DepressionPhase 2NCT00571454
Culturally Sensitive Depression Care Management for Latino Primary Care Patients
A Phase 2 study testing telephone depression care management in people with Depression, run by Butler Hospital at 1 site in United States.
Trial summary
The purpose of this study is to determine whether telephonic depression care management can improve depression outcomes for Latino primary care patients who are enrolled in Medicaid and are receiving an antidepressant from their primary care doctor. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression
- What is being tested?
- telephone depression care management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- May 2007to Aug 2008
- Phase
- Phase 2
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Latino
- Adult
- Received an antidepressant prescription from primary care provider
- Not current receiving care from behavioral health provider
- Diagnosis of major depression, minor depression, dysthymia, or significant depression symptoms
- English or Spanish speaking
- Member, Neighborhood Health Plan of RI
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Neighborhood Health Plan of RI
Providence, Rhode Island, 02908
About this study
The purpose of this study is to determine whether telephonic depression care management can improve depression outcomes for Latino primary care patients who are enrolled in Medicaid and are receiving an antidepressant from their primary care doctor.
- Conditions
- Depression
- Being tested
- telephone depression care management
- Keywords
- depression, primary care, Latino, telephone, care management
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
telephone depression care managementBehavioural
1 call per week for first 4 weeks
1 call every other week for next 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Telephone depression care management + treatment as usual Receives: Behavioral: telephone depression care management |
| 2 | No intervention | Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quick Inventory of Depressive Symptomatology - Clinician Administered (QIDS-C)
Measured: 3 months
Secondary outcomes (5)
Center for Epidemiological Studies-- Depression
Measured: 3 months
WHO Disability Assessment Schedule (WHO-DAS)
Measured: 3 months
Treatment Utilization
Measured: 3 months
Treatment Satisfaction
Measured: 3 months
costs: health care utilization
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2007 (estimated)
- Study startMay 2007
- Primary completionAug 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Butler Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Neighborhood health Plan of RI, Beacon Health Strategies, Robert Wood Johnson Foundation
- Investigators
- Beth Ann Marootian, MPH, Principal investigator, Neighborhood health Plan of RIIvan W Miller, PhD, Principal investigator, Butler HospitalLisa A Uebelacker, PhD, Principal investigator, Butler Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00571454
- Sponsor's protocol ID
- RWJ
- Status last verified
- Oct 2009
- First submitted
- 10 Dec 2007
- Last updated
- 30 Oct 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Uebelacker LA, Marootian BA, Tigue P, Haggarty R, Primack JM, Miller IW. Telephone depression care management for Latino Medicaid health plan members: a pilot randomized controlled trial. J Nerv Ment Dis. 2011 Sep;199(9):678-83. doi: 10.1097/NMD.0b013e318229d100.
PubMed 21878782
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Culturally Sensitive Depression Care Management for Latino Primary Care Patients
- ClinicalTrials.gov ID
- NCT00571454
- Acronym / sponsor ID
- RWJ
- Conditions
- Depression
- Keywords
- depression, primary care, Latino, telephone, care management
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Butler HospitalUniversity, hospital or other
- Collaborators
- Neighborhood health Plan of RI, Beacon Health Strategies, Robert Wood Johnson Foundation
- Study start
- May 2007
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 12 Dec 2007 (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.
The purpose of this study is to determine whether telephonic depression care management can improve depression outcomes for Latino primary care patients who are enrolled in Medicaid and are receiving an antidepressant from their primary care doctor.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: telephone depression care managementTelephone depression care management + treatment as usual |
| 2 | No intervention | –Treatment as usual |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Latino
- Adult
- Received an antidepressant prescription from primary care provider
- Not current receiving care from behavioral health provider
- Diagnosis of major depression, minor depression, dysthymia, or significant depression symptoms
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| telephone depression care management1 call per week for first 4 weeks 1 call every other week for next 8 weeks | Behavioural | 1 |
Primary outcome
Quick Inventory of Depressive Symptomatology - Clinician Administered (QIDS-C)
Time frame: 3 months
5 secondary outcomes
Center for Epidemiological Studies-- Depression
Time frame: 3 months
WHO Disability Assessment Schedule (WHO-DAS)
Time frame: 3 months
Treatment Utilization
Time frame: 3 months
Treatment Satisfaction
Time frame: 3 months
costs: health care utilization
Time frame: 3 months
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 30 Oct 2009.
- Derived from this study: PubMed 21878782Uebelacker LA, Marootian BA, Tigue P, Haggarty R, Primack JM, Miller IW. Telephone depression care management for Latino Medicaid health plan members: a pilot randomized controlled trial. J Nerv Ment Dis. 2011 Sep;199(9):678-83. doi: 10.1097/NMD.0b013e318229d100.
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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.
Beth Ann Marootian, MPH principal investigator
Neighborhood health Plan of RI
Ivan W Miller, PhD principal investigator
Butler Hospital
Lisa A Uebelacker, PhD principal investigator
Butler Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing telephone depression care management in people with Depression, run by Butler Hospital at 1 site in United States.
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 7 inclusion and 0 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 30 Oct 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Quick Inventory of Depressive Symptomatology - Clinician Administered (QIDS-C) (time frame: 3 months). 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 NCT00571454, which also lists 1 linked publication.
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 30 Oct 2009.