Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00007761
Status:
COMPLETED
Last Update Posted:
2009-09-24
First Post:
2000-12-29
Brief Title:
Does Bipolar Disease Program BDP Intervention Improve Long Term Manic and Depressive Symptoms
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
CSP 430 - Reducing The Efficacy-Effectiveness Gap In Bipolar Disorder
Status:
COMPLETED
Status Verified Date:
2009-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None