SchizophreniaWellnessNCT00661869
Outcome Evaluation of Solutions for Wellness and Team Solutions Program in Patients With Severe Mental Illness
A study testing Wellness Program in people with Schizophrenia and Schizoaffective Disorder, run by Manhattan Psychiatric Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder, Bipolar Disorder
- What is being tested?
- Wellness Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 295 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2006to Jan 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Are > 65 years of age;
- Are currently enrolled in the Intensive Psychiatric Services (IPS) program at Manhattan Psychiatric Center;
Trial locations and contacts
1 site in 1 country.
United States1 site
Manhattan Psychiatric Center
New York, New York, 10035
About this study
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.
Read the 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
- Conditions
- Schizophrenia, Schizoaffective Disorder, Bipolar Disorder
- Being tested
- Wellness Program
- Medical subject headings
- Schizophrenia, Psychotic Disorders, Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wellness ProgramOther
36 weeks of educational and supportive interventions
| Study group | Role | What they receive |
|---|---|---|
| Wellness Group | Active comparator | Not described Receives: Other: Wellness Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pre and post-test knowledge assessments attained from each module
Measured: 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))
Measured: 36 weeks
Secondary outcomes (1)
Systolic and diastolic blood pressure
Measured: 36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2008 (estimated)
- Study startSep 2006
- Primary completionSep 2007
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 295 participants (actual)
Sponsor and investigators
- Lead sponsor
- Manhattan Psychiatric Center
- Sponsor type
- University, hospital or other
- Collaborators
- Eli Lilly and Company
- Investigators
- Jean-Pierre Lindenmayer, M.D., Principal investigator, New York University School of Medicine & Manhattan Psychaitric Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00661869
- Sponsor's protocol ID
- 05I/C51-3
- Acronym
- Wellness
- Status last verified
- Aug 2010
- First submitted
- 16 Apr 2008
- Last updated
- 9 Aug 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 15119908Lindenmayer 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.
PubMed 12562575
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome Evaluation of Solutions for Wellness and Team Solutions Program in Patients With Severe Mental Illness
- ClinicalTrials.gov ID
- NCT00661869
- Acronym / sponsor ID
- Wellness / 05I/C51-3
- Conditions
- Schizophrenia, Schizoaffective Disorder, Bipolar Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 295 participants (actual)
- Lead sponsor
- Manhattan Psychiatric CenterUniversity, hospital or other
- Collaborators
- Eli Lilly and Company
- Study start
- Sep 2006
- Primary completion
- Sep 2007 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 21 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Wellness Group | Active comparator | Other: Wellness Program |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (2 listed)
- Are > 65 years of age;
- Are currently enrolled in the Intensive Psychiatric Services (IPS) program at Manhattan Psychiatric Center;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wellness Program36 weeks of educational and supportive interventions | Other | Wellness Group |
Primary outcome
Pre and post-test knowledge assessments attained from each module
Time frame: 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))
Time frame: 36 weeks
1 secondary outcome
Systolic and diastolic blood pressure
Time frame: 36 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2010.
- Background: PubMed 15119908Menza 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.
- Background: PubMed 12562575Lindenmayer 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.
- The Partners for Excellence in Psychiatry (PEP): Neuroscience Treatment Team Partner (NTTP) and Complete Wellness National Training and Consultation ProgramLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Pierre Lindenmayer, M.D. principal investigator
New York University School of Medicine & Manhattan Psychaitric Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wellness Program in people with Schizophrenia and Schizoaffective Disorder, run by Manhattan Psychiatric Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pre and post-test knowledge assessments attained from each module (time frame: 36 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00661869, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2010.