Irritable Bowel Syndrome
Conditions
Keywords
IBS - Irritable Bowel Syndrome, IBS, Irritable Bowel
Brief summary
A Randomized, Double-Blind, Comparator-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Two Self-administered behavioral treatments for Adult Subjects with Symptomatic Irritable Bowel Syndrome (IBS).
Detailed description
EASITx is a pivotal study comparing two self-administered behavioral treatments for irritable bowel syndrome (IBS). The active treatment in EASITx is classified as Software as a Medical Device (SaaMD).
Interventions
DEVICEArm 1 - Active behavioral Treatment Arm (Regulora; Gut-Directed Hypnotherapy Software as a Medical Device - SaMD)
The active treatment consists of 7 unique video/audio recordings administered via a mobile application every other week for 12 weeks (SaMD). Since subjects in both the active and comparator treatment arms receive a behavioral treatment, the subjects are blinded to active treatment.
DEVICEArm 2 - Active Comparator behavioral treatment arm (MR-1; Muscle Relaxation, Software as a Medical Device - SaMD)
The comparator treatment consists of an identical treatment platform, scheduling platform, and reminder platform as the Active Treatment Arm, but in place of Gut-Directed Hypnotherapy there is a comparator relaxation treatment administered on an identical schedule: 7 unique video/audio recordings administered via a mobile application every other week for 12 weeks.
Sponsors
metaMe Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Intervention model description
A Randomized, Double-Blind, Comparator-Controlled, Parallel-Group Study
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Provision of signed and dated informed consent form * Stated willingness to comply with all study procedures and availability for the duration of the study * Male or female, aged 18-70 * Confirmation of the IBS and IBS subtype diagnosis by a study site physician using Rome IV diagnostic criteria * Possess an iPhone Operating System (iOS) Apple or Android smartphone or iOS tablet (iPad) released in 2015 or later * Agreement to input information about their abdominal pain and bowel movements on a daily basis into Curebase software * Agreement to have their anonymized data stored in the cloud for up to 2 years after the conclusion of the study, and to have the data used for research purposes. * Agreement to maintain stable dosage of IBS medications during the course of treatment and not to add new IBS medication or stop current IBS medications unless directed to do so by the participants treating physician. Changes in treatment will be captured using a concomitant medication assessment. * Average Worst Daily Pain Severity of \>3 on a 11-point numeric rating scale (NRS) over the full 28-day pre-treatment symptom tracking period * Consistent submission of Pain Severity scores via the Curebase app (data submitted on 80% or more of days in the symptom tracking window)
Exclusion criteria
* Evidence of current structural intestinal abnormalities that better explain the participant's IBS symptoms (e.g., celiac disease, inflammatory bowel disease - Crohn's Disease and ulcerative colitis, prior abdominal surgeries such as weight loss surgery or bowel resection) * Medication use, other illnesses or conditions that can explain their gastrointestinal symptoms e.g.,regular narcotic use or dependency, Over The Counter (OTC) stimulant laxative dependence (i.e, progressively larger doses of Senna or Bisacodyl containing compounds are needed to produce a bowel movement), history of radiation to the abdomen. * Diagnosed and/or treated for a malignancy within the past 5 years (other than localized basal or squamous cell carcinomas of the skin) * Current psychotherapy, hypnotherapy, or cognitive behavioral therapy (CBT) for IBS * Inability to commit to completing all treatment sessions * Have an unstable extraintestinal condition whose immediate or foreseeable treatment needs would realistically interfere with study demands, e.g., ability to participate in online treatment sessions or follow daily diary. * Active psychiatric disorder (e.g., post-traumatic stress disorder, depression associated with high risk of suicidal behavior, psychotic or delusional disorders, dissociative disorders, or gross cognitive impairment) * Subjects that report a current gastrointestinal infection or an infection within the 4 weeks prior to the evaluation that would otherwise obscure IBS symptoms. In cases of gastrointestinal infection baseline evaluation will be