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

December 11, 2013 updated by: University of Pittsburgh
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 Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

122

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • Western Psychiatric Institute and Clinic, University of Pittsburgh Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.
Other Names:
  • Integrated Risk Reduction Intervention
Experimental: 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.
Behavioral: PCCM
Subjects will remain in their assigned treatment condition for 24 months.
Other Names:
  • Psychiatric care with medical monitoring condition

What is the study measuring?

Primary Outcome Measures

Outcome 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.
Time Frame: Entry and every 6 months of participation for two years
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.
Time Frame: Entry and every 6 months of participation for two years
Entry and every 6 months of participation for two years

Secondary Outcome Measures

Outcome 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.
Time Frame: 6, 12, and 18 month timepoints of participation
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.
Time Frame: This is assessed by how many missed appointments the subject has for IRRI
This is assessed by how many missed appointments the subject has for IRRI

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pittsburgh

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: David J Kupfer, M.D., University of Pittsburgh

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

September 1, 2013

Study Registration Dates

First Submitted

September 3, 2008

First Submitted That Met QC Criteria

September 3, 2008

First Posted (Estimate)

September 4, 2008

Study Record Updates

Last Update Posted (Estimate)

December 12, 2013

Last Update Submitted That Met QC Criteria

December 11, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRO08020071
  • R01MH081003 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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