Reducing Medical Risks in Individuals With Bipolar Disorder - Full Study
NCT ID: NCT00746343
Last Updated: 2013-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
122 participants
INTERVENTIONAL
2008-09-30
2013-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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IRRI
The integrated risk reduction intervention (IRRI) consists of three components:
1. psychiatric treatment by a study psychiatrist
2. assessment, referral, monitoring, and coordination by a certified registered nurse practitioner (CRNP) of medical treatment provided by the subject's own primary care physician
3. a healthy lifestyle behaviors program delivered by a lifestyle coach. The treating psychiatrist will work in collaboration with a CRNP and a lifestyle coach. The CRNP will assess and monitor the subject's medical needs and refer the subject to their primary care physician for care and will follow-up on adherence to the medical treatment recommendations. The CRNP will be responsible for coordinating the psychopharmacological care provided by the psychiatrist, the healthy lifestyle behaviors program that will be delivered by the lifestyle coach, and the medical care provided by the subject's PCP.
IRRI
Subjects will remain in their assigned treatment condition for 24 months. IRRI subjects will meet with the lifestyle coach 25-27 times throughout the duration of the study.
PCCM
Psychiatric Care with Medical Monitoring (PCMM)
The psychiatric care with medical monitoring condition (PCMM) consists of two components:
1. psychiatric treatment by a study psychiatrist
2. assessment and referral by a psychiatric research nurse for medical treatment provided by the subject's own primary care physician.
The treating psychiatrist will be assisted by a psychiatric nurse clinician who will assess and monitor the subject's medical needs and refer the subject to their primary care physician for care.
PCCM
Subjects will remain in their assigned treatment condition for 24 months.
Interventions
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IRRI
Subjects will remain in their assigned treatment condition for 24 months. IRRI subjects will meet with the lifestyle coach 25-27 times throughout the duration of the study.
PCCM
Subjects will remain in their assigned treatment condition for 24 months.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Body mass index (BMI) \>25
3. Meets DSM-IV criteria for lifetime bipolar I disorder
4. Is in remission (with possible sub-threshold symptoms), i.e., as a HRDS-25 \< or equal to 10, YMRS \< or equal to 8, and CGI-BP-S \<3 for two weeks
5. Able to give basic informed consent
Exclusion Criteria
2. Presence of pervasive developmental disorder, antisocial personality disorder, current substance dependence or abuse, and organic mental disorder
3. Unstable and severe medical illness that requires immediate and intensive medical attention, for instance, a subject with a terminal illness or a subject with severe and unstabilized coronary artery disease; these subjects will be immediately referred to the most appropriate medical and psychiatric treatment. When appropriate, the subjects can be reconsidered for inclusion in the study if/when their medical condition becomes compatible with participation in a protocol-driven research study
4. Unwilling or unable to comply with study requirements (i.e., complete forms, attend scheduled evaluations)
5. Not competent to provide informed consent in the opinion of the investigator
6. Women who are planning to become pregnant, currently pregnant, or breast-feeding
18 Years
55 Years
ALL
No
Sponsors
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National Institute of Mental Health (NIMH)
NIH
University of Pittsburgh
OTHER
Responsible Party
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Principal Investigators
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David J Kupfer, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh
Locations
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Western Psychiatric Institute and Clinic, University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Countries
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Other Identifiers
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PRO08020071
Identifier Type: -
Identifier Source: org_study_id