DepressionDESEONCT02491034
DESEO: DEpression Screening and Education: Options to Reduce Barriers to Treatment
A study testing Depression Education Intervention in people with Depression, run by The University of Texas at Arlington.
Trial summary
The purpose of this project is to implement a Depression Education Intervention (DEI) designed to increase disease literacy, and dispel myths about depression and its treatment among Hispanic patients thus reducing stigma and increasing treatment engagement. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depression
- What is being tested?
- Depression Education Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to 30 Sep 2017
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult primary care patients
Who cannot join
- previous diagnosis of depression and currently in treatment
About this study
The purpose of this project is to implement a Depression Education Intervention (DEI) designed to increase disease literacy, and dispel myths about depression and its treatment among Hispanic patients thus reducing stigma and increasing treatment engagement. This project will be conducted at one community health center whose patient population is majority Hispanic.
Read the detailed description
Barriers to depression treatment among Hispanic populations include persistent stigma, inadequate doctor patient communication (DPC) and resultant sub-optimal use of anti-depressant medications. Stigma is primarily perpetuated due to inadequate disease literacy and cultural factors. Common concerns about depression treatments among Hispanics include fears about the addictive and harmful properties of antidepressants, worries about taking too many pills, and the stigma attached to taking psychotropic medications.
Primary care settings often are the gateway to identifying undiagnosed or untreated mental health disorders, particularly for people with comorbid physical health conditions. Hispanics, in particular, are more likely to receive mental health care in primary care settings. Recent recommendations from the U.S. Preventive Services Task Force are that primary care providers screen adult patients for depression only if systems are in place to ensure adequate treatment and follow-up.
Project Purpose, Goals and Objectives Purpose: The purpose of this project is to implement a Depression Education Intervention (DEI) designed to increase disease literacy, and dispel myths about depression and its treatment among Hispanic patients thus reducing stigma and increasing treatment engagement. This project will be conducted at one community health center whose patient population is majority Hispanic.
Goal #1: Patients who screen positive for depression will engage in the Depression Education Intervention (DEI) (two sessions) with a trained Depression Educator.
Objectives:
- To increase knowledge of depression (signs/symptoms, causes, risk factors, treatment, cultural beliefs, and its role in chronic disease) among Hispanics in a primary care setting as measured by changes in scores from pre- to post- DEI on the Knowledge of Depression-MCQ scale.
- To reduce perceived cultural stigma about depression and its treatment through a culturally and linguistically appropriate educational intervention as measured by changes in scores from pre- to post- DEI on the Stigma Checklist for Latinos in Primary Care.
- To increase engagement in depression treatment in primary care by Hispanic patients as measured by the iPad Depression Screening application, which will record the treatment decision after the diagnosis and measure the number of patients engaged in depression treatment of any kind (pharmacotherapy, counseling, other behavioral intervention) at the time of the DEI and one month after completion of the DEI.
Goal #2: In order to identify patients with depression, all adult primary care patients will be screened for depression utilizing the 9-item Patient Health Questionnaire (PHQ-9) via the iPad Depression Screening application.
Objectives:
- To systematically screen all adult primary care patients with an iPad Depression Screening application as measured by number of patients screened compared to the number eligible for screening.
- To increase provider detection of depression in patients through the proper use and interpretation of the PHQ-9 as measured by depression diagnoses recorded in the EHR.
- Conditions
- Depression
- Being tested
- Depression Education Intervention
- Keywords
- Depression, Hispanics, Stigma, Barriers to Treatment
- Medical subject headings
- Depression, Social Stigma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Depression Education InterventionBehavioural
Depression Education Intervention (DEI) designed to increase disease literacy, and dispel myths about depression and its treatment among Hispanic patients thus reducing stigma and increasing treatment engagement.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Other | Depression Education Intervention Receives: Behavioral: Depression Education Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of Hispanic patients diagnosed with depression who went on to begin depression treatment.
Measured: One month post DEI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2015 (estimated)
- Study startJan 2015
- Primary completion30 Sep 2017
- Study completion30 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas at Arlington
- Sponsor type
- University, hospital or other
- Collaborators
- University of Texas Southwestern Medical Center
- Responsible party
- Sponsor
- Investigators
- Katherine Sanchez, PhD, Principal investigator, The University of Texas at Arlington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02491034
- Sponsor's protocol ID
- 2015-0336
- Acronym
- DESEO
- Status last verified
- Jul 2018
- First submitted
- 2 Jul 2015
- Last updated
- 10 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sanchez K, Killian MO, Eghaneyan BH, Cabassa LJ, Trivedi MH. Culturally adapted depression education and engagement in treatment among Hispanics in primary care: outcomes from a pilot feasibility study. BMC Fam Pract. 2019 Oct 21;20(1):140. doi: 10.1186/s12875-019-1031-7.
PubMed 31638915Lopez V, Sanchez K, Killian MO, Eghaneyan BH. Depression screening and education: an examination of mental health literacy and stigma in a sample of Hispanic women. BMC Public Health. 2018 May 22;18(1):646. doi: 10.1186/s12889-018-5516-4.
PubMed 29788998Sanchez K, Eghaneyan BH, Trivedi MH. Depression Screening and Education: Options to Reduce Barriers to Treatment (DESEO): protocol for an educational intervention study. BMC Health Serv Res. 2016 Jul 29;16:322. doi: 10.1186/s12913-016-1575-3.
