Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2025-12-25 @ 8:54 PM
Study NCT ID:
NCT04723056
Status:
TERMINATED
Last Update Posted:
2025-05-28
First Post:
2021-01-20
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Zemedy Application for Irritable Bowel Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-04-16', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D043183', 'term': 'Irritable Bowel Syndrome'}], 'ancestors': [{'id': 'D003109', 'term': 'Colonic Diseases, Functional'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'nguyenlb@stanford.edu', 'phone': '650-736-0431', 'title': 'Linda Nguyen', 'organization': 'Stanford University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '24 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Experimental (TAU Plus CBT)', 'description': '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).', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 1, 'seriousNumAtRisk': 9, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control Group (TAU Only)', 'description': "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.", 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 0, 'seriousNumAtRisk': 9, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Abdominal pain', 'notes': 'Unrelated to treatment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'IBS-SSS at 8 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental (TAU Plus CBT)', 'description': '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).'}, {'id': 'OG001', 'title': 'Control Group (TAU Only)', 'description': "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."}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '215', 'groupId': 'OG000', 'lowerLimit': '174', 'upperLimit': '268'}, {'value': '171', 'groupId': 'OG001', 'lowerLimit': '151', 'upperLimit': '229'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '126', 'groupId': 'OG000', 'lowerLimit': '66', 'upperLimit': '171'}, {'value': '143.5', 'groupId': 'OG001', 'lowerLimit': '119.5', 'upperLimit': '197'}]}]}], 'analyses': [{'pValue': '0.282', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'The a priori threshold for statistical significance was \\<0.05.', 'groupDescription': 'Between-group analysis at week 8', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and at Week 8.', 'description': '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).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with data at the respective time point'}, {'type': 'SECONDARY', 'title': 'IBS-SSS at 24 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental (TAU Plus CBT)', 'description': '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).'}, {'id': 'OG001', 'title': 'Control Group (TAU Only)', 'description': "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."}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '215', 'groupId': 'OG000', 'lowerLimit': '174', 'upperLimit': '268'}, {'value': '171', 'groupId': 'OG001', 'lowerLimit': '151', 'upperLimit': '229'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '134', 'groupId': 'OG000', 'lowerLimit': '101', 'upperLimit': '160'}, {'value': '143.5', 'groupId': 'OG001', 'lowerLimit': '119.5', 'upperLimit': '197'}]}]}], 'analyses': [{'pValue': '0.217', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'The a priori threshold for statistical significance was \\<0.05.', 'groupDescription': 'Between-group analysis at week 24', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and at Week 24', 'description': '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).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with data at the respective time point'}, {'type': 'SECONDARY', 'title': 'Hospital Anxiety and Depression Scale (HADS) - Depression Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental (TAU Plus CBT)', 'description': '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).'}, {'id': 'OG001', 'title': 'Control Group (TAU Only)', 'description': "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."}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '7'}, {'value': '2', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '4'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '8'}, {'value': '5', 'groupId': 'OG001', 'lowerLimit': '3.5', 'upperLimit': '7.5'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '6'}, {'value': '1.5', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '3'}]}]}], 'analyses': [{'pValue': '0.462', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'The a priori threshold for statistical significance was \\<0.05.', 'groupDescription': 'Between-group analysis at week 8', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.179', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'The a priori threshold for statistical significance was \\<0.05.', 'groupDescription': 'Between-group analysis at week 24', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, week 8 and week 24', 'description': 'Assesses mood measured by the total distress score (score range: 0 to 21; \\<7 normal, 8-14 borderline, 15 or \\>15, abnormal).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with data at the respective time point'}, {'type': 'SECONDARY', 'title': 'Hospital Anxiety and Depression Scale (HADS) - Anxiety Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental (TAU Plus CBT)', 'description': '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).'}, {'id': 'OG001', 'title': 'Control Group (TAU Only)', 'description': "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."}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '11'}, {'value': '7', 'groupId': 'OG001', 'lowerLimit': '5', 'upperLimit': '10'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000', 'lowerLimit': '8', 'upperLimit': '10'}, {'value': '8', 'groupId': 'OG001', 'lowerLimit': '6', 'upperLimit': '14.5'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000', 'lowerLimit': '6', 'upperLimit': '11'}, {'value': '6.5', 'groupId': 'OG001', 'lowerLimit': '3', 'upperLimit': '10'}]}]}], 'analyses': [{'pValue': '.573', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'The a priori threshold for statistical significance was \\<0.05.', 'groupDescription': 'Between-group analysis at week 8', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'pValue': '.606', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'The a priori threshold for statistical significance was \\<0.05.', 'groupDescription': 'Between-group analysis at week 24', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, week 8 and week 24', 'description': 'Assesses mood measured by the total distress score (score range: 0 to 21; \\<7 normal, 8-14 borderline, 15 or \\>15, abnormal)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with data at the respective time point'}, {'type': 'SECONDARY', 'title': 'Cohen Perceived Stress Questionnaire (PSQ)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental (TAU Plus CBT)', 'description': '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).'