Trial Outcomes & Findings for Efficacy and Safety of IBS Digital Behavioral Treatment (NCT NCT04133519)

Last Updated: 2022-05-04

Results Overview

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).

Recruitment status

COMPLETED

Study phase

Target enrollment

378 participants

Primary outcome timeframe

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)

Results posted on

2022-05-04

Participant Flow

Participant milestones

Participant milestones
Measure	Regulora; Gut-Directed Hypnotherapy Software as a Medical Device - SaMD Arm 1 is an active behavioral treatment for Irritable Bowel Syndrome (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.	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.
Overall Study STARTED	188	190
Overall Study COMPLETED	182	184
Overall Study NOT COMPLETED	6	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Regulora; Gut-Directed Hypnotherapy Software as a Medical Device - SaMD Arm 1 is an active behavioral treatment for Irritable Bowel Syndrome (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.	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.
Overall Study Withdrawal by Subject	5	4
Overall Study Protocol Violation	0	1
Overall Study Never started treatment	1	1

Baseline Characteristics

Efficacy and Safety of IBS Digital Behavioral Treatment

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Regulora; Gut-Directed Hypnotherapy Software as a Medical Device - SaMD n=181 Participants 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.	MR-1; Muscle Relaxation, Software as a Medical Device - SaMD n=181 Participants 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.	Total n=362 Participants Total of all reporting groups
Age, Continuous	42.5 years STANDARD_DEVIATION 12.1 • n=39 Participants	42.6 years STANDARD_DEVIATION 12.2 • n=41 Participants	42.5 years STANDARD_DEVIATION 12.1 • n=35 Participants
Sex: Female, Male Female	144 Participants n=39 Participants	145 Participants n=41 Participants	289 Participants n=35 Participants
Sex: Female, Male Male	37 Participants n=39 Participants	36 Participants n=41 Participants	73 Participants n=35 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=39 Participants	3 Participants n=41 Participants	3 Participants n=35 Participants
Race (NIH/OMB) Asian	14 Participants n=39 Participants	16 Participants n=41 Participants	30 Participants n=35 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	3 Participants n=39 Participants	0 Participants n=41 Participants	3 Participants n=35 Participants
Race (NIH/OMB) Black or African American	52 Participants n=39 Participants	59 Participants n=41 Participants	111 Participants n=35 Participants
Race (NIH/OMB) White	101 Participants n=39 Participants	95 Participants n=41 Participants	196 Participants n=35 Participants
Race (NIH/OMB) More than one race	9 Participants n=39 Participants	7 Participants n=41 Participants	16 Participants n=35 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=39 Participants	1 Participants n=41 Participants	3 Participants n=35 Participants
Region of Enrollment United States	181 participants n=39 Participants	181 participants n=41 Participants	362 participants n=35 Participants
Baseline abdominal pain intensity	5.5 units on a scale STANDARD_DEVIATION 1.75 • n=39 Participants	5.4 units on a scale STANDARD_DEVIATION 1.60 • n=41 Participants	5.4 units on a scale STANDARD_DEVIATION 1.68 • n=35 Participants
Baseline abdominal pain frequency	6.8 days per week STANDARD_DEVIATION 0.47 • n=39 Participants	6.8 days per week STANDARD_DEVIATION 0.42 • n=41 Participants	6.8 days per week STANDARD_DEVIATION 0.44 • n=35 Participants
Baseline IBS-Quality of Life score	54.7 units on a scale STANDARD_DEVIATION 20.89 • n=39 Participants	51.1 units on a scale STANDARD_DEVIATION 21.19 • n=41 Participants	52.9 units on a scale STANDARD_DEVIATION 21.08 • n=35 Participants
IBS with constipation (IBS-C)	60 Participants n=39 Participants	62 Participants n=41 Participants	122 Participants n=35 Participants
IBS with diarrhea (IBS-D)	62 Participants n=39 Participants	60 Participants n=41 Participants	122 Participants n=35 Participants
IBS with mixed bowel habits (IBS-M)	59 Participants n=39 Participants	58 Participants n=41 Participants	117 Participants n=35 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Regulora; Gut-Directed Hypnotherapy Software as a Medical Device - SaMD n=181 Participants 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.	MR-1; Muscle Relaxation, Software as a Medical Device - SaMD n=181 Participants 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.
Abdominal Pain Intensity Responder	55 Participants	49 Participants

SECONDARY outcome

Timeframe: 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

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.

