention, and 6 weeks post-intervention
Pain Intensity Severity Category
Time frame: Baseline, immediately after the 6-week intervention, and 6 weeks post-intervention
Pain Interference Severity Category
Time frame: Baseline, immediately after the 6-week intervention, and 6 weeks post-intervention
Pain-Related Distress Severity Category
Time frame: Baseline, immediately after the 6-week intervention, and 6 weeks post-intervention
Self-Efficacy for Managing Chronic Disease (SEMCD) Score
Time frame: Baseline, immediately after the 6-week intervention, and 6 weeks post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Learning to THRIVE (L2T) Program in people with Interstitial Cystitis and Bladder Pain Syndrome, run by University of Indianapolis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Enrolled During the Recruitment Period (time frame: During the recruitment period, approximately 3 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.