Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2025-12-25 @ 10:16 PM
Study NCT ID:
NCT00605358
Status:
COMPLETED
Last Update Posted:
2017-03-03
First Post:
2008-01-18
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Increasing Use of Mental Health Services
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003865', 'term': 'Depressive Disorder, Major'}], 'ancestors': [{'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jsirey@med.cornell.edu', 'phone': '9149974333', 'title': 'Dr. Jo Anne Sirey', 'organization': 'Weill Cornell Medicine'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse data were collected throughout the entire study period (three years).', 'description': 'All participants were systematically asked if they had been hospitalized since the prior research visit. All participants were also assessed for depression and suicidality.', 'eventGroups': [{'id': 'EG000', 'title': 'Open Door Intervention', 'description': 'Open Door intervention: Open Door intervention subjects will:\n\n1. receive an evaluation\n2. receive a referral to a local mental health provider\n3. identify barriers, set goals and problem-solve to achieve a mental health evaluation using available resources.', 'otherNumAtRisk': 80, 'otherNumAffected': 0, 'seriousNumAtRisk': 81, 'seriousNumAffected': 14}, {'id': 'EG001', 'title': 'Services Referral (Control)', 'description': 'Subjects who do not receive the Open Door intervention will receive:\n\n1. an evaluation\n2. referral to a local mental health provider\n3. booklet information on depression and mental health care, and will complete an application for HEAP, a Westchester County service that provides reduced rates from oil companies on heating to seniors.', 'otherNumAtRisk': 81, 'otherNumAffected': 0, 'seriousNumAtRisk': 80, 'seriousNumAffected': 17}], 'seriousEvents': [{'term': 'Hospitalization', 'notes': 'Hospitalizations occurred due to medical emergencies and falls', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 15, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 16, 'numAffected': 15}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Active Suicidal Ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Death', 'notes': 'Death was either natural or expected, NOT related to the study.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Primary Outcome is Engagement Defined as at Least One Visit With a Mental Health Provider Who Can Offer Treatment of Depression.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Open Door Intervention', 'description': 'Open Door intervention: Open Door intervention subjects will:\n\n1. receive an evaluation\n2. receive a referral to a local mental health provider\n3. identify barriers, set goals and problem-solve to achieve a mental health evaluation using available resources.'}, {'id': 'OG001', 'title': 'Services Referral (Control)', 'description': 'Subjects who do not receive the Open Door intervention will receive:\n\n1. an evaluation\n2. referral to a local mental health provider\n3. booklet information on depression and mental health care, and will complete an application for HEAP, a Westchester County service that provides reduced rates from oil companies on heating to seniors.'}], 'classes': [{'categories': [{'measurements': [{'value': '74.1', 'groupId': 'OG000'}, {'value': '56.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.018', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.4', 'ciLowerLimit': '1.17', 'ciUpperLimit': '4.93', 'groupDescription': 'Participants in the Open Door Intervention and the Services Referral condition were compared on rates of engagement in mental health services over the study follow-up period.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '12 and 24 weeks', 'description': 'Engagement was defined as at least one visit with a mental health provider, due to the fact that in some treatment settings, the initial evaluation and the onset of treatment both took place in the first visit.\n\nThe primary outcome, engagement, was counted if the participant had engaged in mental health treatment by EITHER 12 weeks OR 24 weeks, based on research suggesting that older adults may take up to 6 months to follow through on a referral.\n\nTherefore, while there is only a single primary outcome (engaged or not), it could be fulfilled at either of the two follow-up time points, at 12 or 24 weeks.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Open Door Intervention', 'description': 'Open Door intervention: Open Door intervention subjects will:\n\n1. receive an evaluation\n2. receive a referral to a local mental health provider\n3. identify barriers, set goals and problem-solve to achieve a mental health evaluation using available resources.'}, {'id': 'FG001', 'title': 'Services Referral (Control)', 'description': 'Subjects who do not receive the Open Door intervention will receive:\n\n1. an evaluation\n2. referral to a local mental health provider\n3. booklet information on depression and mental health care, and will complete an application for HEAP, a Westchester County service that provides reduced rates from oil companies on heating to seniors.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '81'}, {'groupId': 'FG001', 'numSubjects': '80'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '81'}, {'groupId': 'FG001', 'numSubjects': '80'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Older adults who were eligible for home-meals delivery were recruited into the study if they screened positive for depressive symptoms. Screens were completed by home meals staff, while all research interviews were completed by trained research assistants.', 'preAssignmentDetails': 'A number of participants were excluded from the trial after screening but prior to randomization, due to the following reasons:\n\nNon-English speaking, active suicidality, starting new antidepressant or therapy, cognitive impairment, substance abuse, psychosis.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '161', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Open Door Intervention', 'description': 'Open Door intervention: Open Door intervention subjects will:\n\n1. receive an evaluation\n2. receive a referral to a local mental health provider\n3. identify barriers, set goals and problem-solve to achieve a mental health evaluation using available resources.'}, {'id': 'BG001', 'title': 'Services Referral (Control)', 'description': 'Subjects who do not receive the Open Door intervention will receive:\n\n1. an evaluation\n2. referral to a local mental health provider\n3. booklet information on depression and mental health care, and will complete an application for HEAP, a Westchester County service that provides reduced rates from oil companies on heating to seniors.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '82.9', 'spread': '9.0', 'groupId': 'BG000'}, {'value': '81.0', 'spread': '9.5', 'groupId': 'BG001'}, {'value': '81.9', 'spread': '9.