NCT00007761

Brief Summary

Based on highly promising preliminary data, it is proposed to conduct a multi-site randomized controlled trial of a high-intensity ambulatory treatment program for bipolar disorder against standard office-based, physician-centered care. The major characteristics of this program are that it emphasizes (1) aggressive guideline-driven pharmacotherapy, (2) continuity of care with identified primary mental health nurse clinicians supported by psychiatrist back-up, and (3) patient education to improve treatment alliance and illness management skills.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
382

participants targeted

Target at P50-P75 for phase_3

Geographic Reach
1 country

13 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 1997

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

December 29, 2000

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 1, 2001

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2003

Completed
Last Updated

September 24, 2009

Status Verified

September 1, 2009

Enrollment Period

6.4 years

First QC Date

December 29, 2000

Last Update Submit

September 22, 2009

Conditions

Bipolar Disorder

Keywords

Bipolar Disease Program intervention

Study Arms (2)

1

EXPERIMENTAL

Bipolar Disorder Program

Behavioral: Bipolar Disorder Program

2

ACTIVE COMPARATOR

Usual (psychiatric) Care

Behavioral: Usual (psychiatric) Care

Interventions

Bipolar Disorder ProgramBEHAVIORAL
1
Usual (psychiatric) CareBEHAVIORAL
2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with bipolar disorder. Index episode of manic, major depression or both requiring hospitalization on acute unit. At lease two hospitalizations, three or more months apart within the past 5 years.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Southern Arizona VA Health Care System, Tucson

Tucson, Arizona, 85723, United States

Location

VA Palo Alto Health Care System

Palo Alto, California, 94304-1290, United States

Location

VA San Diego Healthcare System, San Diego

San Diego, California, 92161, United States

Location

VA Greater Los Angeles Healthcare System, West LA

West Los Angeles, California, 90073, United States

Location

VA Eastern Colorado Health Care System, Denver

Denver, Colorado, 80220, United States

Location

VA Connecticut Health Care System (West Haven)

West Haven, Connecticut, 06516, United States

Location

VA Medical Center, Augusta

Augusta, Georgia, 30904, United States

Location

Edward Hines, Jr. VA Hospital

Hines, Illinois, 60141-5000, United States

Location

Richard Roudebush VA Medical Center, Indianapolis

Indianapolis, Indiana, 46202-2884, United States

Location

VA Boston Healthcare System, Brockton Campus

Brockton, Massachusetts, 02301, United States

Location

VA Medical Center, Cleveland

Cleveland, Ohio, 44106, United States

Location

James H. Quillen VA Medical Center

Mountain Home, Tennessee, 37684, United States

Location

VA North Texas Health Care System, Dallas

Dallas, Texas, 75216, United States

Location

Related Publications (23)

  • Pirraglia PA, Biswas K, Kilbourne AM, Fenn H, Bauer MS. A prospective study of the impact of comorbid medical disease on bipolar disorder outcomes. J Affect Disord. 2009 Jun;115(3):355-9. doi: 10.1016/j.jad.2008.09.020. Epub 2008 Oct 18.

    PMID: 18930558RESULT

  • Brown GR, McBride L, Bauer MS, Williford WO; Cooperative Studies Program 430 Study Team. Impact of childhood abuse on the course of bipolar disorder: a replication study in U.S. veterans. J Affect Disord. 2005 Dec;89(1-3):57-67. doi: 10.1016/j.jad.2005.06.012. Epub 2005 Oct 4.

    PMID: 16213029RESULT

  • Bauer MS, Williford WO, McBride L, McBride K, Shea NM. Perceived barriers to health care access in a treated population. Int J Psychiatry Med. 2005;35(1):13-26. doi: 10.2190/U1D5-8B1D-UW69-U1Y4.

    PMID: 15977942RESULT

  • Bauer MS, Altshuler L, Evans DR, Beresford T, Williford WO, Hauger R; VA Cooperative Study #430 Team. Prevalence and distinct correlates of anxiety, substance, and combined comorbidity in a multi-site public sector sample with bipolar disorder. J Affect Disord. 2005 Apr;85(3):301-15. doi: 10.1016/j.jad.2004.11.009.

    PMID: 15780700RESULT

  • Bauer MS, Mitchner L. What is a "mood stabilizer"? An evidence-based response. Am J Psychiatry. 2004 Jan;161(1):3-18. doi: 10.1176/appi.ajp.161.1.3.

    PMID: 14702242RESULT

  • Glick HA, McBride L, Bauer MS. A manic-depressive symptom self-report in optical scanable format. Bipolar Disord. 2003 Oct;5(5):366-9. doi: 10.1034/j.1399-5618.2003.00043.x.

    PMID: 14525558RESULT

  • Bauer MS. An evidence-based review of psychosocial treatments for bipolar disorder. Psychopharmacol Bull. 2001 Summer;35(3):109-34.

    PMID: 12397882RESULT

  • Bauer MS. A review of quantitative studies of adherence to mental health clinical practice guidelines. Harv Rev Psychiatry. 2002 May-Jun;10(3):138-53. doi: 10.1080/10673220216217.

    PMID: 12023929RESULT

  • Bauer MS. The collaborative practice model for bipolar disorder: design and implementation in a multi-site randomized controlled trial. Bipolar Disord. 2001 Oct;3(5):233-44. doi: 10.1034/j.1399-5618.2001.30502.x.

    PMID: 11903206RESULT

  • Bauer MS, Kirk GF, Gavin C, Williford WO. Determinants of functional outcome and healthcare costs in bipolar disorder: a high-intensity follow-up study. J Affect Disord. 2001 Aug;65(3):231-41. doi: 10.1016/s0165-0327(00)00247-0.

