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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00661869
Recruitment Status : Completed
First Posted : April 21, 2008
Last Update Posted : August 9, 2010
Eli Lilly and Company
Information provided by:
Manhattan Psychiatric Center

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.

Condition or disease Intervention/treatment Phase
Schizophrenia Schizoaffective Disorder Bipolar Disorder Other: Wellness Program Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 295 participants
Allocation: N/A
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Wellness Group Other: Wellness Program
36 weeks of educational and supportive interventions

Primary Outcome Measures :
  1. Pre and post-test knowledge assessments attained from each module [ Time Frame: 36 weeks ]
  2. 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 ]

Secondary Outcome Measures :
  1. Systolic and diastolic blood pressure [ Time Frame: 36 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Are at lease 18 years of age; ≤ 65 years.
  2. Are male or female
  3. Are currently hospitalized at Manhattan Psychiatric Center and attend daily treatment mall programs.
  4. Are fluent in the language of the investigator, and study staff (including testing administrators, group leaders and supervisors)
  5. Have a documented current psychiatric diagnosis as obtained from patient's medical charts and recorded by a qualified psychiatrist.
  6. Recently admitted patients will be included if their clinical state permits it.

Exclusion Criteria:

  1. Are > 65 years of age;
  2. Are currently enrolled in the Intensive Psychiatric Services (IPS) program at Manhattan Psychiatric Center;

Information from the National Library of Medicine

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 identifier (NCT number): NCT00661869

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United States, New York
Manhattan Psychiatric Center
New York, New York, United States, 10035
Sponsors and Collaborators
Manhattan Psychiatric Center
Eli Lilly and Company
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Principal Investigator: Jean-Pierre Lindenmayer, M.D. New York University School of Medicine & Manhattan Psychaitric Center
Additional Information:
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Responsible Party: Jean-Pierre Lindenmayer, Manhattan Psychiatric Center & NYU School of Medicine Identifier: NCT00661869    
Other Study ID Numbers: 05I/C51-3
First Posted: April 21, 2008    Key Record Dates
Last Update Posted: August 9, 2010
Last Verified: August 2010
Additional relevant MeSH terms:
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Bipolar Disorder
Psychotic Disorders
Mental Disorders
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Bipolar and Related Disorders