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Reducing Medical Risks in Individuals With Bipolar Disorder - Full Study (MedRisk)

Primary Purpose

Bipolar I Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
IRRI
PCCM
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bipolar I Disorder focused on measuring Bipolar I Disorder, Medical Risks, Integrated Risk Reduction Intervention, Currently in Remission, BMI

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Western Psychiatric Institute and Clinic, University of Pittsburgh Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

IRRI

PCCM

Arm Description

The integrated risk reduction intervention (IRRI) consists of three components: psychiatric treatment by a study psychiatrist assessment, referral, monitoring, and coordination by a certified registered nurse practitioner (CRNP) of medical treatment provided by the subject's own primary care physician 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.

Psychiatric Care with Medical Monitoring (PCMM) The psychiatric care with medical monitoring condition (PCMM) consists of two components: psychiatric treatment by a study psychiatrist 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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
September 3, 2008
Last Updated
December 11, 2013
Sponsor
University of Pittsburgh
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00746343
Brief Title
Reducing Medical Risks in Individuals With Bipolar Disorder - Full Study
Acronym
MedRisk
Official Title
Reducing Medical Risks in Individuals With Bipolar Disorder - Full Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pittsburgh
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar I Disorder
Keywords
Bipolar I Disorder, Medical Risks, Integrated Risk Reduction Intervention, Currently in Remission, BMI

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
122 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IRRI
Arm Type
Experimental
Arm Description
The integrated risk reduction intervention (IRRI) consists of three components: psychiatric treatment by a study psychiatrist assessment, referral, monitoring, and coordination by a certified registered nurse practitioner (CRNP) of medical treatment provided by the subject's own primary care physician 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.
Arm Title
PCCM
Arm Type
Experimental
Arm Description
Psychiatric Care with Medical Monitoring (PCMM) The psychiatric care with medical monitoring condition (PCMM) consists of two components: psychiatric treatment by a study psychiatrist 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.
Intervention Type
Behavioral
Intervention Name(s)
IRRI
Other Intervention Name(s)
Integrated Risk Reduction Intervention
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
PCCM
Other Intervention Name(s)
Psychiatric care with medical monitoring condition
Intervention Description
Subjects will remain in their assigned treatment condition for 24 months.
Primary Outcome Measure Information:
Title
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
Title
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
Secondary Outcome Measure Information:
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18 to 55 years Body mass index (BMI) >25 Meets DSM-IV criteria for lifetime bipolar I disorder 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 Able to give basic informed consent 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: Ultra-rapid cycling (>8 episodes per year) bipolar I disorder Presence of pervasive developmental disorder, antisocial personality disorder, current substance dependence or abuse, and organic mental disorder 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 Unwilling or unable to comply with study requirements (i.e., complete forms, attend scheduled evaluations) Not competent to provide informed consent in the opinion of the investigator Women who are planning to become pregnant, currently pregnant, or breast-feeding
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David J Kupfer, M.D.
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
Western Psychiatric Institute and Clinic, University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States

12. IPD Sharing Statement

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