Reducing Medical Risks in Individuals With Bipolar Disorder - Full Study (MedRisk)
The primary aim of this project is to understand whether it is possible to reduce medical risk factors in adults with bipolar disorder and, in doing so, to improve psychiatric and functional outcomes. We will examine the role of behavioral risk factors and presumed behavioral mediators and moderators of health risk in individuals suffering from bipolar I disorder. The investigators will employ an innovative behavioral intervention with guideline based psychiatric care ( Integrated Risk Reduction Intervention - IRRI) in order to target modifiable medical risk factors.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Reducing Medical Risks in Individuals With Bipolar Disorder - Full Study|
- Integrated risk reduction intervention (IRRI), compared with psychiatric care with medical monitoring, will result in a larger decrease in medical risk factors and a greater improvement in sleep/wake and social rhythm disturbances. [ Time Frame: Entry and every 6 months of participation for two years ] [ Designated as safety issue: No ]
- Integrated risk reduction intervention compared with psychiatric care with medical monitoring will result in greater improvement in mood symptoms and functioning, particularly employment-related functioning. [ Time Frame: Entry and every 6 months of participation for two years ] [ Designated as safety issue: No ]
- The effect of integrated risk reduction intervention on improved mood symptoms and functioning will be mediated by the effect of integrated risk reduction intervention on medical risk factors and on sleep/wake and social rhythm disturbances. [ Time Frame: 6, 12, and 18 month timepoints of participation ] [ Designated as safety issue: No ]
- In turn, the effect of integrated risk reduction intervention on medical risk factors and on sleep/wake and social rhythm disturbances will be mediated by the regular participation and adherence of the subject to integrated risk reduction intervention. [ Time Frame: This is assessed by how many missed appointments the subject has for IRRI ] [ Designated as safety issue: No ]
|Study Start Date:||September 2008|
|Study Completion Date:||September 2013|
|Primary Completion Date:||September 2013 (Final data collection date for primary outcome measure)|
The integrated risk reduction intervention (IRRI) consists of three components:
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.
Other Name: Integrated Risk Reduction Intervention
Psychiatric Care with Medical Monitoring (PCMM)
The psychiatric care with medical monitoring condition (PCMM) consists of two components:
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.
Subjects will remain in their assigned treatment condition for 24 months.
Other Name: Psychiatric care with medical monitoring condition
IRRI is aimed at improving sleep/wake and social rhythm disturbance and achieving modest weight reduction by increasing physical activity and improving nutrition and dietary habits, while at the same time providing optimal psychiatric care and medical monitoring. This will allow us to investigate the role that improvements in sleep/wake and social rhythm regularity, diet, and physical activity have in improving psychiatric and functional outcomes. In order to examine another set or possible pathways (i.e., that it is the amelioration or psychiatric symptoms that leads to the improvements in physical health), we will contrast outcomes of subjects receiving IRRI with those of subjects receiving psychiatric care with medical monitoring (PCMM), which incorporates the same optimal psychiatric care plus monitoring of medical conditions. These aims will be achieved in a 24-month randomized treatment trial of 144 adult subjects with bipolar I disorder.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00746343
|United States, Pennsylvania|
|Western Psychiatric Institute and Clinic, University of Pittsburgh Medical Center|
|Pittsburgh, Pennsylvania, United States, 15213|
|Principal Investigator:||David J Kupfer, M.D.||University of Pittsburgh|