delayed a minimum of 4 weeks until after complete recovery. * Current or recent use of a gut-targeted antibiotic such as Neomycin or Rifaximin during the 12 weeks prior to baseline assessment. In the case of treatment with rifaximin or neomycin, eligibility will be suspended for 12 weeks from the initial date of use. * Any condition that an investigator feels may interfere with the conduct of the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Abdominal Pain Intensity Responder | Baseline score (average of daily score for weeks -4 through -1) was compared to 4-weeks post-treatment (average daily score for weeks 13 through 16) | The primary endpoint of this study is abdominal pain intensity. The Instrument is a 0-10 numeric rating scale (NRS, 0= no pain, 10= worst pain). The subject is asked daily to record their worst abdominal pain over the past 24-hours. An Abdominal Pain Intensity Responder is defined as a subject whose daily abdominal pain intensity averaged over the 4 weeks post-treatment (weeks 13 through 16) is at least 30% reduced compared to the daily abdominal pain intensity averaged over the 4 weeks pre-treatment (weeks -4 through -1). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Abdominal Pain Frequency | Change from baseline (weeks -4 to -1 before treatment) to 4-week post treatment period (Weeks 13-16) | Mean change in reported abdominal pain frequency. The abdominal pain frequency is based on the frequency of abdominal pain measured using a 0-10 numeric rating scale (NRS, 0= no pain, 10= worst pain). The subject is asked daily to record their worst abdominal pain over the past 24-hours. Average abdominal pain frequency is defined as the average number of days per week during the 4-week post-treatment assessment period in which the subjects recorded a 1 or greater on the daily pain measurement. Only days during which an assessment is recorded will be included in the calculation of average abdominal pain frequency. Days where severity was \>0 were considered a day with pain and were recorded as positive. Days with a score of 0 were days without pain. Mean represents the mean number of days per week in each time period with abdominal pain. A lower score is a better outcome. |
| Number of Participants With >=30% Improvement in Normal Bowel Movements (Scored as 3, 4, or 5 on the Bristol Stool Form Scale) | Baseline score (average of daily score for weeks -4 through -1) was compared to 4-weeks post-treatment (average daily score for weeks 13 through 16) | Number of Participants with a ≥ 30% improvement in the proportion of Bristol Stool Form Scale (BSFS) scores that fell within Group 2 (normal stools) compared with baseline (Weeks -4 through -1). The result represents the number of participants with ≥ 30% improvement in the percentage of normal stools The BSFS is a visual aid that allows patients to classify their bowel movements into seven groups ranging from a score of 1 (separate hard lumps) to 7 (watery, no solid pieces). The BSFS scores will be grouped as 1,2 (Group 1), 3,4,5 (Group 2) and 6,7 (Group 3). The mid-range bowel movements 3,4 and 5 (Group 2) define normal stools. |
| Daily Stool Frequency | Baseline score (average of daily score for weeks -4 through -1) was compared to 4-weeks post-treatment (average daily score for weeks 13 through 16) | Mean change in reported daily stool frequency Analyses of change in daily stool frequency will only include participants with IBS-C and IBS-D. IBS-C and IBS-D subtypes will be analyzed independently. |
| Abdominal Pain Intensity | Baseline score (average of daily score for weeks -4 through -1) was compared to 4-weeks post-treatment (average daily score for weeks 13 through 16) | The Instrument is a 0-10 numeric rating scale (NRS, 0= no pain, 10= worst pain). The subject is asked daily to record their worst abdominal pain over the past 24-hours. Mean change in reported abdominal pain intensity. |
| Percent Overall Work Impairment Due to IBS Based on the Work Productivity and Activity Impairment (WPAI) Questionnaire | Baseline (Week -4) to 4-weeks post-treatment (Week 16) | Productivity and absenteeism will be evaluated using the patient reported Work Productivity and Activity Impairment (WPAI) General Health score. The WPAI (Reilly 1993) is a 6-question survey of presenteeism (impairment at work / reduced on-the-job effectiveness) and absenteeism (work time missed). The WPAI-GH consists of six questions: 1 = currently employed; 2 = hours missed due to health problems; 3 = hours missed other reasons; 4 = hours actually worked; 5 = degree health affected productivity while working (using a 0 to 10 Visual Analogue Scale (VAS)); 6 = degree health affected productivity in regular unpaid activities (VAS). Outcomes are expressed as impairment percentages (0-100%) with higher numbers indicating greater impairment and less productivity (worse outcomes). |
