Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
 
ClinicalTrials.gov Identifier: NCT00661869
Recruitment Status : Completed
First Posted : April 21, 2008
Last Update Posted : August 9, 2010
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by:
Manhattan Psychiatric Center

Tracking Information
First Submitted Date  ICMJE April 16, 2008
First Posted Date  ICMJE April 21, 2008
Last Update Posted Date August 9, 2010
Study Start Date  ICMJE September 2006
Actual Primary Completion Date September 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 18, 2008)
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 18, 2008)
Systolic and diastolic blood pressure [ Time Frame: 36 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Outcome Evaluation of Solutions for Wellness and Team Solutions Program in Patients With Severe Mental Illness
Official Title  ICMJE Outcome Evaluation of Solutions for Wellness and Team Solutions Program in Patients With Severe Mental Illness
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.
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Schizophrenia
  • Schizoaffective Disorder
  • Bipolar Disorder
Intervention  ICMJE Other: Wellness Program
36 weeks of educational and supportive interventions
Study Arms  ICMJE Active Comparator: Wellness Group
Intervention: Other: Wellness Program
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 18, 2008)
295
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2008
Actual Primary Completion Date September 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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;
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00661869
Other Study ID Numbers  ICMJE 05I/C51-3
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jean-Pierre Lindenmayer, Manhattan Psychiatric Center & NYU School of Medicine
Study Sponsor  ICMJE Manhattan Psychiatric Center
Collaborators  ICMJE Eli Lilly and Company
Investigators  ICMJE
Principal Investigator: Jean-Pierre Lindenmayer, M.D. New York University School of Medicine & Manhattan Psychaitric Center
PRS Account Manhattan Psychiatric Center
Verification Date August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP