Ignite Creation Date:
2025-12-24 @ 4:20 PM
Ignite Modification Date:
2025-12-28 @ 7:39 AM
Study NCT ID:
NCT00400166
Status:
COMPLETED
Last Update Posted:
2009-06-12
First Post:
2006-11-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Recovery Guide Intervention for Recurrent Psychiatric Hospitalization
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}, {'id': 'D011618', 'term': 'Psychotic Disorders'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 71}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-06', 'completionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-06-10', 'studyFirstSubmitDate': '2006-11-15', 'studyFirstSubmitQcDate': '2006-11-15', 'lastUpdatePostDateStruct': {'date': '2009-06-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-11-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of hospitalizations', 'timeFrame': '9 months'}], 'secondaryOutcomes': [{'measure': 'Sense of community', 'timeFrame': 'Baseline, 3 and 9 months'}, {'measure': 'Motivation for change', 'timeFrame': 'Baseline, 3 and 9 months'}, {'measure': 'Social functioning', 'timeFrame': 'Baseline, 3 abd 9 months'}, {'measure': 'Hope', 'timeFrame': 'Baseline, 3 and 9 months'}, {'measure': 'Self-determination', 'timeFrame': 'Baseline, 3 and 9 months'}, {'measure': 'Functional status', 'timeFrame': 'Baseline, 3 and 9 months'}, {'measure': 'Treatment relationship', 'timeFrame': 'Baseline, 3 and 9 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Peer support', 'Psychiatric disability', 'Mutual support', 'Psychiatric Rehabilitation'], 'conditions': ['Schizophrenia', 'Schizoaffective Disorder', 'Bipolar Disorder', 'Psychotic Depression']}, 'referencesModule': {'references': [{'pmid': '29656708', 'type': 'DERIVED', 'citation': "O'Connell MJ, Sledge WH, Staeheli M, Sells D, Costa M, Wieland M, Davidson L. Outcomes of a Peer Mentor Intervention for Persons With Recurrent Psychiatric Hospitalization. Psychiatr Serv. 2018 Jul 1;69(7):760-767. doi: 10.1176/appi.ps.201600478. Epub 2018 Apr 16."}], 'seeAlsoLinks': [{'url': 'http://www.yale.edu/prch', 'label': 'Yale Program for Recovery and Community Health'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether Recovery Guide support services are effective in promoting recovery and social integration among psychiatrically disabled individuals who experience high rates of inpatient hospitalizations.', 'detailedDescription': 'The paradigm shift in mental health treatment from a deficit-and institution- based framework to a recovery and community integration frame necessitates new models of "case management" practices. The Recovery Guide model is just such a model. Beyond theoretical frameworks, the effectiveness of Recovery Guides has not been well studied. It is the intent of this study to conduct a randomized trial examining the effects of Recovery Guides on community tenure and integration. Furthermore, it is the intent of this study to to establish fidelity criteria.\n\nComparison(s): Recovery Guide services in addition to treatment as usual, compared to treatment as usual.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age or older\n* Currently admitted in the Yale-New Haven Psychiatric Hospital (YNHPH)\n* A history of two or more prior admissions within the past 18 months\n* Proficient in the use of the English language\n* A DSM-IV diagnosis of Schizophrenia, Schizoaffective Disorder, Psychotic Disorder NOS, or Major Depressive Disorder with Psychotic Features\n\nExclusion Criteria:\n\n* Inability to give signed, written consent\n* Primary DSM-IV diagnosis of substance abuse/dependence'}, 'identificationModule': {'nctId': 'NCT00400166', 'briefTitle': 'Recovery Guide Intervention for Recurrent Psychiatric Hospitalization', 'organization': {'class': 'OTHER', 'fullName': 'Yale University'}, 'officialTitle': 'Recovery Guide Intervention for Recurrent Psychiatric Hospitalization', 'orgStudyIdInfo': {'id': '0607001641'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Recovery Mentor: peer-based supportive care', 'interventionNames': ['Behavioral: Recovery Mentor']}, {'type': 'NO_INTERVENTION', 'label': '0', 'description': 'No Recovery Mentor, services as usual'}], 'interventions': [{'name': 'Recovery Mentor', 'type': 'BEHAVIORAL', 'description': 'Provided Recovery Mentor services', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06519', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale-New Haven Psychiatric Hospital', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}], 'overallOfficials': [{'name': 'William H Sledge, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yale University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yale University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Connecticut State, Department of Mental Health and Addiction Services', 'class': 'OTHER_GOV'}, {'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'William H. Sledge, M.D.; Director, Yale Psychiatric Hospital; Chair, Yale Department of Psychiatry; George D & Esther S Gross Professor of Psychiatry', 'oldOrganization': 'Yale University School of Medicine'}}}}