Trial Outcomes & Findings for Zemedy Application for Irritable Bowel Syndrome (NCT NCT04723056)

NCT ID: NCT04723056

Last Updated: 2025-05-28

Results Overview

Change in IBS symptoms based on the change in IBS symptom severity score (IBS-SSS) score at week 8 compared to baseline. Score range: 0-500. Higher score corresponds to more severe symptoms (75-175 = mild, 176-300 - moderate; \>300 = severe).

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 21 participants
• Primary outcome timeframe: Baseline and at Week 8.
• Results posted on: 2025-05-28

Participant Flow

21 participants signed informed consent; 18 were randomized to a study arm.

Participant milestones

Measure	Experimental (TAU Plus CBT) Participants who are in the Experimental Group will receive 8 weeks of CBT from the Zemedy mobile application in addition to their treatment as usual (TAU).	Control Group (TAU Only) Treatment as Usual (TAU) for IBS patients are tailored to each individual's needs and may involve treatment such as: dietary modification, exercise, medication, and anti-diarrheal therapy.
Overall Study STARTED	9	9
Overall Study Completed Week 8 Surveys	7	8
Overall Study Completed Week 24 Surveys	7	8
Overall Study COMPLETED	7	8
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Zemedy Application for Irritable Bowel Syndrome

Baseline characteristics by cohort

Measure	Experimental (TAU Plus CBT) n=9 Participants Participants who are in the Experimental Group will receive 8 weeks of CBT from the Zemedy mobile application in addition to their treatment as usual (TAU).	Control Group (TAU Only) n=9 Participants Treatment as Usual (TAU) for IBS patients are tailored to each individual's needs and may involve treatment such as: dietary modification, exercise, medication, and anti-diarrheal therapy.	Total n=18 Participants Total of all reporting groups
Age, Continuous	36 years n=5 Participants	34 years n=7 Participants	35.5 years n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	6 Participants n=7 Participants	13 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Race/Ethnicity, Customized White	9 Participants n=5 Participants	7 Participants n=7 Participants	16 Participants n=5 Participants
Race/Ethnicity, Customized Non-white	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	9 Participants n=5 Participants	9 Participants n=7 Participants	18 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and at Week 8.

Population: Participants with data at the respective time point

Change in IBS symptoms based on the change in IBS symptom severity score (IBS-SSS) score at week 8 compared to baseline. Score range: 0-500. Higher score corresponds to more severe symptoms (75-175 = mild, 176-300 - moderate; >300 = severe).

Outcome measures

Measure	Experimental (TAU Plus CBT) n=9 Participants Participants who are in the Experimental Group will receive 8 weeks of CBT from the Zemedy mobile application in addition to their treatment as usual (TAU).	Control Group (TAU Only) n=9 Participants Treatment as Usual (TAU) for IBS patients are tailored to each individual's needs and may involve treatment such as: dietary modification, exercise, medication, and anti-diarrheal therapy.
IBS-SSS at 8 Weeks Baseline	215 score on a scale Interval 174.0 to 268.0	171 score on a scale Interval 151.0 to 229.0
IBS-SSS at 8 Weeks Week 8	126 score on a scale Interval 66.0 to 171.0	143.5 score on a scale Interval 119.5 to 197.0

SECONDARY outcome

Timeframe: Baseline and at Week 24

Population: Participants with data at the respective time point

Change in IBS symptoms based on the change in IBS symptom severity score (IBS-SSS) score at week 24 compared to baseline. Score range: 0-500. Higher score corresponds to more severe symptoms (75-175 = mild, 176-300 - moderate; >300 = severe).

Outcome measures

Measure	Experimental (TAU Plus CBT) n=9 Participants Participants who are in the Experimental Group will receive 8 weeks of CBT from the Zemedy mobile application in addition to their treatment as usual (TAU).	Control Group (TAU Only) n=9 Participants Treatment as Usual (TAU) for IBS patients are tailored to each individual's needs and may involve treatment such as: dietary modification, exercise, medication, and anti-diarrheal therapy.
IBS-SSS at 24 Weeks Week 24	134 score on a scale Interval 101.0 to 160.0	143.5 score on a scale Interval 119.5 to 197.0
IBS-SSS at 24 Weeks Baseline	215 score on a scale Interval 174.0 to 268.0	171 score on a scale Interval 151.0 to 229.0

SECONDARY outcome

Timeframe: Baseline, week 8 and week 24

Population: Participants with data at the respective time point

Assesses mood measured by the total distress score (score range: 0 to 21; <7 normal, 8-14 borderline, 15 or >15, abnormal).

