Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2025-12-25 @ 10:57 PM
Study NCT ID:
NCT04068467
Status:
COMPLETED
Last Update Posted:
2021-08-11
First Post:
2019-08-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of mHealth for Serious Mental Illness
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}, {'id': 'D011618', 'term': 'Psychotic Disorders'}, {'id': 'D003865', 'term': 'Depressive Disorder, Major'}, {'id': 'D001714', 'term': 'Bipolar Disorder'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D000068105', 'term': 'Bipolar and Related Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 315}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2021-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-10', 'studyFirstSubmitDate': '2019-08-07', 'studyFirstSubmitQcDate': '2019-08-22', 'lastUpdatePostDateStruct': {'date': '2021-08-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Depressive Symptoms', 'timeFrame': 'Baseline, 30 days, 60 days', 'description': 'The Beck Depression Inventory is a self-reported 21-item inventory, scores range from 0-63 and items are summed to compute the total score. A higher score represents more depressive symptoms.'}, {'measure': 'Change in Paranoid Thinking', 'timeFrame': 'Baseline, 30 days, 60 days', 'description': 'The Green Paranoid Thoughts Scale Parts A \\& B is a 32-item scale, the total score is summed with a range of 16-80. A higher score represents more symptoms of paranoid thinking.'}, {'measure': 'Change in Anxiety Symptoms', 'timeFrame': 'Baseline, 30 days, 60 days', 'description': 'The Generalized Anxiety Disorder 7-item Scale is summed with a total score range of 0-21. Higher scores represent more symptoms of anxiety.'}, {'measure': 'Change in Psychotic Symptoms', 'timeFrame': 'Baseline, 30 days, 60 days', 'description': 'The Hamilton Program for Schizophrenia Voices Questionnaire is a 13-item questionnaire, 9 of the items are scored 0 (least severe or impairing) to 4 (most severe). The total score is intended to indicate the overall severity of psychotic symptoms. Total score range is 0-36. The remaining 4 items are intended to assess qualitative aspects.'}, {'measure': 'Participant Acceptability', 'timeFrame': '30 days', 'description': 'Participant Acceptability/Usability Ratings Scale is a 26-item scale measuring participant-rated acceptability of the intervention. Participants rate statements on a scale of Disagree (0), Neutral (1), or Agree (2). Items are summed to create a total score and a higher total score indicates greater acceptability.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Schizophrenia', 'Schizoaffective Disorder', 'Mobile Application', 'SMI', 'EHealth', 'E-Health', 'Health Technology', 'mHealth', 'm-Health', 'Mobile Health', 'Serious Mental Illness', 'Electronic Health'], 'conditions': ['Schizophrenia', 'Schizoaffective Disorder', 'Major Depressive Disorder', 'Bipolar Disorder']}, 'referencesModule': {'references': [{'pmid': '34766913', 'type': 'DERIVED', 'citation': 'Ben-Zeev D, Chander A, Tauscher J, Buck B, Nepal S, Campbell A, Doron G. A Smartphone Intervention for People With Serious Mental Illness: Fully Remote Randomized Controlled Trial of CORE. J Med Internet Res. 2021 Nov 12;23(11):e29201. doi: 10.2196/29201.'}]}, 'descriptionModule': {'briefSummary': 'This study is a waitlist control trial evaluating the acceptability and preliminary efficacy of a smartphone application with people with mental illness.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years or older\n* Owns an Android or iPhone smartphone with WiFi or 3G/4G capabilities (required for data transmission)\n* Has diagnosis of Schizophrenia, Schizoaffective Disorder, Bipolar Disorder or Major Depression\n* English speaker\n\nExclusion Criteria:\n\n* Does not live in the U.S.\n* Has already participated in the study\n* Unavailable for 60 days\n* Currently incarcerated or hospitalized'}, 'identificationModule': {'nctId': 'NCT04068467', 'briefTitle': 'Evaluation of mHealth for Serious Mental Illness', 'organization': {'class': 'OTHER', 'fullName': 'University of Washington'}, 'officialTitle': 'Evaluation of mHealth for Serious Mental Illness', 'orgStudyIdInfo': {'id': 'STUDY00006898'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active', 'description': 'Instructed to download the app and use the app daily for 30 days.', 'interventionNames': ['Other: Smartphone App']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Waitlist Control', 'description': 'Waitlist control.', 'interventionNames': ['Other: Waitlist Control']}], 'interventions': [{'name': 'Smartphone App', 'type': 'OTHER', 'description': 'The application consists of content areas focused on mental health.', 'armGroupLabels': ['Active']}, {'name': 'Waitlist Control', 'type': 'OTHER', 'description': 'Waitlist control', 'armGroupLabels': ['Waitlist Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98195', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'University of Washington', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Dror Ben-Zeev, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Washington'}]}, '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'}}}}