Outcome Evaluation of Solutions for Wellness and Team Solutions Program in Patients With Severe Mental Illness (Wellness)
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|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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|