| Percent Overall Activity Impairment Due to IBS Based on the Work Productivity and Activity Impairment (WPAI) Questionnaire | 4-weeks post-treatment (Week 16) | Productivity and absenteeism will be evaluated using the patient reported Work Productivity and Activity Impairment (WPAI) General Health score. The WPAI (Reilly 1993) is a 6-question survey of presenteeism (impairment at work / reduced on-the-job effectiveness) and absenteeism (work time missed). The WPAI-GH consists of six questions: 1 = currently employed; 2 = hours missed due to health problems; 3 = hours missed other reasons; 4 = hours actually worked; 5 = degree health affected productivity while working (using a 0 to 10 Visual Analogue Scale (VAS)); 6 = degree health affected productivity in regular unpaid activities (VAS). Overall activity impairment is based on responses to Question 6. Outcomes are expressed as impairment percentages (0-100%) with higher numbers indicating greater impairment and less productivity (worse outcomes). |
| Health-related Quality of Life Using the IBS Quality of Life (QOL) Instrument | Baseline (Week -4) to 4-weeks post-treatment (Week 16) | The IBS QOL is a 34 item IBS-specific, validated instrument. The 34 items are summed for a total score and then transformed to 0-100 scale with higher scores indicating better IBS specific quality of life. IBS QOL scores will be compared pre- and post-treatment and the mean difference compared by treatment. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Regulora; Gut-Directed Hypnotherapy Software as a Medical Device - SaMD Arm 1 is an active behavioral treatment for IBS (Regulora; Gut-Directed Hypnotherapy Software as a Medical Device - SaMD).
Arm 1 - Active behavioral Treatment Arm (Regulora; Gut-Directed Hypnotherapy Software as a Medical Device - SaMD): The active treatment consists of 7 unique video/audio recordings administered via a mobile application every other week for 12 weeks (SaMD). Since subjects in both the active and comparator treatment arms receive a behavioral treatment, the subjects are blinded to active treatment. | 181 |
| MR-1; Muscle Relaxation, Software as a Medical Device - SaMD Arm 2 is a behavioral treatment (MR-1; Muscle Relaxation, Software as a Medical Device - SaMD)
Arm 2 - Active Comparator behavioral treatment arm (MR-1; Muscle Relaxation, Software as a Medical Device - SaMD): The comparator treatment consists of an identical treatment platform, scheduling platform, and reminder platform as the Active Treatment Arm, but in place of Gut-Directed Hypnotherapy there is a comparator relaxation treatment administered on an identical schedule: 7 unique video/audio recordings administered via a mobile application every other week for 12 weeks. | 181 |
| Total | 362 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Never started treatment | 1 | 1 |
| Overall Study | Protocol Violation | 0 | 1 |
| Overall Study | Withdrawal by Subject | 5 | 4 |
Baseline characteristics
| Characteristic | Regulora; Gut-Directed Hypnotherapy Software as a Medical Device - SaMD | Total | MR-1; Muscle Relaxation, Software as a Medical Device - SaMD |
|---|---|---|---|
| Age, Continuous | 42.5 years STANDARD_DEVIATION 12.1 | 42.5 years STANDARD_DEVIATION 12.1 | 42.6 years STANDARD_DEVIATION 12.2 |
| Baseline abdominal pain frequency | 6.8 days per week STANDARD_DEVIATION 0.47 | 6.8 days per week STANDARD_DEVIATION 0.44 | 6.8 days per week STANDARD_DEVIATION 0.42 |
| Baseline abdominal pain intensity | 5.5 units on a scale STANDARD_DEVIATION 1.75 | 5.4 units on a scale STANDARD_DEVIATION 1.68 | 5.4 units on a scale STANDARD_DEVIATION 1.6 |
| Baseline IBS-Quality of Life score | 54.7 units on a scale STANDARD_DEVIATION 20.89 | 52.9 units on a scale STANDARD_DEVIATION 21.08 | 51.1 units on a scale STANDARD_DEVIATION 21.19 |
| IBS with constipation (IBS-C) | 60 Participants | 122 Participants | 62 Participants |
| IBS with diarrhea (IBS-D) | 62 Participants | 122 Participants | 60 Participants |
| IBS with mixed bowel habits (IBS-M) | 59 Participants | 117 Participants | 58 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) Asian | 14 Participants | 30 Participants | 16 Participants |
