Outcome Evaluation of Solutions for Wellness and Team Solutions Program in Patients With Severe Mental Illness

Study Overview
=================
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

Official Title
-----------------
Outcome Evaluation of Solutions for Wellness and Team Solutions Program in Patients With Severe Mental Illness

Conditions
-----------------
Schizophrenia, Schizoaffective Disorder, Bipolar Disorder

Intervention / Treatment
-----------------
* Other: Wellness Program


Participation Criteria
=================
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;

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Wellness Group<br> | Other: Wellness Program<br>* 36 weeks of educational and supportive interventions<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pre and post-test knowledge assessments attained from each module |  | 36 weeks | 
| 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)) |  | 36 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systolic and diastolic blood pressure |  | 36 weeks |