Reducing Medical Risks in Individuals With Bipolar Disorder - Full Study

NCT00746343 | Completed

• 2 other identifiers: PRO08020071R01MH081003
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

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.

Conditions

Bipolar I Disorder

Keywords

Bipolar I Disorder; Medical Risks; Integrated Risk Reduction Intervention; Currently in Remission; BMI

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• 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

Study Arms (2)

IRRI

EXPERIMENTAL

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

PCCM

EXPERIMENTAL

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

Interventions

IRRI BEHAVIORAL

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.

Also known as: Integrated Risk Reduction Intervention

IRRI

PCCM BEHAVIORAL

Subjects will remain in their assigned treatment condition for 24 months.

Also known as: Psychiatric care with medical monitoring condition

PCCM

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Western Psychiatric Institute and Clinic, University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Study Officials

• David J Kupfer, M.D.

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2008
• First Posted: September 4, 2008
• Study Start: September 1, 2008
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: December 12, 2013

Record last verified: 2013-12

Locations

US (1)