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

This study has been completed.
Sponsor:
Information provided by:
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00007761
First received: December 29, 2000
Last updated: September 22, 2009
Last verified: September 2009
  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.


Condition Intervention Phase
Bipolar Disorder
Behavioral: Bipolar Disorder Program
Behavioral: Usual (psychiatric) Care
Phase 3

Study Type: Interventional
Official Title: CSP #430 - Reducing The Efficacy-Effectiveness Gap In Bipolar Disorder

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Estimated Enrollment: 382
Study Start Date: July 1997
Primary Completion Date: December 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Bipolar Disorder Program
Behavioral: Bipolar Disorder Program
Active Comparator: 2
Usual (psychiatric) Care
Behavioral: Usual (psychiatric) Care

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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:

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00007761

Locations
United States, Arizona
Southern Arizona VA Health Care System, Tucson
Tucson, Arizona, United States, 85723
United States, California
VA Palo Alto Health Care System
Palo Alto, California, United States, 94304-1290
VA San Diego Healthcare System, San Diego
San Diego, California, United States, 92161
VA Greater Los Angeles Healthcare System, West LA
West Los Angeles, California, United States, 90073
United States, Colorado
VA Eastern Colorado Health Care System, Denver
Denver, Colorado, United States, 80220
United States, Connecticut
VA Connecticut Health Care System (West Haven)
West Haven, Connecticut, United States, 06516
United States, Georgia
VA Medical Center, Augusta
Augusta, Georgia, United States, 30904
United States, Illinois
Edward Hines, Jr. VA Hospital
Hines, Illinois, United States, 60141-5000
United States, Indiana
Richard Roudebush VA Medical Center, Indianapolis
Indianapolis, Indiana, United States, 46202-2884
United States, Massachusetts
VA Boston Healthcare System, Brockton Campus
Brockton, Massachusetts, United States, 02301
United States, Ohio
VA Medical Center, Cleveland
Cleveland, Ohio, United States, 44106
United States, Tennessee
James H. Quillen VA Medical Center
Mountain Home, Tennessee, United States, 37684
United States, Texas
VA North Texas Health Care System, Dallas
Dallas, Texas, United States, 75216
Sponsors and Collaborators
Investigators
Study Chair: Mark S Bauer, MD BA VA Boston Healthcare System, Brockton Campus
  More Information

Publications:

Responsible Party: Bauer, Mark - Study Chair, Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00007761     History of Changes
Other Study ID Numbers: 430
Study First Received: December 29, 2000
Last Updated: September 22, 2009
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Bipolar Disease Program intervention

Additional relevant MeSH terms:
Disease
Bipolar Disorder
Pathologic Processes
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 18, 2014