DepressionNCT02702596
METRIC: Measurement, Education and Tracking in Integrated Care
A study testing Measurement-Based Integrated Care, Depression Education Fotonovela and Standard Education in people with Depression, run by The University of Texas at Arlington.
Trial summary
The proposed study seeks to establish the feasibility of universal screening for depression in an adult primary care safety net setting, measure the effectiveness of a culturally appropriate depression education intervention to reduce stigma and increase uptake in depression treatment among Hispanics, and implement a… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression
- What is being tested?
- Measurement-Based Integrated Care, Depression Education Fotonovela and Standard Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- Feb 2016to 15 Jan 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult primary care patients
- Hispanic
- Meets diagnostic criteria for depression
Who cannot join
- currently in treatment for depression
About this study
Official title: METRIC: Measurement, Education and Tracking in Integrated Care: Strategies to Increase Patient Engagement and Reduce Mental Health Disparities Among Hispanics
The proposed study seeks to establish the feasibility of universal screening for depression in an adult primary care safety net setting, measure the effectiveness of a culturally appropriate depression education intervention to reduce stigma and increase uptake in depression treatment among Hispanics, and implement a Measurement-Based Integrated Care (MBIC) model with collaborative, multi-disciplinary treatment and culturally tailored care management strategies.
Read the detailed description
Specific Aim 1: Examine the specific effects of a Depression Education Fotonovela (DEF) to increase knowledge of depression, reduce stigma and increase engagement in depression treatment among Hispanic patients.
Specific Aim 2: Evaluate the impact of Measurement-Based Integrated Care (MBIC) for the treatment of depression in one community-based Federally Qualified Health Centers (FQHC) in North Texas whose patient population is majority Hispanic.
Specific Aim 3: Examine the feasibility of universal screening and accurate detection of depression among adult primary care patients utilizing innovative iPad Depression Screening technology.
- Conditions
- Depression
- Being tested
- Measurement-Based Integrated Care, Depression Education Fotonovela, Standard Education
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurement-Based Integrated CareOther
Measurement-Based Integrated Care (MBIC) synthesizes the science of integrated health care and incorporates the strategies of measurement-based care. concept of MBIC for the treatment of depression includes: systematic assessment of symptoms, antidepressant treatment side effects and medication adherence and incorporation of a Depression Care Manager (DCM) to track patients and keep them engaged in care using behavioral interventions
Depression Education FotonovelaBehavioural
Depression education that uses a unique, culturally adapted depression fotonovela titled "Secret Feelings" developed by Cabassa, Molina and Baron (2012). The fotonovela is a popular comic-book style pamphlet that portrays a dramatic story using photographs and dialogue bubbles, which has become an effective tool for engaging Hispanic audiences and increasing knowledge about specific health issues
Standard EducationBehavioural
The the use of a pamphlet to educate people about depression.
| Study group | Role | What they receive |
|---|---|---|
| MBIC + DEF | Experimental | Measurement-Based Integrated Care with Depression Education Fotonovela Receives: Other: Measurement-Based Integrated Care; Behavioral: Depression Education Fotonovela |
| MBIC + SE | Experimental | Measurement-Based Integrated Care + Standard Education Receives: Other: Measurement-Based Integrated Care; Behavioral: Standard Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who engage in depression treatment
Measured: baseline to one month post education session
Change in PHQ-9 (depressive symptoms) scores
Measured: baseline compared to one year post enrollment
Secondary outcomes (1)
Number of primary care patients screened for depression using the iPad technology
Measured: two year participant enrollment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2016 (estimated)
- Study startFeb 2016
- Primary completion15 Jan 2019
- Study completion15 Jan 2019
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 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas at Arlington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD), University of Texas Southwestern Medical Center, Columbia University
- Responsible party
- Sponsor
- Investigators
- Katherine Sanchez, PhD, Principal investigator, University of Texas at Arlington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02702596
- Sponsor's protocol ID
- 1R15MD010220-01
- Other IDs
- R15MD010220
- Status last verified
- May 2023
- First submitted
- 3 Mar 2016
- Last updated
- 19 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Sanchez K, Eghaneyan BH, Killian MO, Cabassa LJ, Trivedi MH. Depression education fotonovela for engagement of Hispanic patients in treatment: a randomized clinical trial. BMC Psychiatry. 2021 Dec 23;21(1):635. doi: 10.1186/s12888-021-03641-0.
PubMed 34949169Sanchez K, Eghaneyan BH, Killian MO, Cabassa L, Trivedi MH. Measurement, Education and Tracking in Integrated Care (METRIC): use of a culturally adapted education tool versus standard education to increase engagement in depression treatment among Hispanic patients: study protocol for a randomized control trial. Trials. 2017 Aug 3;18(1):363. doi: 10.1186/s13063-017-2109-y.
