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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01561105
Other study ID # JAHF 98297
Secondary ID
Status Completed
Phase N/A
First received March 20, 2012
Last updated March 26, 2012
Start date January 1999
Est. completion date June 2004

Study information

Verified date March 2012
Source University of California, Los Angeles
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

Purpose: To determine the effectiveness of the Improving Mood-Promoting Access to Collaborative Treatment(IMPACT) collaborative care management program for late-life depression.


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.


Recruitment information / eligibility

Status Completed
Enrollment 1801
Est. completion date June 2004
Est. primary completion date June 2004
Accepts healthy volunteers
Gender Both
Age group 60 Years and older
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
IMPACT
IMPACT is a collaborative care management program for late-life depression

Locations

Country Name City State
n/a

Sponsors (5)

Lead Sponsor Collaborator
University of California, Los Angeles California HealthCare Foundation, Hogg Foundation, Robert Wood Johnson Foundation, The John A. Hartford Foundation

References & Publications (1)

Unützer J, Katon W, Callahan CM, Williams JW Jr, Hunkeler E, Harpole L, Hoffing M, Della Penna RD, Noël PH, Lin EH, Areán PA, Hegel MT, Tang L, Belin TR, Oishi S, Langston C; IMPACT Investigators. Improving Mood-Promoting Access to Collaborative Treatment — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Severity of depression symptoms Severity measured by the 21-item Hopkins Symptom Checklist. No
Secondary Functioning measured by the Sheehan Health-Related Functioning Index No
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