Outcome measures

Measure	Experimental (TAU Plus CBT) n=9 Participants Participants who are in the Experimental Group will receive 8 weeks of CBT from the Zemedy mobile application in addition to their treatment as usual (TAU).	Control Group (TAU Only) n=9 Participants Treatment as Usual (TAU) for IBS patients are tailored to each individual's needs and may involve treatment such as: dietary modification, exercise, medication, and anti-diarrheal therapy.
Hospital Anxiety and Depression Scale (HADS) - Depression Score Baseline	6 score on a scale Interval 4.0 to 7.0	2 score on a scale Interval 2.0 to 4.0
Hospital Anxiety and Depression Scale (HADS) - Depression Score Week 8	7 score on a scale Interval 4.0 to 8.0	5 score on a scale Interval 3.5 to 7.5
Hospital Anxiety and Depression Scale (HADS) - Depression Score Week 24	5 score on a scale Interval 3.0 to 6.0	1.5 score on a scale Interval 1.0 to 3.0

SECONDARY outcome

Timeframe: Baseline, week 8 and week 24

Population: Participants with data at the respective time point

Assesses mood measured by the total distress score (score range: 0 to 21; <7 normal, 8-14 borderline, 15 or >15, abnormal)

Outcome measures

Measure	Experimental (TAU Plus CBT) n=9 Participants Participants who are in the Experimental Group will receive 8 weeks of CBT from the Zemedy mobile application in addition to their treatment as usual (TAU).	Control Group (TAU Only) n=9 Participants Treatment as Usual (TAU) for IBS patients are tailored to each individual's needs and may involve treatment such as: dietary modification, exercise, medication, and anti-diarrheal therapy.
Hospital Anxiety and Depression Scale (HADS) - Anxiety Score Week 8	9 score on a scale Interval 8.0 to 10.0	8 score on a scale Interval 6.0 to 14.5
Hospital Anxiety and Depression Scale (HADS) - Anxiety Score Week 24	8 score on a scale Interval 6.0 to 11.0	6.5 score on a scale Interval 3.0 to 10.0
Hospital Anxiety and Depression Scale (HADS) - Anxiety Score Baseline	10 score on a scale Interval 3.0 to 11.0	7 score on a scale Interval 5.0 to 10.0

SECONDARY outcome

Timeframe: baseline, 24 weeks

Population: Participants with data at the respective time point

Measures degree situation's in one's life are seen as stressful (score range: 0 to 40; 0-13 = low stress, 14-26 = moderate stress, 27-40 = high stress)

Outcome measures

Measure	Experimental (TAU Plus CBT) n=9 Participants Participants who are in the Experimental Group will receive 8 weeks of CBT from the Zemedy mobile application in addition to their treatment as usual (TAU).	Control Group (TAU Only) n=9 Participants Treatment as Usual (TAU) for IBS patients are tailored to each individual's needs and may involve treatment such as: dietary modification, exercise, medication, and anti-diarrheal therapy.
Cohen Perceived Stress Questionnaire (PSQ) Week 24	29 score on a scale Interval 25.0 to 35.0	22 score on a scale Interval 18.0 to 28.0
Cohen Perceived Stress Questionnaire (PSQ) Baseline	32 score on a scale Interval 27.0 to 34.0	21 score on a scale Interval 19.0 to 27.0

SECONDARY outcome

Timeframe: Baseline, week 24

Population: Participants with data at the respective time point

Measures the effect of IBS on ability to work and manage at home, participate in social and private leisure activities and maintain relationships. Score range: 0 to 40 (<10 subclinical/mild, 10-20 significant, >20 severe).

