Outcome Evaluation of Solutions for Wellness and Team Solutions Program in Patients With Severe Mental Illness
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.
Other: Wellness Program
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||Outcome Evaluation of Solutions for Wellness and Team Solutions Program in Patients With Severe Mental Illness|
- 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 ]
- Systolic and diastolic blood pressure [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||September 2006|
|Study Completion Date:||January 2008|
|Primary Completion Date:||September 2007 (Final data collection date for primary outcome measure)|
|Active Comparator: Wellness Group||
Other: Wellness Program
36 weeks of educational and supportive interventions
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00661869
|United States, New York|
|Manhattan Psychiatric Center|
|New York, New York, United States, 10035|
|Principal Investigator:||Jean-Pierre Lindenmayer, M.D.||New York University School of Medicine & Manhattan Psychaitric Center|