Ignite Creation Date:
2025-12-25 @ 12:41 AM
Ignite Modification Date:
2026-03-01 @ 12:50 PM
Study NCT ID:
NCT03062267
Status:
COMPLETED
Last Update Posted:
2020-11-09
First Post:
2017-02-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effectiveness of a Mobile Texting Intervention for People With Serious Mental Illness
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011618', 'term': 'Psychotic Disorders'}, {'id': 'D012559', 'term': 'Schizophrenia'}, {'id': 'D001714', 'term': 'Bipolar Disorder'}, {'id': 'D003865', 'term': 'Depressive Disorder, Major'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D000068105', 'term': 'Bipolar and Related Disorders'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D003866', 'term': 'Depressive Disorder'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'dbenzeev@uw.edu', 'phone': '(206) 685-9655', 'title': 'Principal Investigator', 'organization': 'University of Washington'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '6 months.', 'eventGroups': [{'id': 'EG000', 'title': 'Treatment as Usual', 'description': 'Treatment as usual for 3 months.', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 0, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Mobile Interventionist', 'description': 'Participants will exchange text messages with a mobile interventionist throughout the day for 3 months.\n\nMobile Interventionist: A mobile interventionist is a trained clinician who provides supportive messaging through text messages via mobile devices (i.e. basic / smartphones)', 'otherNumAtRisk': 37, 'deathsNumAtRisk': 37, 'otherNumAffected': 0, 'seriousNumAtRisk': 37, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Psychiatric Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment as Usual', 'description': 'Treatment as usual for 3 months.'}, {'id': 'OG001', 'title': 'Mobile Interventionist', 'description': 'Participants will exchange text messages with a mobile interventionist throughout the day for 3 months.\n\nMobile Interventionist: A mobile interventionist is a trained clinician who provides supportive messaging through text messages via mobile devices (i.e. basic / smartphones)'}], 'classes': [{'title': 'Score at Baseline', 'categories': [{'measurements': [{'value': '5.2', 'spread': '11.2', 'groupId': 'OG000'}, {'value': '19.6', 'spread': '20.4', 'groupId': 'OG001'}]}]}, {'title': 'Score at 3 months', 'categories': [{'measurements': [{'value': '6.2', 'spread': '14.4', 'groupId': 'OG000'}, {'value': '15.1', 'spread': '16.7', 'groupId': 'OG001'}]}]}, {'title': 'Score at 6 months', 'categories': [{'measurements': [{'value': '.6', 'spread': '1.9', 'groupId': 'OG000'}, {'value': '17.9', 'spread': '19.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline to 3 months and 6 months', 'description': 'Assessed with the Psychotic Symptom Rating Scales (PSYRATS). The PSYRATS inquires about the specific dimensions of hallucinations and delusions. There are 17 items and each item is rated from 0 (absent) to 4 (severe). The PSYRATS has 2 subscales: the auditory hallucinations subscale (AHS) consisting of 11 items, and the delusions subscale (DS) consisting of 6 items. These subscale scores are added to create a total score ranging from 0-68. Higher scores indicate worse symptoms.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Psychiatric Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment as Usual', 'description': 'Treatment as usual for 3 months.'}, {'id': 'OG001', 'title': 'Mobile Interventionist', 'description': 'Participants will exchange text messages with a mobile interventionist throughout the day for 3 months.\n\nMobile Interventionist: A mobile interventionist is a trained clinician who provides supportive messaging through text messages via mobile devices (i.e. basic / smartphones)'}], 'classes': [{'title': 'Score at Baseline', 'categories': [{'measurements': [{'value': '18.5', 'spread': '13.7', 'groupId': 'OG000'}, {'value': '18.5', 'spread': '11.4', 'groupId': 'OG001'}]}]}, {'title': 'Score at 3 Months', 'categories': [{'measurements': [{'value': '17.2', 'spread': '11.3', 'groupId': 'OG000'}, {'value': '23.4', 'spread': '12.4', 'groupId': 'OG001'}]}]}, {'title': 'Score at 6 Months', 'categories': [{'measurements': [{'value': '15.5', 'spread': '11.2', 'groupId': 'OG000'}, {'value': '14.8', 'spread': '10.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline to 3 months and 6 months', 'description': 'Assessed with the Beck Depression Inventory (BDI). The Beck Depression Inventory is a psychometric test for measuring the severity of depression. There are 21 items, each rated from 0-3, and total scores range from 0-63. Higher scores indicate more severe depressive symptoms.