Ignite Creation Date:
2025-12-24 @ 11:05 PM
Ignite Modification Date:
2025-12-31 @ 4:36 PM
Study NCT ID:
NCT00661869
Status:
COMPLETED
Last Update Posted:
2010-08-09
First Post:
2008-04-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Outcome Evaluation of Solutions for Wellness and Team Solutions Program in Patients With Severe 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': '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': 'D006293', 'term': 'Health Promotion'}], 'ancestors': [{'id': 'D006266', 'term': 'Health Education'}, {'id': 'D011314', 'term': 'Preventive Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 295}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-08', 'completionDateStruct': {'date': '2008-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-08-06', 'studyFirstSubmitDate': '2008-04-16', 'studyFirstSubmitQcDate': '2008-04-18', 'lastUpdatePostDateStruct': {'date': '2010-08-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-04-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pre and post-test knowledge assessments attained from each module', 'timeFrame': '36 weeks'}, {'measure': 'Change in weight, abdominal girth, blood pressure, metabolic markers (Glucose , Insulin, C-peptide, Glycohemoglobin, total cholesterol, total triglycerides, HDL and LDL, leptin, and free fatty acid (FFA))', 'timeFrame': '36 weeks'}], 'secondaryOutcomes': [{'measure': 'Systolic and diastolic blood pressure', 'timeFrame': '36 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Schizophrenia', 'Schizoaffective Disorder', 'Bipolar Disorder']}, 'referencesModule': {'references': [{'pmid': '15119908', 'type': 'BACKGROUND', 'citation': 'Menza M, Vreeland B, Minsky S, Gara M, Radler DR, Sakowitz M. Managing atypical antipsychotic-associated weight gain: 12-month data on a multimodal weight control program. J Clin Psychiatry. 2004 Apr;65(4):471-7.'}, {'pmid': '12562575', 'type': 'BACKGROUND', 'citation': 'Lindenmayer JP, Czobor P, Volavka J, Citrome L, Sheitman B, McEvoy JP, Cooper TB, Chakos M, Lieberman JA. Changes in glucose and cholesterol levels in patients with schizophrenia treated with typical or atypical antipsychotics. Am J Psychiatry. 2003 Feb;160(2):290-6. doi: 10.1176/appi.ajp.160.2.290.'}], 'seeAlsoLinks': [{'url': 'http://130.219.250.123/pepweb/aboutus/index.htm', 'label': 'The Partners for Excellence in Psychiatry (PEP): Neuroscience Treatment Team Partner (NTTP) and Complete Wellness National Training and Consultation Program'}]}, 'descriptionModule': {'briefSummary': 'Obesity is increasing at an alarming rate in patients with schizophrenia, possibly in association with the increased use of atypical antipsychotics. In order to address the weight and metabolic syndrome issues, Manhattan Psychiatric Center (MPC) has implemented the Solutions for Wellness and Team Solutions Program. This program is designed to create a supportive, educational and monitoring environment to stabilize both the psychiatric and medical conditions and to prepare patients for independent management of their psychiatric and physical health condition in the community.', 'detailedDescription': "The present program is divided into five detailed segments with three progressive levels, that provide a manualized lesson-by-lesson curriculum for implementation on the treatment mall.\n\n* Medication Education\n* Symptom recognition and management\n* Living Healthy\n* Interpersonal Skills\n* Discharge Preparation\n\nThe program comprised of detailed instructor and patient manuals, specific curriculums and pre- and post-tests to determine acquisition of the learned materials. All modules are imbedded in weekly small group sessions.\n\n* Each of the 5 modules are discussed in groups in weekly morning or afternoon session, Monday through Friday.\n* Each module is divided into three 12-week periods for a total of 36 sessions.\n* Upon completing 12 weeks at Level 1, each patient moves to Level 2 and then Level 3 for 12 weeks each.\n* Each group has two trained instructors.\n* Number of patients per group: ≤ 15.\n* Sessions are interspersed within the patient's regular treatment mall classes"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Are at lease 18 years of age; ≤ 65 years.\n2. Are male or female\n3. Are currently hospitalized at Manhattan Psychiatric Center and attend daily treatment mall programs.\n4. Are fluent in the language of the investigator, and study staff (including testing administrators, group leaders and supervisors)\n5. Have a documented current psychiatric diagnosis as obtained from patient's medical charts and recorded by a qualified psychiatrist.\n6. Recently admitted patients will be included if their clinical state permits it.\n\nExclusion Criteria:\n\n1. Are \\> 65 years of age;\n2. Are currently enrolled in the Intensive Psychiatric Services (IPS) program at Manhattan Psychiatric Center;"}, 'identificationModule': {'nctId': 'NCT00661869', 'acronym': 'Wellness', 'briefTitle': 'Outcome Evaluation of Solutions for Wellness and Team Solutions Program in Patients With Severe Mental Illness', 'organization': {'class': 'OTHER', 'fullName': 'Manhattan Psychiatric Center'}, 'officialTitle': 'Outcome Evaluation of Solutions for Wellness and Team Solutions Program in Patients With Severe Mental Illness', 'orgStudyIdInfo': {'id': '05I/C51-3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Wellness Group', 'interventionNames': ['Other: Wellness Program']}], 'interventions': [{'name': 'Wellness Program', 'type': 'OTHER', 'description': '36 weeks of educational and supportive interventions', 'armGroupLabels': ['Wellness Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10035', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Manhattan Psychiatric Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Jean-Pierre Lindenmayer, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'New York University School of Medicine & Manhattan Psychaitric Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Manhattan Psychiatric Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Jean-Pierre Lindenmayer', 'oldOrganization': 'Manhattan Psychiatric Center & NYU School of Medicine'}}}}