Major DepressionIMPACTNCT01561105
Improving Depression Care for Elders: Coordinating Center
A study testing IMPACT in people with Major Depression and Dysthymic Disorder, run by University of California, Los Angeles.
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Major Depression, Dysthymic Disorder, Both Major Depression and Dysthymic Disorder
- What is being tested?
- IMPACT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,801 participants
- Where
- No sites listed yet
- Study dates
- Jan 1999to Jun 2004
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
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.
Purpose: To determine the effectiveness of the Improving Mood-Promoting Access to Collaborative Treatment(IMPACT) collaborative care management program for late-life depression.
Read the 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.
- Being tested
- IMPACT
- Medical subject headings
- Depressive Disorder, Major, Dysthymic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMPACTOther
Also called Improving Mood-Promoting Access to Collaborative Treatment
IMPACT is a collaborative care management program for late-life depression
| Study group | Role | What they receive |
|---|---|---|
| IMPACT | Experimental | Not described Receives: Other: IMPACT |
| Care as Usual | No intervention | Patients received all depression care available to them as part of care as usual in the participating primary care clinics. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of depression symptoms
Severity measured by the 21-item Hopkins Symptom Checklist.
Secondary outcomes (1)
Functioning
measured by the Sheehan Health-Related Functioning Index
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2012 (estimated)
- Study startJan 1999
- Primary completionJun 2004
- Study completionJun 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Major DepressionStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,801 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- The John A. Hartford Foundation, California HealthCare Foundation, Hogg Foundation, Robert Wood Johnson Foundation
- Responsible party
- Principal investigator, Jurgen Unutzer, MD, MPH, University of Washington
- Investigators
- Jurgen Unutzer, MD, MPH, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01561105
- Sponsor's protocol ID
- JAHF 98297
- Acronym
- IMPACT
- Status last verified
- Mar 2012
- First submitted
- 20 Mar 2012
- Last updated
- 28 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 12472325Stewart 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.
PubMed 24367124
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01561105
- Acronym / sponsor ID
- IMPACT / JAHF 98297
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,801 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- The John A. Hartford Foundation, California HealthCare Foundation, Hogg Foundation, Robert Wood Johnson Foundation
- Study start
- Jan 1999
- Primary completion
- Jun 2004 (actual)
- Study completion
- Jun 2004 (actual)
- First posted
- 22 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IMPACT | Experimental | Other: IMPACT |
| Care as Usual | No intervention | –Patients received all depression care available to them as part of care as usual in the participating primary care clinics. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IMPACTAlso: Improving Mood-Promoting Access to Collaborative TreatmentIMPACT is a collaborative care management program for late-life depression | Other | IMPACT |
Primary outcome
Severity of depression symptoms
Severity measured by the 21-item Hopkins Symptom Checklist.
1 secondary outcome
Functioning
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2012.
- Results publication: PubMed 12472325Unutzer 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.
- Derived from this study: PubMed 24367124Stewart 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jurgen Unutzer, MD, MPH principal investigator
University of Washington
Questions about this trial
What is this clinical trial studying?
A study testing IMPACT in people with Major Depression and Dysthymic Disorder, run by University of California, Los Angeles.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severity of depression symptoms. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01561105, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2012.