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Recovery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment as Usual', 'description': 'Treatment as usual for 3 months.'}, {'id': 'OG001', 'title': 'Mobile Interventionist', 'description': 'Participants will exchange text messages with a mobile interventionist throughout the day for 3 months.\n\nMobile Interventionist: A mobile interventionist is a trained clinician who provides supportive messaging through text messages via mobile devices (i.e. basic / smartphones)'}], 'classes': [{'title': 'Score at Baseline', 'categories': [{'measurements': [{'value': '91.8', 'spread': '14.6', 'groupId': 'OG000'}, {'value': '89.8', 'spread': '17.3', 'groupId': 'OG001'}]}]}, {'title': 'Score at 3 Months', 'categories': [{'measurements': [{'value': '90.0', 'spread': '13.8', 'groupId': 'OG000'}, {'value': '92.9', 'spread': '15.5', 'groupId': 'OG001'}]}]}, {'title': 'Score at 6 Months', 'categories': [{'measurements': [{'value': '93.8', 'spread': '13.1', 'groupId': 'OG000'}, {'value': '94.4', 'spread': '14.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline to 3 months and 6 months', 'description': 'Assessed with the Recovery Assessment Scale (RAS). This scale measures mental health recovery. There are 24 items, each rated from 1 (disagree) to 5 (agree), and total scores range from 24-120. Higher scores indicate better recovery.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Satisfaction With Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment as Usual', 'description': 'Treatment as usual for 3 months.'}, {'id': 'OG001', 'title': 'Mobile Interventionist', 'description': 'Participants will exchange text messages with a mobile interventionist throughout the day for 3 months.\n\nMobile Interventionist: A mobile interventionist is a trained clinician who provides supportive messaging through text messages via mobile devices (i.e. basic / smartphones)'}], 'classes': [{'categories': [{'measurements': [{'value': '28.2', 'spread': '6.2', 'groupId': 'OG000'}, {'value': '30.1', 'spread': '6.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months', 'description': 'Assessed with satisfaction items established from previous SMI research. This measure consists of 5 items, each rated from 1 (strongly disagree) to 7 (strongly agree), and total scores range from 5-35. Higher scores indicate more satisfaction with treatment.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Treatment as Usual', 'description': 'Treatment as usual for 3 months.'}, {'id': 'FG001', 'title': 'Mobile Interventionist', 'description': 'Participants will exchange text messages with a mobile interventionist throughout the day for 3 months.\n\nMobile Interventionist: A mobile interventionist is a trained clinician who provides supportive messaging through text messages via mobile devices (i.e. basic / smartphones)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '37'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '32'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '5'}]}]}], 'preAssignmentDetails': 'No significant events to report that occurred after participant enrollment but prior to assignment of participants to an arm.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Treatment as Usual', 'description': 'Treatment as usual for 3 months.'}, {'id': 'BG001', 'title': 'Mobile Interventionist', 'description': 'Participants will exchange text messages with a mobile interventionist throughout the day for 3 months.\n\nMobile Interventionist: A mobile interventionist is a trained clinician who provides supportive messaging through text messages via mobile devices (i.e. basic / smartphones)'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '43.3', 'spread': '12.0', 'groupId': 'BG000'}, {'value': '45.4', 'spread': '11.1', 'groupId': 'BG001'}, {'value': '44.8', 'spread': '11.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Female', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}, {'title': 'Male', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-10-09', 'size': 220976, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-10-09T16:49', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 49}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2020-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-15', 'studyFirstSubmitDate': '2017-02-09', 'resultsFirstSubmitDate': '2020-10-15', 'studyFirstSubmitQcDate': '2017-02-20', 'lastUpdatePostDateStruct': {'date': '2020-11-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-10-15', 'studyFirstPostDateStruct': {'date': '2017-02-23', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-11-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Satisfaction With Treatment', 'timeFrame': '3 months', 'description': 'Assessed with satisfaction items established from previous SMI research. This measure consists of 5 items, each rated from 1 (strongly disagree) to 7 (strongly agree), and total scores range from 5-35. Higher scores indicate more satisfaction with treatment.'