| Race (NIH/OMB) Black or African American | 52 Participants | 111 Participants | 59 Participants |
| Race (NIH/OMB) More than one race | 9 Participants | 16 Participants | 7 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 3 Participants | 3 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) White | 101 Participants | 196 Participants | 95 Participants |
| Region of Enrollment United States | 181 participants | 362 participants | 181 participants |
| Sex: Female, Male Female | 144 Participants | 289 Participants | 145 Participants |
| Sex: Female, Male Male | 37 Participants | 73 Participants | 36 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 188 | 0 / 190 |
| other Total, other adverse events | 6 / 188 | 2 / 190 |
| serious Total, serious adverse events | 1 / 188 | 0 / 190 |
Outcome results
Primary
Abdominal Pain Intensity Responder
The primary endpoint of this study is abdominal pain intensity. The Instrument is a 0-10 numeric rating scale (NRS, 0= no pain, 10= worst pain). The subject is asked daily to record their worst abdominal pain over the past 24-hours. An Abdominal Pain Intensity Responder is defined as a subject whose daily abdominal pain intensity averaged over the 4 weeks post-treatment (weeks 13 through 16) is at least 30% reduced compared to the daily abdominal pain intensity averaged over the 4 weeks pre-treatment (weeks -4 through -1).
Time frame: Baseline score (average of daily score for weeks -4 through -1) was compared to 4-weeks post-treatment (average daily score for weeks 13 through 16)
Population: 16 participants in the safety analysis population were excluded from the efficacy analysis population; 8 were excluded for being under age 22 (4 in each treatment group), and 7 participants (4 in the MR group and 3 in the GDH group) did not meet eligibility criteria or experienced technical issues with the Curebase software that prevented study execution. Additionally, 2 participants (1 in each group) were excluded because they did not begin a treatment session.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Regulora; Gut-Directed Hypnotherapy Software as a Medical Device - SaMD | Abdominal Pain Intensity Responder | 55 Participants |
| MR-1; Muscle Relaxation, Software as a Medical Device - SaMD | Abdominal Pain Intensity Responder | 49 Participants |
Comparison: P value from Cochran-Mantel-Haenszel testing of H0: OR=1; H1: OR≠1 adjusting for IBS subtype and genderp-value: 0.535295% CI: [0.73, 1.84]Cochran-Mantel-Haenszel
Comparison: The final 4 weeks of the on-treatment period (weeks 9-12) was a pre-specified period for analysis of the primary endpoint measure of abdominal pain due to IBS. An abdominal pain intensity responder was defined as a participant whose daily abdominal pain intensity averaged over the last 4 weeks of phase s (weeks 9 through 12) was at least 30% reduced compared with the daily abdominal pain intensity averaged over the 4 weeks of phase 1.p-value: 0.023295% CI: [1.08, 2.87]Cochran-Mantel-Haenszel
Comparison: Abdominal pain scores were averaged each week on treatment (1-12) and compared with the average baseline abdominal pain score. Participants that recorded a \> 30% decrease in abdominal pain in at least half the weeks on treatment were considered responders.~This analysis was specified in FDA Guidance for Industry, Irritable Bowel Syndrome - Clinical Evaluation of Drugs for Treatment, May 2012. Both the analysis period and the responder threshold (30%) are specified by the FDA Guidance.p-value: 0.025495% CI: [1.07, 2.89]Cochran-Mantel-Haenszel
Secondary
Abdominal Pain Frequency
Mean change in reported abdominal pain frequency. The abdominal pain frequency is based on the frequency of abdominal pain measured using a 0-10 numeric rating scale (NRS, 0= no pain, 10= worst pain). The subject is asked daily to record their worst abdominal pain over the past 24-hours. Average abdominal pain frequency is defined as the average number of days per week during the 4-week post-treatment assessment period in which the subjects recorded a 1 or greater on the daily pain measurement. Only days during which an assessment is recorded will be included in the calculation of average abdominal pain frequency. Days where severity was \>0 were considered a day with pain and were recorded as positive. Days with a score of 0 were days without pain. Mean represents the mean number of days per week in each time period with abdominal pain. A lower score is a better outcome.
