NCT02702596

Brief 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 Measurement-Based Integrated Care (MBIC) model with collaborative, multi-disciplinary treatment and culturally tailored care management strategies.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for not_applicable depression

Timeline
Completed

Started Feb 2016

Typical duration for not_applicable depression

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 3, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 8, 2016

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2019

Completed
Last Updated

May 19, 2023

Status Verified

May 1, 2023

Enrollment Period

3 years

First QC Date

March 3, 2016

Last Update Submit

May 17, 2023

Conditions

Depression

Outcome Measures

Primary Outcomes (2)

  • Number of participants who engage in depression treatment

    baseline to one month post education session

  • Change in PHQ-9 (depressive symptoms) scores

    baseline compared to one year post enrollment

Secondary Outcomes (1)

  • Number of primary care patients screened for depression using the iPad technology

    two year participant enrollment period

Study Arms (2)

MBIC + DEF

EXPERIMENTAL

Measurement-Based Integrated Care with Depression Education Fotonovela

Other: Measurement-Based Integrated CareBehavioral: Depression Education Fotonovela

MBIC + SE

EXPERIMENTAL

Measurement-Based Integrated Care + Standard Education

Other: Measurement-Based Integrated CareBehavioral: Standard Education

Interventions

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

MBIC + DEFMBIC + SE
Depression Education FotonovelaBEHAVIORAL

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

MBIC + DEF
Standard EducationBEHAVIORAL

The the use of a pamphlet to educate people about depression.

MBIC + SE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult primary care patients
  • Hispanic
  • Meets diagnostic criteria for depression

You may not qualify if:

  • currently in treatment for depression

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 34949169DERIVED

  • Sanchez 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.

    PMID: 28774339DERIVED

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Katherine Sanchez, PhD

    University of Texas at Arlington

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2016

First Posted

March 8, 2016

Study Start

February 1, 2016

Primary Completion

January 15, 2019

Study Completion

January 15, 2019

Last Updated

May 19, 2023

Record last verified: 2023-05