Outcome Evaluation of Solutions for Wellness and Team Solutions Program in Patients With Severe Mental Illness - Full Text View

Sponsors and Collaborators:	Manhattan Psychiatric Center Eli Lilly and Company
Information provided by:	Manhattan Psychiatric Center
ClinicalTrials.gov Identifier:	NCT00661869

Purpose

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.

Condition	Intervention
Schizophrenia Schizoaffective Disorder Bipolar Disorder	Other: Wellness Program

MedlinePlus related topics: Bipolar Disorder Mental Health Schizophrenia

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Open Label, Single Group Assignment, Efficacy Study
Official Title:	Outcome Evaluation of Solutions for Wellness and Team Solutions Program in Patients With Severe Mental Illness

Further study details as provided by Manhattan Psychiatric Center:

Primary Outcome Measures:

Pre and post-test knowledge assessments attained from each module [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]
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)) [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Systolic and diastolic blood pressure [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]

Enrollment:	295
Study Start Date:	September 2006
Study Completion Date:	January 2008
Primary Completion Date:	September 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Wellness Group: Active Comparator	Other: Wellness Program 36 weeks of educational and supportive interventions

Detailed Description:

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.

Medication Education
Symptom recognition and management
Living Healthy
Interpersonal Skills
Discharge Preparation

The 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.

Each of the 5 modules are discussed in groups in weekly morning or afternoon session, Monday through Friday.
Each module is divided into three 12-week periods for a total of 36 sessions.
Upon completing 12 weeks at Level 1, each patient moves to Level 2 and then Level 3 for 12 weeks each.
Each group has two trained instructors.
Number of patients per group: ≤ 15.
Sessions are interspersed within the patient's regular treatment mall classes

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Are at lease 18 years of age; ≤ 65 years.
Are male or female
Are currently hospitalized at Manhattan Psychiatric Center and attend daily treatment mall programs.
Are fluent in the language of the investigator, and study staff (including testing administrators, group leaders and supervisors)
Have a documented current psychiatric diagnosis as obtained from patient's medical charts and recorded by a qualified psychiatrist.
Recently admitted patients will be included if their clinical state permits it.

Exclusion Criteria:

Are > 65 years of age;
Are currently enrolled in the Intensive Psychiatric Services (IPS) program at Manhattan Psychiatric Center;

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00661869

Locations

United States, New York
Manhattan Psychiatric Center
New York, New York, United States, 10035

Sponsors and Collaborators

Manhattan Psychiatric Center

Eli Lilly and Company

Investigators

Principal Investigator:

Jean-Pierre Lindenmayer, M.D.

New York University School of Medicine & Manhattan Psychaitric Center

More Information

The Partners for Excellence in Psychiatry (PEP): Neuroscience Treatment Team Partner (NTTP) and Complete Wellness National Training and Consultation Program This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

Publications:

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.

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.

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.

Responsible Party:	Manhattan Psychiatric Center & NYU School of Medicine ( Jean-Pierre Lindenmayer )
Study ID Numbers:	05I/C51-3
Study First Received:	April 16, 2008
Last Updated:	April 18, 2008
ClinicalTrials.gov Identifier:	NCT00661869
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Schizophrenia
Affective Disorders, Psychotic
Mental Disorders
Bipolar Disorder

Mood Disorders
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:

Pathologic Processes
Disease

ClinicalTrials.gov processed this record on January 15, 2009