search
Back to results

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
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depression

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All Sexes

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

    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
    search

    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

    We'll reach out to this number within 24 hrs