    PMID: 11511403RESULT

  • Vojta C, Kinosian B, Glick H, Altshuler L, Bauer MS. Self-reported quality of life across mood states in bipolar disorder. Compr Psychiatry. 2001 May-Jun;42(3):190-5. doi: 10.1053/comp.2001.23143.

    PMID: 11349236RESULT

  • Bauer MS, Vojta C, Kinosian B, Altshuler L, Glick H. The Internal State Scale: replication of its discriminating abilities in a multisite, public sector sample. Bipolar Disord. 2000 Dec;2(4):340-6. doi: 10.1034/j.1399-5618.2000.020409.x.

    PMID: 11252648RESULT

  • Sajatovic M, Biswas K, Kilbourne AK, Fenn H, Williford W, Bauer MS. Factors associated with prospective long-term treatment adherence among individuals with bipolar disorder. Psychiatr Serv. 2008 Jul;59(7):753-9. doi: 10.1176/ps.2008.59.7.753.

    PMID: 18586992RESULT

  • Altshuler L, Tekell J, Biswas K, Kilbourne AM, Evans D, Tang D, Bauer MS. Executive function and employment status among veterans with bipolar disorder. Psychiatr Serv. 2007 Nov;58(11):1441-7. doi: 10.1176/ps.2007.58.11.1441.

    PMID: 17978254RESULT

  • Bauer MS, McBride L, Williford WO, Glick H, Kinosian B, Altshuler L, Beresford T, Kilbourne AM, Sajatovic M; Cooperative Studies Program 430 Study Team. Collaborative care for bipolar disorder: Part II. Impact on clinical outcome, function, and costs. Psychiatr Serv. 2006 Jul;57(7):937-45. doi: 10.1176/ps.2006.57.7.937.

    PMID: 16816277RESULT

  • Bauer MS, McBride L, Williford WO, Glick H, Kinosian B, Altshuler L, Beresford T, Kilbourne AM, Sajatovic M; Cooperative Studies Program 430 Study Team. Collaborative care for bipolar disorder: part I. Intervention and implementation in a randomized effectiveness trial. Psychiatr Serv. 2006 Jul;57(7):927-36. doi: 10.1176/ps.2006.57.7.927.

    PMID: 16816276RESULT

  • Sajatovic M, Bauer MS, Kilbourne AM, Vertrees JE, Williford W. Self-reported medication treatment adherence among veterans with bipolar disorder. Psychiatr Serv. 2006 Jan;57(1):56-62. doi: 10.1176/appi.ps.57.1.56.

    PMID: 16399963RESULT

  • Fenn HH, Bauer MS, Altshuler L, Evans DR, Williford WO, Kilbourne AM, Beresford TP, Kirk G, Stedman M, Fiore L; VA Cooperative Study #430 Team. Medical comorbidity and health-related quality of life in bipolar disorder across the adult age span. J Affect Disord. 2005 May;86(1):47-60. doi: 10.1016/j.jad.2004.12.006.

    PMID: 15820270RESULT

  • Kilbourne AM, Bauer MS, Pincus H, Williford WO, Kirk GF, Beresford T; Veterans Administration (VA) Cooperative Study #430 Team. Clinical, psychosocial, and treatment differences in minority patients with bipolar disorder. Bipolar Disord. 2005 Feb;7(1):89-97. doi: 10.1111/j.1399-5618.2004.00161.x.

    PMID: 15654937RESULT

  • Glick HA, Kinosian B, McBride L, Williford WO, Bauer MS; CSP #430 Study Team. Clinical nurse specialist care managers' time commitments in a disease-management program for bipolar disorder. Bipolar Disord. 2004 Dec;6(6):452-9. doi: 10.1111/j.1399-5618.2004.00159.x.

    PMID: 15541060RESULT

  • Polsky D, Onesirosan P, Bauer MS, Glick HA. Duration of therapy and health care costs of fluoxetine, paroxetine, and sertraline in 6 health plans. J Clin Psychiatry. 2002 Feb;63(2):156-64. doi: 10.4088/jcp.v63n0212.

    PMID: 11874218RESULT

  • Bauer MS, Williford WO, Dawson EE, Akiskal HS, Altshuler L, Fye C, Gelenberg A, Glick H, Kinosian B, Sajatovic M. Principles of effectiveness trials and their implementation in VA Cooperative Study #430: 'Reducing the efficacy-effectiveness gap in bipolar disorder'. J Affect Disord. 2001 Dec;67(1-3):61-78. doi: 10.1016/s0165-0327(01)00440-2.

    PMID: 11869753RESULT

  • Kilbourne AM, Biswas K, Pirraglia PA, Sajatovic M, Williford WO, Bauer MS. Is the collaborative chronic care model effective for patients with bipolar disorder and co-occurring conditions? J Affect Disord. 2009 Jan;112(1-3):256-61. doi: 10.1016/j.jad.2008.04.010. Epub 2008 May 27.

    PMID: 18504059RESULT

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Psychiatry

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Behavioral SciencesBehavioral Disciplines and Activities

Study Officials

  • Mark S Bauer, MD BA

    VA Boston Healthcare System, Brockton Campus

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Sponsor Type
FED

Study Record Dates

First Submitted

December 29, 2000

First Posted

January 1, 2001

Study Start

July 1, 1997

Primary Completion

December 1, 2003

Last Updated

September 24, 2009

Record last verified: 2009-09

Locations

US(13)