PubMed 28774339
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- METRIC: Measurement, Education and Tracking in Integrated Care: Strategies to Increase Patient Engagement and Reduce Mental Health Disparities Among Hispanics
- ClinicalTrials.gov ID
- NCT02702596
- Acronym / sponsor ID
- 1R15MD010220-01
- Conditions
- Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- The University of Texas at ArlingtonUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD), University of Texas Southwestern Medical Center, Columbia University
- Study start
- Feb 2016 (actual)
- Primary completion
- 15 Jan 2019 (actual)
- Study completion
- 15 Jan 2019 (actual)
- First posted
- 8 Mar 2016 (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 proposed study seeks to establish the feasibility of universal screening for depression in an adult primary care safety net setting, measure the effectiveness of a culturally appropriate depression education intervention to reduce stigma and increase uptake in depression treatment among Hispanics, and implement a Measurement-Based Integrated Care (MBIC) model with collaborative, multi-disciplinary treatment and culturally tailored care management strategies.
Detailed description
Specific Aim 1: Examine the specific effects of a Depression Education Fotonovela (DEF) to increase knowledge of depression, reduce stigma and increase engagement in depression treatment among Hispanic patients.
Specific Aim 2: Evaluate the impact of Measurement-Based Integrated Care (MBIC) for the treatment of depression in one community-based Federally Qualified Health Centers (FQHC) in North Texas whose patient population is majority Hispanic.
Specific Aim 3: Examine the feasibility of universal screening and accurate detection of depression among adult primary care patients utilizing innovative iPad Depression Screening technology.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MBIC + DEF | Experimental | Other: Measurement-Based Integrated Care, Behavioral: Depression Education FotonovelaMeasurement-Based Integrated Care with Depression Education Fotonovela |
| MBIC + SE | Experimental | Other: Measurement-Based Integrated Care, Behavioral: Standard EducationMeasurement-Based Integrated Care + Standard Education |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult primary care patients
- Hispanic
- Meets diagnostic criteria for depression
Key exclusion criteria (1 listed)
- currently in treatment for depression
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 |
|---|---|---|
| Measurement-Based Integrated CareMeasurement-Based Integrated Care (MBIC) synthesizes the science of integrated health care and incorporates the strategies of measurement-based care. concept of MBIC for the treatment of depression includes: systematic assessment of symptoms, antidepressant treatment side effects and medication adherence and incorporation of a Depression Care Manager (DCM) to track patients and keep them engaged in care using behavioral interventions | Other | MBIC + DEF, MBIC + SE |
| Depression Education FotonovelaDepression education that uses a unique, culturally adapted depression fotonovela titled "Secret Feelings" developed by Cabassa, Molina and Baron (2012). The fotonovela is a popular comic-book style pamphlet that portrays a dramatic story using photographs and dialogue bubbles, which has become an effective tool for engaging Hispanic audiences and increasing knowledge about specific health issues | Behavioural | MBIC + DEF |
| Standard EducationThe the use of a pamphlet to educate people about depression. | Behavioural | MBIC + SE |
Primary outcome
Number of participants who engage in depression treatment
Time frame: baseline to one month post education session
Change in PHQ-9 (depressive symptoms) scores
Time frame: baseline compared to one year post enrollment
1 secondary outcome
Number of primary care patients screened for depression using the iPad technology
Time frame: two year participant enrollment period
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 19 May 2023.
- Derived from this study: PubMed 34949169Sanchez K, Eghaneyan BH, Killian MO, Cabassa LJ, Trivedi MH. Depression education fotonovela for engagement of Hispanic patients in treatment: a randomized clinical trial. BMC Psychiatry. 2021 Dec 23;21(1):635. doi: 10.1186/s12888-021-03641-0.
- Derived from this study: PubMed 28774339Sanchez K, Eghaneyan BH, Killian MO, Cabassa L, Trivedi MH. Measurement, Education and Tracking in Integrated Care (METRIC): use of a culturally adapted education tool versus standard education to increase engagement in depression treatment among Hispanic patients: study protocol for a randomized control trial. Trials. 2017 Aug 3;18(1):363. doi: 10.1186/s13063-017-2109-y.
- Individual participant dataSharing planned: Undecided
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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.
Katherine Sanchez, PhD principal investigator
University of Texas at Arlington
Questions about this trial
What is this clinical trial studying?
A study testing Measurement-Based Integrated Care, Depression Education Fotonovela and Standard Education in people with Depression, run by The University of Texas at Arlington.
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 3 inclusion and 1 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 19 May 2023. 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?
Number of participants who engage in depression treatment (time frame: baseline to one month post education session). The study lists 2 primary outcomes in all. 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 NCT02702596, 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 19 May 2023.