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

Sponsor

Manhattan Psychiatric Center (Other)

Overall Status

Completed

CT.gov ID

NCT00661869

Collaborator

Eli Lilly and Company (Industry)

295

Enrollment

Location

Arm

Duration (Months)

18.4

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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 Design

Study Type:

Interventional

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 :

Sep 1, 2006

Actual Primary Completion Date :

Sep 1, 2007

Actual Study Completion Date :

Jan 1, 2008

Arms and Interventions

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

Arm

Intervention/Treatment

Active Comparator: Wellness Group

Other: Wellness Program

36 weeks of educational and supportive interventions

Outcome Measures

Primary Outcome Measures

Pre and post-test knowledge assessments attained from each module [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)) [36 weeks]

Secondary Outcome Measures

Systolic and diastolic blood pressure [36 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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