Time frame: Change from baseline (weeks -4 to -1 before treatment) to 4-week post treatment period (Weeks 13-16)
Population: The analysis population includes all participants with both baseline (weeks -4 to -1 before treatment) and 4-week post treatment period (Weeks 13-16) daily pain scores.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Regulora; Gut-Directed Hypnotherapy Software as a Medical Device - SaMD | Abdominal Pain Frequency | -0.366 days/week with abdominal pain | Standard Deviation 1.1272 |
| MR-1; Muscle Relaxation, Software as a Medical Device - SaMD | Abdominal Pain Frequency | -0.437 days/week with abdominal pain | Standard Deviation 1.2437 |
Comparison: Average abdominal pain frequency at Week 13-16 will be statistically compared between GDH and comparator using an ANOVA model adjusted for gender and IBS subtype. The daily pain frequency measurement was derived from the daily pain intensity measurement. Days where severity was \>0 were considered a day with pain and were recorded as positive. Days with a score of 0 were days without pain. Mean represents the mean number of days in each time period with abdominal pain.p-value: 0.756495% CI: [-0.236, 0.325]ANOVA
Secondary
Abdominal Pain Intensity
The Instrument is a 0-10 numeric rating scale (NRS, 0= no pain, 10= worst pain). The subject is asked daily to record their worst abdominal pain over the past 24-hours. Mean change in reported abdominal pain intensity.
Time frame: Baseline score (average of daily score for weeks -4 through -1) was compared to 4-weeks post-treatment (average daily score for weeks 13 through 16)
Population: The analysis population includes all participants with both baseline (weeks -4 to -1 before treatment) and 4-week post treatment period (Weeks 13-16) daily pain scores
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Regulora; Gut-Directed Hypnotherapy Software as a Medical Device - SaMD | Abdominal Pain Intensity | -0.995 units on a scale | Standard Deviation 1.66 |
| MR-1; Muscle Relaxation, Software as a Medical Device - SaMD | Abdominal Pain Intensity | -1.031 units on a scale | Standard Deviation 1.68 |
Comparison: The least square (LS) mean difference between the GDH and MR groups using an analysis of variance (ANOVA) modelp-value: 0.811595% CI: [-0.434, 0.554]ANOVA
Secondary
Daily Stool Frequency
Mean change in reported daily stool frequency Analyses of change in daily stool frequency will only include participants with IBS-C and IBS-D. IBS-C and IBS-D subtypes will be analyzed independently.
