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

Schizophrenia Clinical Trial

— Wellness  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00661869
• Other study ID #: 05I/C51-3
• Status: Completed
• Phase: N/A
• First received: April 16, 2008
• Last updated: August 6, 2010
• Start date: September 2006
• Est. completion date: January 2008

Study information

• Verified date: August 2010
• Source: Manhattan Psychiatric Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 295
• Est. completion date: January 2008
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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;

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Bipolar Disorder
• Disease
• Mental Disorders
• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia

Intervention

Other:
• Wellness Program
36 weeks of educational and supportive interventions

Locations

Country	Name	City	State
United States	Manhattan Psychiatric Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Manhattan Psychiatric Center	Eli Lilly and Company

Country where clinical trial is conducted

United States, 

References & Publications (2)

Lindenmayer JP, Czobor P, Volavka J, Citrome L, Sheitman B, McEvoy JP, Cooper TB, Chakos M, Lieberman JA. Changes in glucose and cholesterol levels in patients with schizophrenia treated with typical or atypical antipsychotics. Am J Psychiatry. 2003 Feb;160(2):290-6. — View Citation

Menza M, Vreeland B, Minsky S, Gara M, Radler DR, Sakowitz M. Managing atypical antipsychotic-associated weight gain: 12-month data on a multimodal weight control program. J Clin Psychiatry. 2004 Apr;65(4):471-7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pre and post-test knowledge assessments attained from each module		36 weeks	No
Primary	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))		36 weeks	No
Secondary	Systolic and diastolic blood pressure		36 weeks	No

External Links

•   The Partners for Excellence in Psychiatry (PEP): Neuroscience Treatment Team Partner (NTTP) and Complete Wellness National Training and Consultation Program