Outcome measures

Outcome measures
Measure	Regulora; Gut-Directed Hypnotherapy Software as a Medical Device - SaMD n=168 Participants 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.	MR-1; Muscle Relaxation, Software as a Medical Device - SaMD n=167 Participants 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.
Abdominal Pain Intensity	-0.995 units on a scale Standard Deviation 1.66	-1.031 units on a scale Standard Deviation 1.68

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Regulora; Gut-Directed Hypnotherapy Software as a Medical Device - SaMD n=171 Participants 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.	MR-1; Muscle Relaxation, Software as a Medical Device - SaMD n=174 Participants 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.
Abdominal Pain Frequency	-0.366 days/week with abdominal pain Standard Deviation 1.1272	-0.437 days/week with abdominal pain Standard Deviation 1.2437

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Regulora; Gut-Directed Hypnotherapy Software as a Medical Device - SaMD n=181 Participants 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.	MR-1; Muscle Relaxation, Software as a Medical Device - SaMD n=181 Participants 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.
Number of Participants With >=30% Improvement in Normal Bowel Movements (Scored as 3, 4, or 5 on the Bristol Stool Form Scale)	77 Participants	72 Participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Regulora; Gut-Directed Hypnotherapy Software as a Medical Device - SaMD n=115 Participants 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.	MR-1; Muscle Relaxation, Software as a Medical Device - SaMD n=116 Participants 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.
Daily Stool Frequency IBS-C subgroup of participants	-0.074 number of bowel movements per day Standard Deviation 0.8964	0.151 number of bowel movements per day Standard Deviation 0.4531
Daily Stool Frequency IBS-D subgroup of participants	-0.325 number of bowel movements per day Standard Deviation 0.6915	-0.455 number of bowel movements per day Standard Deviation 1.2904

SECONDARY outcome

Timeframe: Baseline (Week -4) to 4-weeks post-treatment (Week 16)

Population: Participants that completed the IBS-QoL at 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.

Outcome measures

Outcome measures
Measure	Regulora; Gut-Directed Hypnotherapy Software as a Medical Device - SaMD n=165 Participants 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.	MR-1; Muscle Relaxation, Software as a Medical Device - SaMD n=166 Participants 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.
Health-related Quality of Life Using the IBS Quality of Life (QOL) Instrument	8.075 score on a scale Standard Deviation 19.2567	5.816 score on a scale Standard Deviation 23.0150

SECONDARY outcome

Timeframe: 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).

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).

Outcome measures

Outcome measures
Measure	Regulora; Gut-Directed Hypnotherapy Software as a Medical Device - SaMD n=90 Participants 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.	MR-1; Muscle Relaxation, Software as a Medical Device - SaMD n=87 Participants 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.
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	-14.4 percentage of impairment Standard Deviation 25.22

SECONDARY outcome

Timeframe: 4-weeks post-treatment (Week 16)

Population: Participants who completed the WPAI at 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).

