Outcome Evaluation of Solutions for Wellness and Team Solutions Program in Patients With Severe Mental Illness (Wellness)
|ClinicalTrials.gov Identifier: NCT00661869|
Recruitment Status : Completed
First Posted : April 21, 2008
Last Update Posted : August 9, 2010
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia Schizoaffective Disorder Bipolar Disorder||Other: Wellness Program||Not Applicable|
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
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||295 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Outcome Evaluation of Solutions for Wellness and Team Solutions Program in Patients With Severe Mental Illness|
|Study Start Date :||September 2006|
|Actual Primary Completion Date :||September 2007|
|Actual Study Completion Date :||January 2008|
|Active Comparator: Wellness Group||
Other: Wellness Program
36 weeks of educational and supportive interventions
- Pre and post-test knowledge assessments attained from each module [ Time Frame: 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)) [ Time Frame: 36 weeks ]
- Systolic and diastolic blood pressure [ Time Frame: 36 weeks ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|