West Haven, Connecticut 06516

  • Bipolar Disorder

Purpose:

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.


Study summary:

Primary Hypothesis: The primary hypotheses are that Bipolar Disease Program (BDP) intervention will significantly improve (1) manic and (2) depressive symptom scores, as well as Total Treatment Costs as compared to usual care of bipolar patients. Secondary Hypothesis: Secondary hypotheses include significant improvement in BDP patients as compared to usual bipolar treatment care with respect to functional outcome, quality of life, intensity of somatotherapy, patient satisfaction, and provider attitudes. Intervention: Usual (psychiatric) Care vs Bipolar Disorder Program Primary Outcomes: The primary outcomes are: (1) Manic Symptom Score; (2) Depressive Symptom Score; and (3) Total Treatment Costs. Study Abstract: 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. Patients with bipolar disorder will be randomly assigned to either standard care or the high intensity ambulatory program for three years. Outcome variables will cover three distinct domains: disease-specific outcome (number, length, and severity of manic and depressive episodes), functional outcome (social and occupational role function and subjective quality of life), and total treatment costs (direct treatment costs and indirect costs of illness). Preliminary data indicate that these domains are related but not redundant. Each of these is relevant to patient well-being and to VHA management.


Criteria:

Inclusion Criteria: 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. Exclusion Criteria:


Study is Available At:


Original ID:

430


NCT ID:

NCT00007761


Secondary ID:


Study Acronym:


Brief Title:

Does Bipolar Disease Program (BDP) Intervention Improve Long Term Manic and Depressive Symptoms.


Official Title:

CSP #430 - Reducing The Efficacy-Effectiveness Gap In Bipolar Disorder


Overall Status:

Completed


Study Phase:

Phase 3


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Department of Veterans Affairs


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

N/A


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

382


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Mark S Bauer, MD BA
Study Chair
VA Boston Healthcare System, Brockton Campus

Study Dates

Start Date:July 1997
Primary Completion Date:December 2003
Primary Completion Type:Actual
Verification Date:September 2009
Last Changed Date:September 22, 2009
First Received Date:December 29, 2000

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Behavioral
Name:Usual (psychiatric) Care
Arm Name:2
Intervention Type:Behavioral
Name:Bipolar Disorder Program
Arm Name:1

Study Arms

Study Arm Type:Active Comparator
Arm Name:2
Description:Usual (psychiatric) Care
Study Arm Type:Experimental
Arm Name:1
Description:Bipolar Disorder Program

Study Agencies

Agency Class:U.S. Fed
Agency Type:Lead Sponsor
Agency Name:Department of Veterans Affairs

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Results Reference
Citation: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. 2008 Oct 17; [Epub ahead of print]
PMID:18930558
Reference Type:Results Reference
Citation: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. Epub 2005 Oct 4.
PMID:16213029
Reference Type:Results Reference
Citation: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.
PMID:15977942
Reference Type:Results Reference
Citation: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.
PMID:15780700
Reference Type:Results Reference
Citation:Bauer MS, Mitchner L. What is a "mood stabilizer"? An evidence-based response. Am J Psychiatry. 2004 Jan;161(1):3-18. Review.
PMID:14702242
Reference Type:Results Reference
Citation:Glick HA, McBride L, Bauer MS. A manic-depressive symptom self-report in optical scanable format. Bipolar Disord. 2003 Oct;5(5):366-9.
PMID:14525558
Reference Type:Results Reference
Citation:Bauer MS. An evidence-based review of psychosocial treatments for bipolar disorder. Psychopharmacol Bull. 2001 Summer;35(3):109-34. Review.
PMID:12397882
Reference Type:Results Reference
Citation: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. Review.
PMID:12023929
Reference Type:Results Reference
Citation: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.
PMID:11903206
Reference Type:Results Reference
Citation: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.
PMID:11511403
Reference Type:Results Reference
Citation: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.
PMID:11349236
Reference Type:Results Reference
Citation: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.
PMID:11252648
Reference Type:Results Reference
Citation: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.
PMID:18586992
Reference Type:Results Reference
Citation: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.
PMID:17978254
Reference Type:Results Reference
Citation: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.
PMID:16816277
Reference Type:Results Reference
Citation: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.
PMID:16816276
Reference Type:Results Reference
Citation: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.
PMID:16399963
Reference Type:Results Reference
Citation: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. Erratum in: J Affect Disord. 2006 Feb;90(2-3):275. Alshuler, Lori [corrected to Altshuler, Lori].
PMID:15820270
Reference Type:Results Reference
Citation: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.
PMID:15654937
Reference Type:Results Reference
Citation: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.
PMID:15541060
Reference Type:Results Reference
Citation: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.
PMID:11874218
Reference Type:Results Reference
Citation: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.
PMID:11869753
Reference Type:Results Reference
Citation: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. Epub 2008 May 27.
PMID:18504059

Data Source: ClinicalTrials.gov

Date Processed: September 23, 2021

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