Outcome measures

Outcome measures
Measure	Regulora; Gut-Directed Hypnotherapy Software as a Medical Device - SaMD n=164 Participants 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.	MR-1; Muscle Relaxation, Software as a Medical Device - SaMD n=163 Participants 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.
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	40.2 percentage of impairment Standard Deviation 28.06

Adverse Events

Regulora; Gut-Directed Hypnotherapy Software as a Medical Device - SaMD

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

MR-1; Muscle Relaxation, Software as a Medical Device - SaMD

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Regulora; Gut-Directed Hypnotherapy Software as a Medical Device - SaMD n=188 participants at risk 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.	MR-1; Muscle Relaxation, Software as a Medical Device - SaMD n=190 participants at risk 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.
Infections and infestations COVID-19	0.53% 1/188 • Number of events 1 • 16 Weeks All adverse events (AEs) will be coded to system organ class (SOC) and preferred terms (PT). A treatment-emergent AE (TEAE) is defined as an AE that was not present prior to treatment with the investigational digital device, but appeared following treatment or was present at treatment initiation but worsened during treatment. The frequency of TEAEs will be tabulated by preferred term and system organ class. The maximum severity and frequency of TEAEs will be summarized by treatment.	0.00% 0/190 • 16 Weeks All adverse events (AEs) will be coded to system organ class (SOC) and preferred terms (PT). A treatment-emergent AE (TEAE) is defined as an AE that was not present prior to treatment with the investigational digital device, but appeared following treatment or was present at treatment initiation but worsened during treatment. The frequency of TEAEs will be tabulated by preferred term and system organ class. The maximum severity and frequency of TEAEs will be summarized by treatment.
Infections and infestations Pneumonia	0.53% 1/188 • Number of events 1 • 16 Weeks All adverse events (AEs) will be coded to system organ class (SOC) and preferred terms (PT). A treatment-emergent AE (TEAE) is defined as an AE that was not present prior to treatment with the investigational digital device, but appeared following treatment or was present at treatment initiation but worsened during treatment. The frequency of TEAEs will be tabulated by preferred term and system organ class. The maximum severity and frequency of TEAEs will be summarized by treatment.	0.00% 0/190 • 16 Weeks All adverse events (AEs) will be coded to system organ class (SOC) and preferred terms (PT). A treatment-emergent AE (TEAE) is defined as an AE that was not present prior to treatment with the investigational digital device, but appeared following treatment or was present at treatment initiation but worsened during treatment. The frequency of TEAEs will be tabulated by preferred term and system organ class. The maximum severity and frequency of TEAEs will be summarized by treatment.
Nervous system disorders Idiopathic intracranial hypertension	0.53% 1/188 • Number of events 1 • 16 Weeks All adverse events (AEs) will be coded to system organ class (SOC) and preferred terms (PT). A treatment-emergent AE (TEAE) is defined as an AE that was not present prior to treatment with the investigational digital device, but appeared following treatment or was present at treatment initiation but worsened during treatment. The frequency of TEAEs will be tabulated by preferred term and system organ class. The maximum severity and frequency of TEAEs will be summarized by treatment.	0.00% 0/190 • 16 Weeks All adverse events (AEs) will be coded to system organ class (SOC) and preferred terms (PT). A treatment-emergent AE (TEAE) is defined as an AE that was not present prior to treatment with the investigational digital device, but appeared following treatment or was present at treatment initiation but worsened during treatment. The frequency of TEAEs will be tabulated by preferred term and system organ class. The maximum severity and frequency of TEAEs will be summarized by treatment.
Nervous system disorders Arnold-Chiari malformation	0.53% 1/188 • Number of events 1 • 16 Weeks All adverse events (AEs) will be coded to system organ class (SOC) and preferred terms (PT). A treatment-emergent AE (TEAE) is defined as an AE that was not present prior to treatment with the investigational digital device, but appeared following treatment or was present at treatment initiation but worsened during treatment. The frequency of TEAEs will be tabulated by preferred term and system organ class. The maximum severity and frequency of TEAEs will be summarized by treatment.	0.00% 0/190 • 16 Weeks All adverse events (AEs) will be coded to system organ class (SOC) and preferred terms (PT). A treatment-emergent AE (TEAE) is defined as an AE that was not present prior to treatment with the investigational digital device, but appeared following treatment or was present at treatment initiation but worsened during treatment. The frequency of TEAEs will be tabulated by preferred term and system organ class. The maximum severity and frequency of TEAEs will be summarized by treatment.

