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

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by:
Manhattan Psychiatric Center
ClinicalTrials.gov Identifier:
NCT00661869
First received: April 16, 2008
Last updated: August 6, 2010
Last verified: August 2010
  Purpose

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 Intervention
Schizophrenia
Schizoaffective Disorder
Bipolar Disorder
Other: Wellness Program

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Manhattan Psychiatric Center:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Systolic and diastolic blood pressure [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]

Enrollment: 295
Study Start Date: September 2006
Study Completion Date: January 2008
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Wellness Group Other: Wellness Program
36 weeks of educational and supportive interventions

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
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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;
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00661869

Locations
United States, New York
Manhattan Psychiatric Center
New York, New York, United States, 10035
Sponsors and Collaborators
Manhattan Psychiatric Center
Eli Lilly and Company
Investigators
Principal Investigator: Jean-Pierre Lindenmayer, M.D. New York University School of Medicine & Manhattan Psychaitric Center
  More Information

Additional Information:
Publications:
Responsible Party: Jean-Pierre Lindenmayer, Manhattan Psychiatric Center & NYU School of Medicine
ClinicalTrials.gov Identifier: NCT00661869     History of Changes
Other Study ID Numbers: 05I/C51-3
Study First Received: April 16, 2008
Last Updated: August 6, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Mental Disorders
Bipolar Disorder
Psychotic Disorders
Schizophrenia
Affective Disorders, Psychotic
Mood Disorders
Schizophrenia and Disorders with Psychotic Features
Pharmaceutical Solutions
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 20, 2014