Clinical trial NCT00661869: Outcome Evaluation of Solutions for Wellness and Team Solutions Program in Patients With Severe Mental Illness
Official title: Outcome Evaluation of Solutions for Wellness and Team Solutions Program in Patients With Severe Mental Illness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Schizoaffective Disorder
Bipolar Disorder
Lead sponsor: Manhattan Psychiatric Center
Sponsor class: OTHER
Collaborators: name: Eli Lilly and Company
First posted: 2008-04-21
Enrollment: 295
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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

Eligibility 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;

Primary outcomes:
measure: Pre and post-test knowledge assessments attained from each module
timeFrame: 36 weeks
measure: 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))
timeFrame: 36 weeks
Secondary outcomes:
measure: Systolic and diastolic blood pressure
timeFrame: 36 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: Manhattan Psychiatric Center
state: New York
Study officials:
affiliation: New York University School of Medicine & Manhattan Psychaitric Center
name: Jean-Pierre Lindenmayer, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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. doi: 10.1176/appi.ajp.160.2.290.