Other adverse events

Other adverse events
Measure	Regulora; Gut-Directed Hypnotherapy Software as a Medical Device - SaMD n=188 participants at risk 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.	MR-1; Muscle Relaxation, Software as a Medical Device - SaMD n=190 participants at risk 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.
Gastrointestinal disorders Abdominal pain	0.53% 1/188 • Number of events 1 • 16 Weeks All adverse events (AEs) will be coded to system organ class (SOC) and preferred terms (PT). A treatment-emergent AE (TEAE) is defined as an AE that was not present prior to treatment with the investigational digital device, but appeared following treatment or was present at treatment initiation but worsened during treatment. The frequency of TEAEs will be tabulated by preferred term and system organ class. The maximum severity and frequency of TEAEs will be summarized by treatment.	0.00% 0/190 • 16 Weeks All adverse events (AEs) will be coded to system organ class (SOC) and preferred terms (PT). A treatment-emergent AE (TEAE) is defined as an AE that was not present prior to treatment with the investigational digital device, but appeared following treatment or was present at treatment initiation but worsened during treatment. The frequency of TEAEs will be tabulated by preferred term and system organ class. The maximum severity and frequency of TEAEs will be summarized by treatment.
Gastrointestinal disorders Constipation	0.53% 1/188 • Number of events 1 • 16 Weeks All adverse events (AEs) will be coded to system organ class (SOC) and preferred terms (PT). A treatment-emergent AE (TEAE) is defined as an AE that was not present prior to treatment with the investigational digital device, but appeared following treatment or was present at treatment initiation but worsened during treatment. The frequency of TEAEs will be tabulated by preferred term and system organ class. The maximum severity and frequency of TEAEs will be summarized by treatment.	0.00% 0/190 • 16 Weeks All adverse events (AEs) will be coded to system organ class (SOC) and preferred terms (PT). A treatment-emergent AE (TEAE) is defined as an AE that was not present prior to treatment with the investigational digital device, but appeared following treatment or was present at treatment initiation but worsened during treatment. The frequency of TEAEs will be tabulated by preferred term and system organ class. The maximum severity and frequency of TEAEs will be summarized by treatment.
Gastrointestinal disorders Dydpepsia	0.53% 1/188 • Number of events 1 • 16 Weeks All adverse events (AEs) will be coded to system organ class (SOC) and preferred terms (PT). A treatment-emergent AE (TEAE) is defined as an AE that was not present prior to treatment with the investigational digital device, but appeared following treatment or was present at treatment initiation but worsened during treatment. The frequency of TEAEs will be tabulated by preferred term and system organ class. The maximum severity and frequency of TEAEs will be summarized by treatment.	0.00% 0/190 • 16 Weeks All adverse events (AEs) will be coded to system organ class (SOC) and preferred terms (PT). A treatment-emergent AE (TEAE) is defined as an AE that was not present prior to treatment with the investigational digital device, but appeared following treatment or was present at treatment initiation but worsened during treatment. The frequency of TEAEs will be tabulated by preferred term and system organ class. The maximum severity and frequency of TEAEs will be summarized by treatment.
General disorders Fatigue	0.53% 1/188 • Number of events 1 • 16 Weeks All adverse events (AEs) will be coded to system organ class (SOC) and preferred terms (PT). A treatment-emergent AE (TEAE) is defined as an AE that was not present prior to treatment with the investigational digital device, but appeared following treatment or was present at treatment initiation but worsened during treatment. The frequency of TEAEs will be tabulated by preferred term and system organ class. The maximum severity and frequency of TEAEs will be summarized by treatment.	0.00% 0/190 • 16 Weeks All adverse events (AEs) will be coded to system organ class (SOC) and preferred terms (PT). A treatment-emergent AE (TEAE) is defined as an AE that was not present prior to treatment with the investigational digital device, but appeared following treatment or was present at treatment initiation but worsened during treatment. The frequency of TEAEs will be tabulated by preferred term and system organ class. The maximum severity and frequency of TEAEs will be summarized by treatment.