PubMed 27473569
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DESEO: DEpression Screening and Education: Options to Reduce Barriers to Treatment
- ClinicalTrials.gov ID
- NCT02491034
- Acronym / sponsor ID
- DESEO / 2015-0336
- Conditions
- Depression
- Keywords
- Depression, Hispanics, Stigma, Barriers to Treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- The University of Texas at ArlingtonUniversity, hospital or other
- Collaborators
- University of Texas Southwestern Medical Center
- Study start
- Jan 2015 (actual)
- Primary completion
- 30 Sep 2017 (actual)
- Study completion
- 30 Sep 2017 (actual)
- First posted
- 7 Jul 2015 (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 project is to implement a Depression Education Intervention (DEI) designed to increase disease literacy, and dispel myths about depression and its treatment among Hispanic patients thus reducing stigma and increasing treatment engagement. This project will be conducted at one community health center whose patient population is majority Hispanic.
Detailed description
Barriers to depression treatment among Hispanic populations include persistent stigma, inadequate doctor patient communication (DPC) and resultant sub-optimal use of anti-depressant medications. Stigma is primarily perpetuated due to inadequate disease literacy and cultural factors. Common concerns about depression treatments among Hispanics include fears about the addictive and harmful properties of antidepressants, worries about taking too many pills, and the stigma attached to taking psychotropic medications.
Primary care settings often are the gateway to identifying undiagnosed or untreated mental health disorders, particularly for people with comorbid physical health conditions. Hispanics, in particular, are more likely to receive mental health care in primary care settings. Recent recommendations from the U.S. Preventive Services Task Force are that primary care providers screen adult patients for depression only if systems are in place to ensure adequate treatment and follow-up.
Project Purpose, Goals and Objectives Purpose: The purpose of this project is to implement a Depression Education Intervention (DEI) designed to increase disease literacy, and dispel myths about depression and its treatment among Hispanic patients thus reducing stigma and increasing treatment engagement. This project will be conducted at one community health center whose patient population is majority Hispanic.
Goal #1: Patients who screen positive for depression will engage in the Depression Education Intervention (DEI) (two sessions) with a trained Depression Educator.
Objectives:
- To increase knowledge of depression (signs/symptoms, causes, risk factors, treatment, cultural beliefs, and its role in chronic disease) among Hispanics in a primary care setting as measured by changes in scores from pre- to post- DEI on the Knowledge of Depression-MCQ scale.
- To reduce perceived cultural stigma about depression and its treatment through a culturally and linguistically appropriate educational intervention as measured by changes in scores from pre- to post- DEI on the Stigma Checklist for Latinos in Primary Care.
- To increase engagement in depression treatment in primary care by Hispanic patients as measured by the iPad Depression Screening application, which will record the treatment decision after the diagnosis and measure the number of patients engaged in depression treatment of any kind (pharmacotherapy, counseling, other behavioral intervention) at the time of the DEI and one month after completion of the DEI.
Goal #2: In order to identify patients with depression, all adult primary care patients will be screened for depression utilizing the 9-item Patient Health Questionnaire (PHQ-9) via the iPad Depression Screening application.
Objectives:
- To systematically screen all adult primary care patients with an iPad Depression Screening application as measured by number of patients screened compared to the number eligible for screening.
- To increase provider detection of depression in patients through the proper use and interpretation of the PHQ-9 as measured by depression diagnoses recorded in the EHR.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Other | Behavioral: Depression Education InterventionDepression Education Intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult primary care patients
Key exclusion criteria (1 listed)
- previous diagnosis of depression and currently in treatment
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 |
|---|---|---|
| Depression Education InterventionDepression Education Intervention (DEI) designed to increase disease literacy, and dispel myths about depression and its treatment among Hispanic patients thus reducing stigma and increasing treatment engagement. | Behavioural | Intervention |
Primary outcome
The number of Hispanic patients diagnosed with depression who went on to begin depression treatment.
Time frame: One month post DEI
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 10 Jul 2018.
- Derived from this study: PubMed 31638915Sanchez K, Killian MO, Eghaneyan BH, Cabassa LJ, Trivedi MH. Culturally adapted depression education and engagement in treatment among Hispanics in primary care: outcomes from a pilot feasibility study. BMC Fam Pract. 2019 Oct 21;20(1):140. doi: 10.1186/s12875-019-1031-7.
- Derived from this study: PubMed 29788998Lopez V, Sanchez K, Killian MO, Eghaneyan BH. Depression screening and education: an examination of mental health literacy and stigma in a sample of Hispanic women. BMC Public Health. 2018 May 22;18(1):646. doi: 10.1186/s12889-018-5516-4.
- Derived from this study: PubMed 27473569Sanchez K, Eghaneyan BH, Trivedi MH. Depression Screening and Education: Options to Reduce Barriers to Treatment (DESEO): protocol for an educational intervention study. BMC Health Serv Res. 2016 Jul 29;16:322. doi: 10.1186/s12913-016-1575-3.
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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
The University of Texas at Arlington
Questions about this trial
What is this clinical trial studying?
A study testing Depression Education Intervention 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 1 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 10 Jul 2018. 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?
The number of Hispanic patients diagnosed with depression who went on to begin depression treatment. (time frame: One month post DEI). 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 NCT02491034, which also lists 3 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 10 Jul 2018.