Ignite Creation Date:
2025-12-25 @ 1:06 AM
Ignite Modification Date:
2025-12-25 @ 11:18 PM
Study NCT ID:
NCT01329393
Status:
COMPLETED
Last Update Posted:
2020-03-30
First Post:
2011-02-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Benefits Management for People With Psychiatric Disabilities
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}, {'id': 'D001714', 'term': 'Bipolar Disorder'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016879', 'term': 'Salvage Therapy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 99}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-27', 'studyFirstSubmitDate': '2011-02-02', 'studyFirstSubmitQcDate': '2011-04-01', 'lastUpdatePostDateStruct': {'date': '2020-03-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-04-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in the Summed score on the Heinrich-Carpenter Quality of Life Measure', 'timeFrame': 'Change from Week 0 to Week 24', 'description': 'The Heinrich-Carpenter Quality of Life score is derived by summing ratings of individual items after a semi-structured interview. The possible score on any given interview is 0-126. It is a global measure of social functioning with higher scores indicating better functioning.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Disability', 'Social Security', 'Representative Payee'], 'conditions': ['Dual Diagnosis', 'Schizophrenia', 'Bipolar Disorder']}, 'descriptionModule': {'briefSummary': 'This stage 1 clinical trial will determine pilot efficacy, develop a therapy manual, and collect qualitative data concerning a brief money management intervention for people disabled by psychiatric illnesses.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Has received treatment for a psychiatric disorder within 60 days of enrollment\n* Receives SSI or SSDI payments totaling at least $600 per month\n* Has an identified outpatient clinician\n* Either i) Homeless within the past 3 months. Homeless is defined as having spent at least seven days in a shelter, outdoors (e.g. in a park, in a car), in a public or abandoned building (e.g. train station), or temporarily (less than a continuous month) housed by family or friends OR ii) Hospitalized within the past 3 months\n\nJustification for Inclusion Criteria: Homelessness and hospitalization are common reasons for payee assignment (Conrad, Matters et al. 1998). In a prior study, we found that a high proportion of hospitalized inpatients meet criteria for needing a payee (Rosen, Rosenheck et al. 2002a). There is no point enrolling clinically stable outpatients in this study because they are unlikely to need payees.\n\nExclusion Criteria:\n\n* Already has a conservator or representative payee\n* An application to assign a payee or conservator has been initiated\n* Unable to speak and understand English'}, 'identificationModule': {'nctId': 'NCT01329393', 'briefTitle': 'Benefits Management for People With Psychiatric Disabilities', 'organization': {'class': 'OTHER', 'fullName': 'Yale University'}, 'officialTitle': 'Benefits Management for People With Psychiatric Disabilities', 'orgStudyIdInfo': {'id': '0910005874'}, 'secondaryIdInfos': [{'id': 'R34MH083894', 'link': 'https://reporter.nih.gov/quickSearch/R34MH083894', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Benefits Management', 'description': 'Money-management intervention consisting of brief advice on budgeting, assessment of ability to follow a budget, and assessment of need for a representative payee.', 'interventionNames': ['Behavioral: Benefits Management']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Illness Management and Recovery', 'interventionNames': ['Behavioral: Illness Management and Recovery']}], 'interventions': [{'name': 'Benefits Management', 'type': 'BEHAVIORAL', 'description': 'Money-management intervention consisting of brief advice on budgeting, assessment of ability to follow a budget, and assessment of need for a representative payee.', 'armGroupLabels': ['Benefits Management']}, {'name': 'Illness Management and Recovery', 'type': 'BEHAVIORAL', 'description': 'Recovery Oriented Training in Biopsychosocial Model of Stress and How to Cope with Stress', 'armGroupLabels': ['Illness Management and Recovery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06102', 'city': 'Hartford', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Institute of Living', 'geoPoint': {'lat': 41.76371, 'lon': -72.68509}}], 'overallOfficials': [{'name': 'Marc I. Rosen, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yale University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yale University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}, {'name': 'VA Connecticut Healthcare System', 'class': 'FED'}], 'responsibleParty': {'type': 'SPONSOR'}}}}