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Gender', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '67', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '116', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '75', 'groupId': 'BG000'}, {'value': '73', 'groupId': 'BG001'}, {'value': '148', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', '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': '17', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '64', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '117', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '81', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '161', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 161}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-12', 'studyFirstSubmitDate': '2008-01-18', 'resultsFirstSubmitDate': '2016-04-26', 'studyFirstSubmitQcDate': '2008-01-18', 'lastUpdatePostDateStruct': {'date': '2017-03-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-01-12', 'studyFirstPostDateStruct': {'date': '2008-01-31', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Primary Outcome is Engagement Defined as at Least One Visit With a Mental Health Provider Who Can Offer Treatment of Depression.', 'timeFrame': '12 and 24 weeks', 'description': 'Engagement was defined as at least one visit with a mental health provider, due to the fact that in some treatment settings, the initial evaluation and the onset of treatment both took place in the first visit.\n\nThe primary outcome, engagement, was counted if the participant had engaged in mental health treatment by EITHER 12 weeks OR 24 weeks, based on research suggesting that older adults may take up to 6 months to follow through on a referral.\n\nTherefore, while there is only a single primary outcome (engaged or not), it could be fulfilled at either of the two follow-up time points, at 12 or 24 weeks.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['geriatric depression'], 'conditions': ['Major Depression']}, 'referencesModule': {'references': [{'pmid': '15625220', 'type': 'BACKGROUND', 'citation': 'Sirey JA, Bruce ML, Alexopoulos GS. The Treatment Initiation Program: an intervention to improve depression outcomes in older adults. Am J Psychiatry. 2005 Jan;162(1):184-6. doi: 10.1176/appi.ajp.162.1.184.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to test the effectiveness of Open Door (previously known as the Treatment Initiation Program \\[TIP\\]), a brief psychosocial intervention to address the psychological barriers to care and improve the use of mental health services by depressed community elderly. The intervention is designed to help the older adult identify the barriers, problem-solve to find solutions and mobilize the motivation to seek help. Open Door was developed to work collaboratively with an older adult who is depressed to improve access and adherence to mental health treatment.', 'detailedDescription': 'The primary aim of this research study did not change from the original application; it is to conduct a randomized controlled trial of the effectiveness of a brief, psychosocial intervention on engagement in mental health care among homebound depressed older adults. Engagement is defined as accepting a referral and attending a visit with a provider who could provide traditional mental health care (medication or psychotherapy). The intervention, now called Open Door, was developed to work collaboratively with an older adult who has depressive symptoms to address the barriers to care with the aim of helping them consider a referral and engage in mental health care. In prior research, this intervention has been found to improve treatment participation, reduce depressive symptoms and increase adherence to antidepressant therapy among depressed older adults in primary care and outpatient psychiatric settings. We propose that Open Door will improve the access to mental health care by reducing psychological barriers, providing education about care, and managing the resignation associated with the symptoms of depression among community dwelling depressed elders. Additionally, we believe that despite the heterogeneity of mental health care that may be received, Open Door will be associated with reduced depressive symptoms by empowering the older adult to initiate care for him/herself.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 60 years and older\n* Homebound\n* Endorse depressive symptoms\n\nExclusion Criteria:\n\n* Presence of significant alcohol or substance abuse or psychotic disorder\n* High suicide risk, i.e. intent or plan to attempt suicide\n* Cognitive impairment\n* Inability to speak English\n* Aphasia interfering with communication.\n* Current use of antidepressants or psychotherapy'}, 'identificationModule': {'nctId': 'NCT00605358', 'acronym': 'OpenDoor', 'briefTitle': 'Increasing Use of Mental Health Services', 'organization': {'class': 'OTHER', 'fullName': 'Weill Medical College of Cornell University'}, 'officialTitle': 'Increasing Use of Mental Health Services by Community Dwelling Adults With Depression', 'orgStudyIdInfo': {'id': 'R01MH079265-01A1', 'link': 'https://reporter.nih.gov/quickSearch/R01MH079265-01A1', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Open Door Intervention', 'description': 'Subjects who receive the Open Door Intervention will work with the study counselor to identify barriers to participation in mental health treatment, set goals, and problem-solve, in addition to receiving a referral.', 'interventionNames': ['Behavioral: Open Door intervention']}, {'type': 'NO_INTERVENTION', 'label': 'Services Referral', 'description': 'Subjects who do not receive the Open Door intervention will receive:\n\n1. an evaluation\n2. referral to a local mental health provider\n3. booklet information on depression and mental health care, and will complete an application for HEAP, a Westchester County service that provides reduced rates from oil companies on heating to seniors.'}], 'interventions': [{'name': 'Open Door intervention', 'type': 'BEHAVIORAL', 'otherNames': ['West group'], 'description': 'Open Door intervention subjects will:\n\n1. receive an evaluation\n2. receive a referral to a local mental health provider\n3. identify barriers, set goals and problem-solve to achieve a mental health evaluation using available resources.', 'armGroupLabels': ['Open Door Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10605', 'city': 'White Plains', 'state': 'New York', 'country': 'United States', 'facility': 'Weill Cornell Medical College', 'geoPoint': {'lat': 41.03399, 'lon': -73.76291}}], 'overallOfficials': [{'name': 'Jo Anne Sirey, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Weill Medical College of Cornell University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Weill Medical College of Cornell University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Jo Anne Sirey', 'investigatorAffiliation': 'Weill Medical College of Cornell University'}}}}