}, {'id': 'OG001', 'title': 'Control Group (TAU Only)', 'description': "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."}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000', 'lowerLimit': '27', 'upperLimit': '34'}, {'value': '21', 'groupId': 'OG001', 'lowerLimit': '19', 'upperLimit': '27'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000', 'lowerLimit': '25', 'upperLimit': '35'}, {'value': '22', 'groupId': 'OG001', 'lowerLimit': '18', 'upperLimit': '28'}]}]}], 'analyses': [{'pValue': '.181', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'The a priori threshold for statistical significance was \\<0.05.', 'groupDescription': 'Between-group analysis at week 24', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'baseline, 24 weeks', 'description': "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)", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with data at the respective time point'}, {'type': 'SECONDARY', 'title': 'Work and Social Adjustment Scale (WSAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental (TAU Plus CBT)', 'description': '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).'}, {'id': 'OG001', 'title': 'Control Group (TAU Only)', 'description': "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."}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000', 'lowerLimit': '7', 'upperLimit': '16'}, {'value': '13', 'groupId': 'OG001', 'lowerLimit': '11', 'upperLimit': '18'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000', 'lowerLimit': '6', 'upperLimit': '14'}, {'value': '14.5', 'groupId': 'OG001', 'lowerLimit': '9', 'upperLimit': '16'}]}]}], 'analyses': [{'pValue': '.407', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'The a priori threshold for statistical significance was \\<0.05.', 'groupDescription': 'Between-group analysis at week 24', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, week 24', 'description': '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).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with data at the respective time point'}, {'type': 'SECONDARY', 'title': "Subject's Global Assessment of Relief (SGA)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental (TAU Plus CBT)', 'description': '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).'}, {'id': 'OG001', 'title': 'Control Group (TAU Only)', 'description': "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."}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '-1', 'upperLimit': '0'}, {'value': '1', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '1'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '-1', 'upperLimit': '1'}, {'value': '1.5', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '2'}]}]}], 'analyses': [{'pValue': '.643', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'The a priori threshold for statistical significance was \\<0.05.', 'groupDescription': 'Between-group analysis at week 24', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 24', 'description': 'Assesses global symptoms relief asking the question, "Overall, how do you feel?". Score range: -2 (no pain) to +2 (severe pain/discomfort).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with data at the respective time point'}, {'type': 'SECONDARY', 'title': 'Work Productivity and Activity Impairment (WPAI) Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental (TAU Plus CBT)', 'description': '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).'}, {'id': 'OG001', 'title': 'Control Group (TAU Only)', 'description': "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."}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.59', 'spread': '6.06', 'groupId': 'OG000'}, {'value': '3.57', 'spread': '4.65', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.6', 'spread': '4.1', 'groupId': 'OG000'}, {'value': '1.5', 'spread': '3.3', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.4', 'spread': '1.8', 'groupId': 'OG000'}, {'value': '0.96', 'spread': '1.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.625', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'The a priori threshold for statistical significance was \\<0.05.', 'groupDescription': 'Between-group analysis at week 8', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'pValue': '.707', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'The a priori threshold for statistical significance was \\<0.05.', 'groupDescription': 'Between-group analysis at week 24', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 8 weeks, 24 weeks', 'description': 'Assesses work productivity based on percentage of work days taken off due to health', 'unitOfMeasure': 'percentage of work time missed', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with data at the respective time point'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Had an Urgent Care, Emergency Department, or Physician Appointment Due to IBS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental (TAU Plus CBT)', 'description': '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).'}, {'id': 'OG001', 'title': 'Control Group (TAU Only)', 'description': "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."}], 'classes': [{'title': 'Urgent care', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Emergency Department', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Physician appointment', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24 months', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Experimental (TAU Plus CBT)', 'description': '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).'}, {'id': 'FG001', 'title': 'Control Group (TAU Only)', 'description': "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."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'Completed Week 8 Surveys', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'Completed Week 24 Surveys', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': '21 participants signed informed consent; 18 were randomized to a study arm.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Experimental (TAU Plus CBT)', 'description': '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).'}, {'id': 'BG001', 'title': 'Control Group (TAU Only)', 'description': "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."