- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01561105
Improving Depression Care for Elders: Coordinating Center (IMPACT)
March 26, 2012 updated by: Jurgen Unutzer, MD, MPH, University of California, Los Angeles
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.
Purpose: To determine the effectiveness of the Improving Mood-Promoting Access to Collaborative Treatment(IMPACT) collaborative care management program for late-life depression.
Study Overview
Status
Completed
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
1801
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: IMPACT
|
IMPACT is a collaborative care management program for late-life depression
Other Names:
|
No Intervention: Care as Usual
Patients received all depression care available to them as part of care as usual in the participating primary care clinics.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
---|---|
Severity of depression symptoms
|
Severity measured by the 21-item Hopkins Symptom Checklist.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
---|---|
Functioning
|
measured by the Sheehan Health-Related Functioning Index
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Jurgen Unutzer, MD, MPH, University of Washington
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 1999
Primary Completion (Actual)
June 1, 2004
Study Completion (Actual)
June 1, 2004
Study Registration Dates
First Submitted
March 20, 2012
First Submitted That Met QC Criteria
March 20, 2012
First Posted (Estimate)
March 22, 2012
Study Record Updates
Last Update Posted (Estimate)
March 28, 2012
Last Update Submitted That Met QC Criteria
March 26, 2012
Last Verified
March 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- JAHF 98297
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Major Depression
-
Stanford UniversityTerminatedMajor Depressive Disorder | Major Depressive Episode | Major Depressive Disorder, Recurrent | Major Depression Mild | Major Depression Moderate | Major Depression SevereUnited States
-
Hawler Medical UniversityCompleted
-
Centre Hospitalier Universitaire de BesanconH. Lundbeck A/SCompletedResistant Major DepressionFrance
-
First Affiliated Hospital of Zhejiang UniversityNot yet recruiting
-
University of PittsburghCompletedPostpartum Major DepressionUnited States
-
Si TianmeiUnknownMajor Depression DisorderChina
-
The Hong Kong Polytechnic UniversityNot yet recruitingHealthy | Major Depression in Remission
-
AstraZenecaCompletedNon-psychotic Unipolar Major DepressionArgentina
-
Ruijin HospitalTerminatedTreatment Resistant Major Depression DisorderChina
-
Zentrum für Integrative PsychiatrieGerman Research FoundationCompletedCognitive Performance in Major DepressionGermany
Clinical Trials on IMPACT
-
Centre Hospitalier Universitaire de NiceNovartisCompleted
-
Vanderbilt UniversityNational Institute on Deafness and Other Communication Disorders (NIDCD)CompletedAutism Spectrum DisorderUnited States
-
University Hospital, Clermont-FerrandCentre Leon Berard; Novartis; Centre Hospitalier Universitaire de Saint Etienne; Institut de Cancérologie de la Loire and other collaboratorsCompletedHead and Neck Cancer | Malnutrition | Esophageal CancerFrance
-
Virginia Polytechnic Institute and State UniversityActive, not recruitingRelative Energy Deficiency in SportUnited States
-
Fundación Santa Fe de BogotaInstituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS)SuspendedBone Loss, Age-Related,
-
University of Southern CaliforniaRecruiting
-
Johns Hopkins Bloomberg School of Public HealthTime-sharing Experiments for the Social SciencesCompletedFood Selection | AttitudeUnited States
-
3-C Institute for Social DevelopmentCompletedSocial Skills | Trauma, Psychological | Family DysfunctionalUnited States