}], 'primaryOutcomes': [{'measure': 'Psychiatric Symptoms', 'timeFrame': 'Change from baseline to 3 months and 6 months', 'description': 'Assessed with the Psychotic Symptom Rating Scales (PSYRATS). The PSYRATS inquires about the specific dimensions of hallucinations and delusions. There are 17 items and each item is rated from 0 (absent) to 4 (severe). The PSYRATS has 2 subscales: the auditory hallucinations subscale (AHS) consisting of 11 items, and the delusions subscale (DS) consisting of 6 items. These subscale scores are added to create a total score ranging from 0-68. Higher scores indicate worse symptoms.'}, {'measure': 'Psychiatric Symptoms', 'timeFrame': 'Change from baseline to 3 months and 6 months', 'description': 'Assessed with the Beck Depression Inventory (BDI). The Beck Depression Inventory is a psychometric test for measuring the severity of depression. There are 21 items, each rated from 0-3, and total scores range from 0-63. Higher scores indicate more severe depressive symptoms.'}], 'secondaryOutcomes': [{'measure': 'Recovery', 'timeFrame': 'Change from baseline to 3 months and 6 months', 'description': 'Assessed with the Recovery Assessment Scale (RAS). This scale measures mental health recovery. There are 24 items, each rated from 1 (disagree) to 5 (agree), and total scores range from 24-120. Higher scores indicate better recovery.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['mhealth', 'texting intervention', 'mobile health', 'mobile mental health'], 'conditions': ['Schizoaffective Disorder', 'Schizophrenia', 'Bipolar Disorder', 'Major Depressive Disorder']}, 'descriptionModule': {'briefSummary': 'Testing an mHealth mobile interventionist texting program on illness management.', 'detailedDescription': 'The ultimate objective is to evaluate a validated mHealth intervention that can be realistically integrated into community mental health settings to increase the availability, reach, and broad impact of illness management approaches for people with serious mental illness (SMI).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Chart diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder, or major depressive disorder;\n2. 18 years or older;\n3. A rating of "3" or higher on one of three Patient Activation items;\n4. Ownership of a mobile phone with call/text plan (research staff will offer assistance in accessing the Federal Lifeline Assistance Program to people who do not have a mobile phone and/or call/text plan if they are otherwise eligible);\n5. Receiving community based treatment services.\n\nExclusion Criteria:\n\n1. Hearing, vision, or motor impairment that make it impossible to operate a mobile phone (determined using the individual\'s device for screening);\n2. English reading level below 4th grade (determined using the reading section from the Wide Range Achievement Test - 4th Edition (WRAT-4).'}, 'identificationModule': {'nctId': 'NCT03062267', 'briefTitle': 'Effectiveness of a Mobile Texting Intervention for People With Serious Mental Illness', 'organization': {'class': 'OTHER', 'fullName': 'University of Washington'}, 'officialTitle': 'Effectiveness of a Mobile Texting Intervention for People With Serious Mental Illness', 'orgStudyIdInfo': {'id': 'STUDY00001274'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Treatment as Usual', 'description': 'Treatment as usual for 3 months.'}, {'type': 'EXPERIMENTAL', 'label': 'Mobile Interventionist', 'description': 'Participants will exchange text messages with a mobile interventionist throughout the day for 3 months.', 'interventionNames': ['Other: Mobile Interventionist']}], 'interventions': [{'name': 'Mobile Interventionist', 'type': 'OTHER', 'description': 'A mobile interventionist is a trained clinician who provides supportive messaging through text messages via mobile devices (i.e. basic / smartphones)', 'armGroupLabels': ['Mobile Interventionist']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60290', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Thresholds', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '99207', 'city': 'Spokane', 'state': 'Washington', 'country': 'United States', 'facility': 'Frontier Behavioral Health', 'geoPoint': {'lat': 47.65966, 'lon': -117.42908}}], 'overallOfficials': [{'name': 'Dror Ben-Zeev, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Washington'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Washington', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, School of Medicine: Psychiatry and Behavioral Sciences', 'investigatorFullName': 'Dror Ben-Zeev', 'investigatorAffiliation': 'University of Washington'}}}}