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OpenTrials
Completed

NCT Number: NCT00661869

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Manhattan Psychiatric Center

New York, 10035, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Exclusion criteria

  • Are > 65 years of age;
  • Are currently enrolled in the Intensive Psychiatric Services (IPS) program at Manhattan Psychiatric Center;

Treatment and study plan

Wellness Program

Other

36 weeks of educational and supportive interventions

Primary outcomes

  1. Pre and post-test knowledge assessments attained from each module

    Time frame: 36 weeks

  2. 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

Secondary outcomes

  1. Systolic and diastolic blood pressure

    Time frame: 36 weeks

Sponsors and collaborators

Lead sponsor

Manhattan Psychiatric Center

Other

Collaborators

  • Eli Lilly and Company

Registry information

Acronym: Wellness

Important dates

Study start
2006
Primary completion
2007
Study completion
2008
First posted
Apr 21, 2008
Registry last updated
Aug 9, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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