Infections and infestations Pharyngitis streptococcal	0.53% 1/188 • Number of events 1 • 16 Weeks All adverse events (AEs) will be coded to system organ class (SOC) and preferred terms (PT). A treatment-emergent AE (TEAE) is defined as an AE that was not present prior to treatment with the investigational digital device, but appeared following treatment or was present at treatment initiation but worsened during treatment. The frequency of TEAEs will be tabulated by preferred term and system organ class. The maximum severity and frequency of TEAEs will be summarized by treatment.	0.00% 0/190 • 16 Weeks All adverse events (AEs) will be coded to system organ class (SOC) and preferred terms (PT). A treatment-emergent AE (TEAE) is defined as an AE that was not present prior to treatment with the investigational digital device, but appeared following treatment or was present at treatment initiation but worsened during treatment. The frequency of TEAEs will be tabulated by preferred term and system organ class. The maximum severity and frequency of TEAEs will be summarized by treatment.
Infections and infestations Pneumonia	0.53% 1/188 • Number of events 2 • 16 Weeks All adverse events (AEs) will be coded to system organ class (SOC) and preferred terms (PT). A treatment-emergent AE (TEAE) is defined as an AE that was not present prior to treatment with the investigational digital device, but appeared following treatment or was present at treatment initiation but worsened during treatment. The frequency of TEAEs will be tabulated by preferred term and system organ class. The maximum severity and frequency of TEAEs will be summarized by treatment.	0.00% 0/190 • 16 Weeks All adverse events (AEs) will be coded to system organ class (SOC) and preferred terms (PT). A treatment-emergent AE (TEAE) is defined as an AE that was not present prior to treatment with the investigational digital device, but appeared following treatment or was present at treatment initiation but worsened during treatment. The frequency of TEAEs will be tabulated by preferred term and system organ class. The maximum severity and frequency of TEAEs will be summarized by treatment.
Infections and infestations Sinusitis	0.53% 1/188 • Number of events 1 • 16 Weeks All adverse events (AEs) will be coded to system organ class (SOC) and preferred terms (PT). A treatment-emergent AE (TEAE) is defined as an AE that was not present prior to treatment with the investigational digital device, but appeared following treatment or was present at treatment initiation but worsened during treatment. The frequency of TEAEs will be tabulated by preferred term and system organ class. The maximum severity and frequency of TEAEs will be summarized by treatment.	0.00% 0/190 • 16 Weeks All adverse events (AEs) will be coded to system organ class (SOC) and preferred terms (PT). A treatment-emergent AE (TEAE) is defined as an AE that was not present prior to treatment with the investigational digital device, but appeared following treatment or was present at treatment initiation but worsened during treatment. The frequency of TEAEs will be tabulated by preferred term and system organ class. The maximum severity and frequency of TEAEs will be summarized by treatment.
Nervous system disorders Headache	0.53% 1/188 • Number of events 1 • 16 Weeks All adverse events (AEs) will be coded to system organ class (SOC) and preferred terms (PT). A treatment-emergent AE (TEAE) is defined as an AE that was not present prior to treatment with the investigational digital device, but appeared following treatment or was present at treatment initiation but worsened during treatment. The frequency of TEAEs will be tabulated by preferred term and system organ class. The maximum severity and frequency of TEAEs will be summarized by treatment.	0.00% 0/190 • 16 Weeks All adverse events (AEs) will be coded to system organ class (SOC) and preferred terms (PT). A treatment-emergent AE (TEAE) is defined as an AE that was not present prior to treatment with the investigational digital device, but appeared following treatment or was present at treatment initiation but worsened during treatment. The frequency of TEAEs will be tabulated by preferred term and system organ class. The maximum severity and frequency of TEAEs will be summarized by treatment.
