Reducing Medical Risks in Individuals With Bipolar Disorder - Full Study

Bipolar I Disorder Clinical Trial

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Official title:

Reducing Medical Risks in Individuals With Bipolar Disorder - Full Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00746343
• Other study ID #: PRO08020071
• Secondary ID: R01MH081003
• Status: Completed
• Phase: N/A
• First received: September 3, 2008
• Last updated: December 11, 2013
• Start date: September 2008
• Est. completion date: September 2013

Study information

• Verified date: December 2013
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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 exclusion criteria below

Exclusion Criteria:

1. Ultra-rapid cycling (>8 episodes per year) bipolar I disorder

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bipolar Disorder
• Bipolar I Disorder

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Western Psychiatric Institute and Clinic, University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No