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