Ignite Creation Date:
2025-12-24 @ 12:23 PM
Ignite Modification Date:
2025-12-27 @ 9:29 PM
Study NCT ID:
NCT00007761
Status:
COMPLETED
Last Update Posted:
2009-09-24
First Post:
2000-12-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Does Bipolar Disease Program (BDP) Intervention Improve Long Term Manic and Depressive Symptoms.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001714', 'term': 'Bipolar Disorder'}], 'ancestors': [{'id': 'D000068105', 'term': 'Bipolar and Related Disorders'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011570', 'term': 'Psychiatry'}], 'ancestors': [{'id': 'D001525', 'term': 'Behavioral Sciences'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 382}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1997-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-09', 'lastUpdateSubmitDate': '2009-09-22', 'studyFirstSubmitDate': '2000-12-29', 'studyFirstSubmitQcDate': '2000-12-30', 'lastUpdatePostDateStruct': {'date': '2009-09-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2001-01-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2003-12', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Bipolar Disease Program intervention'], 'conditions': ['Bipolar Disorder']}, 'referencesModule': {'references': [{'pmid': '18930558', 'type': 'RESULT', '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. 2009 Jun;115(3):355-9. doi: 10.1016/j.jad.2008.09.020. Epub 2008 Oct 18.'}, {'pmid': '16213029', 'type': 'RESULT', '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. doi: 10.1016/j.jad.2005.06.012. Epub 2005 Oct 4.'}, {'pmid': '15977942', 'type': 'RESULT', '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. doi: 10.2190/U1D5-8B1D-UW69-U1Y4.'}, {'pmid': '15780700', 'type': 'RESULT', '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. doi: 10.1016/j.jad.2004.11.009.'}, {'pmid': '14702242', 'type': 'RESULT', 'citation': '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': '14525558', 'type': 'RESULT', '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. doi: 10.1034/j.1399-5618.2003.00043.x.'}, {'pmid': '12397882', 'type': 'RESULT', 'citation': 'Bauer MS. An evidence-based review of psychosocial treatments for bipolar disorder. Psychopharmacol Bull. 2001 Summer;35(3):109-34.'}, {'pmid': '12023929', 'type': 'RESULT', '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. doi: 10.1080/10673220216217.'}, {'pmid': '11903206', 'type': 'RESULT', '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. doi: 10.1034/j.1399-5618.2001.30502.x.'}, {'pmid': '11511403', 'type': 'RESULT', '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. doi: 10.1016/s0165-0327(00)00247-0.'}, {'pmid': '11349236', 'type': 'RESULT', '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. doi: 10.1053/comp.2001.23143.'}, {'pmid': '11252648', 'type': 'RESULT', '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. doi: 10.1034/j.1399-5618.2000.020409.x.'}, {'pmid': '18586992', 'type': 'RESULT', '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. doi: 10.1176/ps.2008.59.7.753.'}, {'pmid': '17978254', 'type': 'RESULT', '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. doi: 10.1176/ps.2007.58.11.1441.'}, {'pmid': '16816277', 'type': 'RESULT', '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. doi: 10.1176/ps.2006.57.7.937.'}, {'pmid': '16816276', 'type': 'RESULT', '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. doi: 10.1176/ps.2006.57.7.927.'}, {'pmid': '16399963', 'type': 'RESULT', '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. doi: 10.1176/appi.ps.57.1.56.'}, {'pmid': '15820270', 'type': 'RESULT', '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. doi: 10.1016/j.jad.2004.12.006.'}, {'pmid': '15654937', 'type': 'RESULT', '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. doi: 10.1111/j.1399-5618.2004.00161.x.'}, {'pmid': '15541060', 'type': 'RESULT', '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. doi: 10.1111/j.1399-5618.2004.00159.x."}, {'pmid': '11874218', 'type': 'RESULT', '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. doi: 10.4088/jcp.v63n0212.'}, {'pmid': '11869753', 'type': 'RESULT', '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. doi: 10.1016/s0165-0327(01)00440-2."}, {'pmid': '18504059', 'type': 'RESULT', '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. doi: 10.1016/j.jad.2008.04.010. Epub 2008 May 27.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nSecondary 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.\n\nIntervention: Usual (psychiatric) Care vs Bipolar Disorder Program\n\nPrimary Outcomes: The primary outcomes are: (1) Manic Symptom Score; (2) Depressive Symptom Score; and (3) Total Treatment Costs.\n\nStudy 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.\n\nPatients 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients 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.\n\nExclusion Criteria:'}, 'identificationModule': {'nctId': 'NCT00007761', 'briefTitle': 'Does Bipolar Disease Program (BDP) Intervention Improve Long Term Manic and Depressive Symptoms.', 'organization': {'class': 'FED', 'fullName': 'VA Office of Research and Development'}, 'officialTitle': 'CSP #430 - Reducing The Efficacy-Effectiveness Gap In Bipolar Disorder', 'orgStudyIdInfo': {'id': '430'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Bipolar Disorder Program', 'interventionNames': ['Behavioral: Bipolar Disorder Program']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Usual (psychiatric) Care', 'interventionNames': ['Behavioral: Usual (psychiatric) Care']}], 'interventions': [{'name': 'Bipolar Disorder Program', 'type': 'BEHAVIORAL', 'armGroupLabels': ['1']}, {'name': 'Usual (psychiatric) Care', 'type': 'BEHAVIORAL', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85723', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Southern Arizona VA Health Care System, Tucson', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '94304-1290', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'VA Palo Alto Health Care System', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '92161', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'VA San Diego Healthcare System, San Diego', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '90073', 'city': 'West Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'VA Greater Los Angeles Healthcare System, West LA', 'geoPoint': {'lat': 34.0462, 'lon': -118.43068}}, {'zip': '80220', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'VA Eastern Colorado Health Care System, Denver', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '06516', 'city': 'West Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'VA Connecticut Health Care System (West Haven)', 'geoPoint': {'lat': 41.27065, 'lon': -72.94705}}, {'zip': '30904', 'city': 'Augusta', 'state': 'Georgia', 'country': 'United States', 'facility': 'VA Medical Center, Augusta', 'geoPoint': {'lat': 33.47097, 'lon': -81.97484}}, {'zip': '60141-5000', 'city': 'Hines', 'state': 'Illinois', 'country': 'United States', 'facility': 'Edward Hines, Jr. VA Hospital', 'geoPoint': {'lat': 41.85364, 'lon': -87.8395}}, {'zip': '46202-2884', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Richard Roudebush VA Medical Center, Indianapolis', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '02301', 'city': 'Brockton', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'VA Boston Healthcare System, Brockton Campus', 'geoPoint': {'lat': 42.08343, 'lon': -71.01838}}, {'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'VA Medical Center, Cleveland', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '37684', 'city': 'Mountain Home', 'state': 'Tennessee', 'country': 'United States', 'facility': 'James H. Quillen VA Medical Center', 'geoPoint': {'lat': 36.31066, 'lon': -82.3732}}, {'zip': '75216', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'VA North Texas Health Care System, Dallas', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'overallOfficials': [{'name': 'Mark S Bauer, MD BA', 'role': 'STUDY_CHAIR', 'affiliation': 'VA Boston Healthcare System, Brockton Campus'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'US Department of Veterans Affairs', 'class': 'FED'}, 'responsibleParty': {'oldNameTitle': 'Bauer, Mark - Study Chair', 'oldOrganization': 'Department of Veterans Affairs'}}}}