Outcome Evaluation of Solutions for Wellness and Team Solutions Program in Patients With Severe Mental Illness (Wellness)
Primary Purpose
Schizophrenia, Schizoaffective Disorder, Bipolar Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Wellness Program
Sponsored by
About this trial
This is an interventional supportive care trial for Schizophrenia
Eligibility 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;
Sites / Locations
- Manhattan Psychiatric Center
Arms of the Study
Arm 1
Arm Type
Active Comparator
Arm Label
Wellness Group
Arm Description
Outcomes
Primary Outcome Measures
Pre and post-test knowledge assessments attained from each module
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))
Secondary Outcome Measures
Systolic and diastolic blood pressure
Full Information
NCT ID
NCT00661869
First Posted
April 16, 2008
Last Updated
August 6, 2010
Sponsor
Manhattan Psychiatric Center
Collaborators
Eli Lilly and Company
1. Study Identification
Unique Protocol Identification Number
NCT00661869
Brief Title
Outcome Evaluation of Solutions for Wellness and Team Solutions Program in Patients With Severe Mental Illness
Acronym
Wellness
Official Title
Outcome Evaluation of Solutions for Wellness and Team Solutions Program in Patients With Severe Mental Illness
Study Type
Interventional
2. Study Status
Record Verification Date
August 2010
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
September 2007 (Actual)
Study Completion Date
January 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Manhattan Psychiatric Center
Collaborators
Eli Lilly and Company
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Schizoaffective Disorder, Bipolar Disorder
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
295 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Wellness Group
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Wellness Program
Intervention Description
36 weeks of educational and supportive interventions
Primary Outcome Measure Information:
Title
Pre and post-test knowledge assessments attained from each module
Time Frame
36 weeks
Title
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
Secondary Outcome Measure Information:
Title
Systolic and diastolic blood pressure
Time Frame
36 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Pierre Lindenmayer, M.D.
Organizational Affiliation
New York University School of Medicine & Manhattan Psychaitric Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Manhattan Psychiatric Center
City
New York
State/Province
New York
ZIP/Postal Code
10035
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
15119908
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.
Results Reference
background
PubMed Identifier
12562575
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.
Results Reference
background
Links:
URL
http://130.219.250.123/pepweb/aboutus/index.htm
Description
The Partners for Excellence in Psychiatry (PEP): Neuroscience Treatment Team Partner (NTTP) and Complete Wellness National Training and Consultation Program
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Outcome Evaluation of Solutions for Wellness and Team Solutions Program in Patients With Severe Mental Illness
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