Improving Depression Care for Elders: Coordinating Center (IMPACT)
Primary Purpose
Major Depression, Dysthymic Disorder, Both Major Depression and Dysthymic Disorder
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
IMPACT
Sponsored by
About this trial
This is an interventional treatment trial for Major Depression
Eligibility Criteria
Inclusion Criteria:
- Major depression or dysthymia as diagnosed by a structured diagnostic interview.
- Patient plans to receive primary care at the study clinic for the next year.
Exclusion Criteria:
- Age under 60.
- Current symptoms or history of psychosis or mania as determined by structured diagnostic interview.
- Cognitive impairment as defined by a score less than 23 on a Mini Mental Status Examination.
- Terminal illness - defined as having a life expectancy of less than 6 months.
- Active alcohol abuse as determined by a screening interview.
- High suicide risk as determined by current plan for suicide or a history of more than 3 prior suicide attempts in the past 10 years.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
IMPACT
Care as Usual
Arm Description
Patients received all depression care available to them as part of care as usual in the participating primary care clinics.
Outcomes
Primary Outcome Measures
Severity of depression symptoms
Severity measured by the 21-item Hopkins Symptom Checklist.
Secondary Outcome Measures
Functioning
measured by the Sheehan Health-Related Functioning Index
Full Information
NCT ID
NCT01561105
First Posted
March 20, 2012
Last Updated
March 26, 2012
Sponsor
University of California, Los Angeles
Collaborators
The John A. Hartford Foundation, California HealthCare Foundation, Hogg Foundation, Robert Wood Johnson Foundation
1. Study Identification
Unique Protocol Identification Number
NCT01561105
Brief Title
Improving Depression Care for Elders: Coordinating Center
Acronym
IMPACT
Official Title
This Was a Five-year Seven-site Trial to Study the Cost-effectiveness of a Population Based Disease Management Program for Late Life Depression in Primary Care.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
January 1999 (undefined)
Primary Completion Date
June 2004 (Actual)
Study Completion Date
June 2004 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles
Collaborators
The John A. Hartford Foundation, California HealthCare Foundation, Hogg Foundation, Robert Wood Johnson Foundation
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Purpose: To determine the effectiveness of the Improving Mood-Promoting Access to Collaborative Treatment(IMPACT) collaborative care management program for late-life depression.
Detailed Description
This study tested an organized method of delivering care for late life depression in primary care. Specifically, the investigators evaluated the effectiveness of this intervention as compared to 'care as usual'. The investigators studied the effect of the intervention on clinical outcomes such as depressive symptoms, functional status, health related quality of life. They also determined the cost-effectiveness of the intervention compared to care as usual.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depression, Dysthymic Disorder, Both Major Depression and Dysthymic Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
1801 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IMPACT
Arm Type
Experimental
Arm Title
Care as Usual
Arm Type
No Intervention
Arm Description
Patients received all depression care available to them as part of care as usual in the participating primary care clinics.
Intervention Type
Other
Intervention Name(s)
IMPACT
Other Intervention Name(s)
Improving Mood-Promoting Access to Collaborative Treatment
Intervention Description
IMPACT is a collaborative care management program for late-life depression
Primary Outcome Measure Information:
Title
Severity of depression symptoms
Description
Severity measured by the 21-item Hopkins Symptom Checklist.
Secondary Outcome Measure Information:
Title
Functioning
Description
measured by the Sheehan Health-Related Functioning Index
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Eligibility Criteria
Inclusion Criteria:
Major depression or dysthymia as diagnosed by a structured diagnostic interview.
Patient plans to receive primary care at the study clinic for the next year.
Exclusion Criteria:
Age under 60.
Current symptoms or history of psychosis or mania as determined by structured diagnostic interview.
Cognitive impairment as defined by a score less than 23 on a Mini Mental Status Examination.
Terminal illness - defined as having a life expectancy of less than 6 months.
Active alcohol abuse as determined by a screening interview.
High suicide risk as determined by current plan for suicide or a history of more than 3 prior suicide attempts in the past 10 years.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jurgen Unutzer, MD, MPH
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
12472325
Citation
Unutzer J, Katon W, Callahan CM, Williams JW Jr, Hunkeler E, Harpole L, Hoffing M, Della Penna RD, Noel PH, Lin EH, Arean PA, Hegel MT, Tang L, Belin TR, Oishi S, Langston C; IMPACT Investigators. Improving Mood-Promoting Access to Collaborative Treatment. Collaborative care management of late-life depression in the primary care setting: a randomized controlled trial. JAMA. 2002 Dec 11;288(22):2836-45. doi: 10.1001/jama.288.22.2836.
Results Reference
result
PubMed Identifier
24367124
Citation
Stewart JC, Perkins AJ, Callahan CM. Effect of collaborative care for depression on risk of cardiovascular events: data from the IMPACT randomized controlled trial. Psychosom Med. 2014 Jan;76(1):29-37. doi: 10.1097/PSY.0000000000000022. Epub 2013 Dec 23.
Results Reference
derived
Learn more about this trial
Improving Depression Care for Elders: Coordinating Center
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