Outcome measures

Measure	Experimental (TAU Plus CBT) n=9 Participants Participants who are in the Experimental Group will receive 8 weeks of CBT from the Zemedy mobile application in addition to their treatment as usual (TAU).	Control Group (TAU Only) n=9 Participants Treatment as Usual (TAU) for IBS patients are tailored to each individual's needs and may involve treatment such as: dietary modification, exercise, medication, and anti-diarrheal therapy.
Work and Social Adjustment Scale (WSAS) Baseline	14 score on a scale Interval 7.0 to 16.0	13 score on a scale Interval 11.0 to 18.0
Work and Social Adjustment Scale (WSAS) Week 24	9 score on a scale Interval 6.0 to 14.0	14.5 score on a scale Interval 9.0 to 16.0

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: Participants with data at the respective time point

Assesses global symptoms relief asking the question, "Overall, how do you feel?". Score range: -2 (no pain) to +2 (severe pain/discomfort).

Outcome measures

Measure	Experimental (TAU Plus CBT) n=9 Participants Participants who are in the Experimental Group will receive 8 weeks of CBT from the Zemedy mobile application in addition to their treatment as usual (TAU).	Control Group (TAU Only) n=9 Participants Treatment as Usual (TAU) for IBS patients are tailored to each individual's needs and may involve treatment such as: dietary modification, exercise, medication, and anti-diarrheal therapy.
Subject's Global Assessment of Relief (SGA) Baseline	0 score on a scale Interval -1.0 to 0.0	1 score on a scale Interval 0.0 to 1.0
Subject's Global Assessment of Relief (SGA) Week 24	0 score on a scale Interval -1.0 to 1.0	1.5 score on a scale Interval 0.0 to 2.0

SECONDARY outcome

Timeframe: Baseline, 8 weeks, 24 weeks

Population: Participants with data at the respective time point

Assesses work productivity based on percentage of work days taken off due to health

Outcome measures

Measure	Experimental (TAU Plus CBT) n=9 Participants Participants who are in the Experimental Group will receive 8 weeks of CBT from the Zemedy mobile application in addition to their treatment as usual (TAU).	Control Group (TAU Only) n=9 Participants Treatment as Usual (TAU) for IBS patients are tailored to each individual's needs and may involve treatment such as: dietary modification, exercise, medication, and anti-diarrheal therapy.
Work Productivity and Activity Impairment (WPAI) Questionnaire Baseline	9.59 percentage of work time missed Standard Deviation 6.06	3.57 percentage of work time missed Standard Deviation 4.65
Work Productivity and Activity Impairment (WPAI) Questionnaire Week 8	2.6 percentage of work time missed Standard Deviation 4.1	1.5 percentage of work time missed Standard Deviation 3.3
Work Productivity and Activity Impairment (WPAI) Questionnaire Week 24	1.4 percentage of work time missed Standard Deviation 1.8	0.96 percentage of work time missed Standard Deviation 1.9

SECONDARY outcome

Timeframe: 24 months

Outcome measures

Measure	Experimental (TAU Plus CBT) n=9 Participants Participants who are in the Experimental Group will receive 8 weeks of CBT from the Zemedy mobile application in addition to their treatment as usual (TAU).	Control Group (TAU Only) n=9 Participants Treatment as Usual (TAU) for IBS patients are tailored to each individual's needs and may involve treatment such as: dietary modification, exercise, medication, and anti-diarrheal therapy.
Number of Participants Who Had an Urgent Care, Emergency Department, or Physician Appointment Due to IBS Urgent care	0 Participants	0 Participants
Number of Participants Who Had an Urgent Care, Emergency Department, or Physician Appointment Due to IBS Emergency Department	1 Participants	0 Participants
Number of Participants Who Had an Urgent Care, Emergency Department, or Physician Appointment Due to IBS Physician appointment	0 Participants	0 Participants

Adverse Events

Experimental (TAU Plus CBT)

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Control Group (TAU Only)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Experimental (TAU Plus CBT) n=9 participants at risk Participants who are in the Experimental Group will receive 8 weeks of CBT from the Zemedy mobile application in addition to their treatment as usual (TAU).	Control Group (TAU Only) n=9 participants at risk Treatment as Usual (TAU) for IBS patients are tailored to each individual's needs and may involve treatment such as: dietary modification, exercise, medication, and anti-diarrheal therapy.
Gastrointestinal disorders Abdominal pain	11.1% 1/9 • 24 weeks	0.00% 0/9 • 24 weeks

Additional Information

Linda Nguyen

Stanford University

Phone: 650-736-0431

Email: nguyenlb@stanford.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place