Bipolar I Disorder
Conditions
Keywords
Bipolar I Disorder, Medical Risks, Integrated Risk Reduction Intervention, Currently in Remission, BMI
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALIRRI
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.
BEHAVIORALPCCM
Subjects will remain in their assigned treatment condition for 24 months.
Sponsors
National Institute of Mental Health (NIMH)
University of Pittsburgh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
1. Age 18 to 55 years 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 6. Current diagnosis or past history of anxiety disorder, eating disorder, or other psychiatric comorbidities will not be
Exclusion criteria
for participation, except those listed in the
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | Entry and every 6 months of participation for two years |
| 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. | Entry and every 6 months of participation for two years |
Secondary
| Measure | Time frame |
|---|---|
| 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. | 6, 12, and 18 month timepoints of participation |
| 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. | This is assessed by how many missed appointments the subject has for IRRI |
Countries
United States
Outcome results
None listed