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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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:

  1. 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.
  2. 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.
  3. 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:

  1. 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.
  2. 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 groups in NCT02491034
Study groupRoleWhat they receive
InterventionOtherDepression Education Intervention
Receives: Behavioral: Depression Education Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

  1. First posted7 Jul 2015 (estimated)
  2. Study startJan 2015
  3. Primary completion30 Sep 2017
  4. Study completion30 Sep 2017

Resources

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)
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 31638915
  • Lopez 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 29788998
  • Sanchez 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

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.

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