Time frame: Baseline score (average of daily score for weeks -4 through -1) was compared to 4-weeks post-treatment (average daily score for weeks 13 through 16)
Population: A total of 115 participants treated with GDH are included in the analysis population: 59 patients had IBS-C and 56 patients had IBS-D. A total of 116 patients treated with MR are included: 59 patients had IBS-C and 57 patients had IBS-D. These numbers are smaller than the total size of the IBS-C and IBS-D populations because not all patients completed the daily diaries for weeks 13 through 16.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Regulora; Gut-Directed Hypnotherapy Software as a Medical Device - SaMD | Daily Stool Frequency | IBS-C subgroup of participants | -0.074 number of bowel movements per day | Standard Deviation 0.8964 |
| Regulora; Gut-Directed Hypnotherapy Software as a Medical Device - SaMD | Daily Stool Frequency | IBS-D subgroup of participants | -0.325 number of bowel movements per day | Standard Deviation 0.6915 |
| MR-1; Muscle Relaxation, Software as a Medical Device - SaMD | Daily Stool Frequency | IBS-C subgroup of participants | 0.151 number of bowel movements per day | Standard Deviation 0.4531 |
| MR-1; Muscle Relaxation, Software as a Medical Device - SaMD | Daily Stool Frequency | IBS-D subgroup of participants | -0.455 number of bowel movements per day | Standard Deviation 1.2904 |
Comparison: The analysis is based on the mixed model repeated measures (MMRM) analysis of variance model for IBS-C participants:~parameter = treatment + timepoint + treatment\*timepoint + gender + subject error + random Means are the mean daily number of bowel movements for a 24-hour period.p-value: 0.679395% CI: [-0.301, 0.46]Mixed Models Analysis
Comparison: The analysis is based on the mixed model repeated measures (MMRM) analysis of variance model for IBS-D participants:~parameter = treatment + timepoint + treatment\*timepoint + gender + subject error + random Means are the mean daily number of bowel movements for a 24-hour period.p-value: 0.946895% CI: [-4.904, 5.249]Mixed Models Analysis
Secondary
Health-related Quality of Life Using the IBS Quality of Life (QOL) Instrument
The IBS QOL is a 34 item IBS-specific, validated instrument. The 34 items are summed for a total score and then transformed to 0-100 scale with higher scores indicating better IBS specific quality of life. IBS QOL scores will be compared pre- and post-treatment and the mean difference compared by treatment.
Time frame: Baseline (Week -4) to 4-weeks post-treatment (Week 16)
Population: Participants that completed the IBS-QoL at Week 16
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Regulora; Gut-Directed Hypnotherapy Software as a Medical Device - SaMD | Health-related Quality of Life Using the IBS Quality of Life (QOL) Instrument | 8.075 score on a scale | Standard Deviation 19.2567 |
| MR-1; Muscle Relaxation, Software as a Medical Device - SaMD | Health-related Quality of Life Using the IBS Quality of Life (QOL) Instrument | 5.816 score on a scale | Standard Deviation 23.015 |
Comparison: The analysis is based on the mixed model repeated measures (MMRM) analysis of variance model:~parameter = treatment + timepoint + treatment\*timepoint + gender + subject error + random The unstructured covariance matrix was used to model the within-participant correlation. The model-based least square (LS) means and LS mean differences (GDH minus comparator) and associated 95% CIs for each week and overall were estimated.p-value: 0.501595% CI: [-6.282, 3.077]Mixed Models Analysis
Secondary
Number of Participants With >=30% Improvement in Normal Bowel Movements (Scored as 3, 4, or 5 on the Bristol Stool Form Scale)
Number of Participants with a ≥ 30% improvement in the proportion of Bristol Stool Form Scale (BSFS) scores that fell within Group 2 (normal stools) compared with baseline (Weeks -4 through -1). The result represents the number of participants with ≥ 30% improvement in the percentage of normal stools The BSFS is a visual aid that allows patients to classify their bowel movements into seven groups ranging from a score of 1 (separate hard lumps) to 7 (watery, no solid pieces). The BSFS scores will be grouped as 1,2 (Group 1), 3,4,5 (Group 2) and 6,7 (Group 3). The mid-range bowel movements 3,4 and 5 (Group 2) define normal stools.