Nervous system disorders Neuropathy peripheral	0.53% 1/188 • Number of events 1 • 16 Weeks All adverse events (AEs) will be coded to system organ class (SOC) and preferred terms (PT). A treatment-emergent AE (TEAE) is defined as an AE that was not present prior to treatment with the investigational digital device, but appeared following treatment or was present at treatment initiation but worsened during treatment. The frequency of TEAEs will be tabulated by preferred term and system organ class. The maximum severity and frequency of TEAEs will be summarized by treatment.	0.00% 0/190 • 16 Weeks All adverse events (AEs) will be coded to system organ class (SOC) and preferred terms (PT). A treatment-emergent AE (TEAE) is defined as an AE that was not present prior to treatment with the investigational digital device, but appeared following treatment or was present at treatment initiation but worsened during treatment. The frequency of TEAEs will be tabulated by preferred term and system organ class. The maximum severity and frequency of TEAEs will be summarized by treatment.
Nervous system disorders Somnolence	0.00% 0/188 • 16 Weeks All adverse events (AEs) will be coded to system organ class (SOC) and preferred terms (PT). A treatment-emergent AE (TEAE) is defined as an AE that was not present prior to treatment with the investigational digital device, but appeared following treatment or was present at treatment initiation but worsened during treatment. The frequency of TEAEs will be tabulated by preferred term and system organ class. The maximum severity and frequency of TEAEs will be summarized by treatment.	0.53% 1/190 • Number of events 1 • 16 Weeks All adverse events (AEs) will be coded to system organ class (SOC) and preferred terms (PT). A treatment-emergent AE (TEAE) is defined as an AE that was not present prior to treatment with the investigational digital device, but appeared following treatment or was present at treatment initiation but worsened during treatment. The frequency of TEAEs will be tabulated by preferred term and system organ class. The maximum severity and frequency of TEAEs will be summarized by treatment.
Psychiatric disorders Panic attack	0.00% 0/188 • 16 Weeks All adverse events (AEs) will be coded to system organ class (SOC) and preferred terms (PT). A treatment-emergent AE (TEAE) is defined as an AE that was not present prior to treatment with the investigational digital device, but appeared following treatment or was present at treatment initiation but worsened during treatment. The frequency of TEAEs will be tabulated by preferred term and system organ class. The maximum severity and frequency of TEAEs will be summarized by treatment.	0.53% 1/190 • Number of events 1 • 16 Weeks All adverse events (AEs) will be coded to system organ class (SOC) and preferred terms (PT). A treatment-emergent AE (TEAE) is defined as an AE that was not present prior to treatment with the investigational digital device, but appeared following treatment or was present at treatment initiation but worsened during treatment. The frequency of TEAEs will be tabulated by preferred term and system organ class. The maximum severity and frequency of TEAEs will be summarized by treatment.
Vascular disorders Thrombosis	0.53% 1/188 • Number of events 1 • 16 Weeks All adverse events (AEs) will be coded to system organ class (SOC) and preferred terms (PT). A treatment-emergent AE (TEAE) is defined as an AE that was not present prior to treatment with the investigational digital device, but appeared following treatment or was present at treatment initiation but worsened during treatment. The frequency of TEAEs will be tabulated by preferred term and system organ class. The maximum severity and frequency of TEAEs will be summarized by treatment.	0.00% 0/190 • 16 Weeks All adverse events (AEs) will be coded to system organ class (SOC) and preferred terms (PT). A treatment-emergent AE (TEAE) is defined as an AE that was not present prior to treatment with the investigational digital device, but appeared following treatment or was present at treatment initiation but worsened during treatment. The frequency of TEAEs will be tabulated by preferred term and system organ class. The maximum severity and frequency of TEAEs will be summarized by treatment.

Additional Information

Dr. David Recker, Chief Medical Officer

metaMe Health

Phone: 1-888-463-8262

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place