}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '36', 'groupId': 'BG000', 'lowerLimit': '31', 'upperLimit': '45'}, {'value': '34', 'groupId': 'BG001', 'lowerLimit': '29', 'upperLimit': '38'}, {'value': '35.5', 'groupId': 'BG002', 'lowerLimit': '29', 'upperLimit': '45'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}, {'title': 'Non-white', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-04-19', 'size': 799797, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-03-19T17:26', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized trial comparing Zemedy CBT app vs. Treatment as usual'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'whyStopped': 'Loss of funding', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-10-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2024-03-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-09', 'studyFirstSubmitDate': '2021-01-20', 'resultsFirstSubmitDate': '2025-03-27', 'studyFirstSubmitQcDate': '2021-01-22', 'lastUpdatePostDateStruct': {'date': '2025-05-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-05-09', 'studyFirstPostDateStruct': {'date': '2021-01-25', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-05-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'IBS-SSS at 8 Weeks', 'timeFrame': 'Baseline and at Week 8.', 'description': '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).'}], 'secondaryOutcomes': [{'measure': 'IBS-SSS at 24 Weeks', 'timeFrame': 'Baseline and at Week 24', 'description': '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).'}, {'measure': 'Hospital Anxiety and Depression Scale (HADS) - Depression Score', 'timeFrame': 'Baseline, week 8 and week 24', 'description': 'Assesses mood measured by the total distress score (score range: 0 to 21; \\<7 normal, 8-14 borderline, 15 or \\>15, abnormal).'}, {'measure': 'Hospital Anxiety and Depression Scale (HADS) - Anxiety Score', 'timeFrame': 'Baseline, week 8 and week 24', 'description': 'Assesses mood measured by the total distress score (score range: 0 to 21; \\<7 normal, 8-14 borderline, 15 or \\>15, abnormal)'}, {'measure': 'Cohen Perceived Stress Questionnaire (PSQ)', 'timeFrame': 'baseline, 24 weeks', 'description': "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)"}, {'measure': 'Work and Social Adjustment Scale (WSAS)', 'timeFrame': 'Baseline, week 24', 'description': '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).'}, {'measure': "Subject's Global Assessment of Relief (SGA)", 'timeFrame': 'Baseline, Week 24', 'description': 'Assesses global symptoms relief asking the question, "Overall, how do you feel?". Score range: -2 (no pain) to +2 (severe pain/discomfort).'}, {'measure': 'Work Productivity and Activity Impairment (WPAI) Questionnaire', 'timeFrame': 'Baseline, 8 weeks, 24 weeks', 'description': 'Assesses work productivity based on percentage of work days taken off due to health'}, {'measure': 'Number of Participants Who Had an Urgent Care, Emergency Department, or Physician Appointment Due to IBS', 'timeFrame': '24 months'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Irritable Bowel Syndrome', 'Cognitive Behavioral Therapy', 'Self Help'], 'conditions': ['IBS - Irritable Bowel Syndrome']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is investigate the effectiveness of Zemedy, a mobile application that enables the digital delivery of a CBT program to people with IBS.', 'detailedDescription': 'Irritable bowel syndrome (IBS) is defined as having recurrent abdominal pain associated with defecation or a change of bowel habits. The pathophysiology of IBS can be looked through the biopsychosocial model of disease which is defined by the complex interplay between genetic, cultural, environmental, and psychosocial factors.\n\nTreatment of IBS is multifaceted and ranges from exercise to dietary restrictions, however, psychological treatments to target the gut-brain axis such as cognitive-behavior therapy (CBT) have also been shown to be an effective therapy, and aims to address the psychological and environmental stressors that contribute to the symptoms. Therefore the purpose of the study is investigate the effectiveness of Zemedy, a mobile application that enables the digital delivery of a CBT program to people with IBS.\n\nCBT has been shown to reduce the severity of intractable IBS symptoms by as much as 70%. The investigators hope to learn whether the Zemedy mobile application is effective in the reduction of IBS. This will be measured based on their IBS Symptom Severity Scores (SSS) at week 8 compared to baseline.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Male and female patients \\>=18 years old.\n2. Meet Rome IV criteria for IBS for at least 6 months. No restrictions on type of IBS.\n3. English proficiency (in order to understand use of the application.\n4. Patient must be on a stable regimen for IBS for at least 30 days.\n5. Patients must own a smartphone (iOS or Android) in order to participate in the CBT application.\n\nExclusion Criteria:\n\n1. Laboratory or imaging evidence of an alternative explanation of patient's symptoms.\n2. Active gastrointestinal disease such as Crohn's disease, ulcerative colitis, history of complete colon resection, acute infection, or any disease that precludes participation in CBT application.\n3. Patient already undergoing cognitive behavioral therapy.\n4. Psychiatric hospitalization within 10 years.\n5. Current or past diagnosis of a major mental illness such as schizophrenia, bipolar disorder, personality disorder or substance abuse.\n6. Active (within the past 3 months) suicidal ideation.\n7. Prisoners or other detained individuals.\n8. Adults unable to consent.\n9. Pregnant people."}, 'identificationModule': {'nctId': 'NCT04723056', 'briefTitle': 'Zemedy Application for Irritable Bowel Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Zemedy - Evaluation of Zemedy, a Cognitive Behavioral Therapy-based Digital Therapeutic Application for the Treatment of Irritable Bowel Syndrome', 'orgStudyIdInfo': {'id': '59209'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control Group (TAU only)', 'description': "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."}, {'type': 'EXPERIMENTAL', 'label': 'Experimental (TAU plus CBT)', 'description': 'Subjects 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).', 'interventionNames': ['Device: Use of Zemedy Application']}], 'interventions': [{'name': 'Use of Zemedy Application', 'type': 'DEVICE', 'description': '8 weeks of CBT via the Zemedy Application.', 'armGroupLabels': ['Experimental (TAU plus CBT)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94063', 'city': 'Redwood City', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University School of Medicine', 'geoPoint': {'lat': 37.48522, 'lon': -122.23635}}], 'overallOfficials': [{'name': 'Linda Nguyen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Bold Health Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Linda Nguyen', 'investigatorAffiliation': 'Stanford University'}}}}