Time frame: Baseline score (average of daily score for weeks -4 through -1) was compared to 4-weeks post-treatment (average daily score for weeks 13 through 16)
Population: 16 participants in the safety analysis population were excluded from the efficacy analysis population; 8 were excluded for being under age 22 (4 in each treatment group), and 7 participants (4 in the MR group and 3 in the GDH group) did not meet eligibility criteria or experienced technical issues with the Curebase software that prevented study execution. Additionally, 2 participants (1 in each group) were excluded because they did not begin a treatment session.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Regulora; Gut-Directed Hypnotherapy Software as a Medical Device - SaMD | Number of Participants With >=30% Improvement in Normal Bowel Movements (Scored as 3, 4, or 5 on the Bristol Stool Form Scale) | 77 Participants |
| MR-1; Muscle Relaxation, Software as a Medical Device - SaMD | Number of Participants With >=30% Improvement in Normal Bowel Movements (Scored as 3, 4, or 5 on the Bristol Stool Form Scale) | 72 Participants |
Comparison: A Stool Consistency Responder is defined as a \>=30% improvement in the proportion of Bristol Stool Form Scale (BSFS) scores that fall within Group 2 (normal stools)p-value: 0.475395% CI: [0.76, 1.81]Cochran-Mantel-Haenszel
Secondary
Percent Overall Activity Impairment Due to IBS Based on the Work Productivity and Activity Impairment (WPAI) Questionnaire
Productivity and absenteeism will be evaluated using the patient reported Work Productivity and Activity Impairment (WPAI) General Health score. The WPAI (Reilly 1993) is a 6-question survey of presenteeism (impairment at work / reduced on-the-job effectiveness) and absenteeism (work time missed). The WPAI-GH consists of six questions: 1 = currently employed; 2 = hours missed due to health problems; 3 = hours missed other reasons; 4 = hours actually worked; 5 = degree health affected productivity while working (using a 0 to 10 Visual Analogue Scale (VAS)); 6 = degree health affected productivity in regular unpaid activities (VAS). Overall activity impairment is based on responses to Question 6. Outcomes are expressed as impairment percentages (0-100%) with higher numbers indicating greater impairment and less productivity (worse outcomes).
Time frame: 4-weeks post-treatment (Week 16)
Population: Participants who completed the WPAI at Week 16
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Regulora; Gut-Directed Hypnotherapy Software as a Medical Device - SaMD | Percent Overall Activity Impairment Due to IBS Based on the Work Productivity and Activity Impairment (WPAI) Questionnaire | 42.9 percentage of impairment | Standard Deviation 25.92 |
| MR-1; Muscle Relaxation, Software as a Medical Device - SaMD | Percent Overall Activity Impairment Due to IBS Based on the Work Productivity and Activity Impairment (WPAI) Questionnaire | 40.2 percentage of impairment | Standard Deviation 28.06 |
Comparison: The analysis is based on the mixed model repeated measures (MMRM) analysis of variance model: parameter = treatment + timepoint + treatment\*timepoint + gender + subject error + randomp-value: 0.367695% CI: [-2.793, 7.537]Mixed Models Analysis
Secondary
Percent Overall Work Impairment Due to IBS Based on the Work Productivity and Activity Impairment (WPAI) Questionnaire
Productivity and absenteeism will be evaluated using the patient reported Work Productivity and Activity Impairment (WPAI) General Health score. The WPAI (Reilly 1993) is a 6-question survey of presenteeism (impairment at work / reduced on-the-job effectiveness) and absenteeism (work time missed). The WPAI-GH consists of six questions: 1 = currently employed; 2 = hours missed due to health problems; 3 = hours missed other reasons; 4 = hours actually worked; 5 = degree health affected productivity while working (using a 0 to 10 Visual Analogue Scale (VAS)); 6 = degree health affected productivity in regular unpaid activities (VAS). Outcomes are expressed as impairment percentages (0-100%) with higher numbers indicating greater impairment and less productivity (worse outcomes).
Time frame: Baseline (Week -4) to 4-weeks post-treatment (Week 16)
Population: Participants who completed the WPAI at Week 16 and who were currently employed (working for pay).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Regulora; Gut-Directed Hypnotherapy Software as a Medical Device - SaMD | Percent Overall Work Impairment Due to IBS Based on the Work Productivity and Activity Impairment (WPAI) Questionnaire | -18.1 percentage of impairment | Standard Deviation 27.59 |
| MR-1; Muscle Relaxation, Software as a Medical Device - SaMD | Percent Overall Work Impairment Due to IBS Based on the Work Productivity and Activity Impairment (WPAI) Questionnaire | -14.4 percentage of impairment | Standard Deviation 25.22 |
Comparison: Percent Overall Work Impairment Due to IBS defined as the percent time missed by not showing up for work, plus the percent time missed while working, and calculated as: Q2/(Q2+Q4)+\[(1-(Q2/(Q2+Q4))x(Q5/10)\].p-value: 0.211795% CI: [-2.619, 11.79]Mixed Models Analysis