NCT02017262

Brief Summary

This project addresses the important public health need to reduce ethnic disparities in depression care by pilot testing and refining a culturally tailored, low-cost intervention for improving both depression and general medical outcomes among Latinos in safety net primary care settings. Cuerpo Sano, Mente Sana is a newly developed, lay-led, group self-management intervention that educates and empowers patients in their own health care and has the potential for widespread implementation and sustainability in primary care because it is responsive to patient, provider, and system preferences and needs. After completing an assessment of study clinic sites, we will conduct a pilot test of Cuerpo Sano, Mente Sana with 30 low-income, Spanish-speaking primary care patients. After reviewing pilot findings, we will revise the intervention and study plan, and will conduct a second pilot trial. After reviewing findings from this second trial, we will finalize the intervention and study plan in preparation for larger studies to test Cuerpo Sano, Mente Sana versus other interventions for addressing depression among Latinos in safety net primary care.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
76

participants targeted

Target at P25-P50 for not_applicable depression

Timeline
Completed

Started Sep 2013

Geographic Reach
1 country

1 active site

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

September 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 10, 2013

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 20, 2013

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

April 4, 2017

Status Verified

March 1, 2017

Enrollment Period

1.8 years

First QC Date

December 10, 2013

Last Update Submit

March 31, 2017

Conditions

DepressionChronic DiseaseHispanic Americans

Keywords

Self-carePatient education

Outcome Measures

Primary Outcomes (1)

  • Depressive symptom severity (Hopkins Symptoms Checklist, or SCL)

    Change from baseline in depressive symptom severity at 3-months

Secondary Outcomes (1)

  • Health-related quality of life (Short-Form-12)

    Change from baseline in health-related quality of life at 3-months

Study Arms (2)

Self-management group

EXPERIMENTAL

8 weekly sessions of group self-management

Behavioral: Self-management group

Enhanced usual care

ACTIVE COMPARATOR

Usual care by primary care provider, plus educational pamphlet about depression, list of local mental health resources, and letter for provider advising him/her of depression diagnosis

Behavioral: Enhanced usual care

Interventions

Self-management groupBEHAVIORAL

8 weekly sessions of group self-management

Also known as: Self-care, Patient education
Self-management group
Enhanced usual careBEHAVIORAL

Usual care by primary care provider, plus educational pamphlet about depression, list of local mental health resources, and letter for provider advising him/her of depression diagnosis

Enhanced usual care

Eligibility Criteria

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

You may qualify if:

  • Established primary care patient
  • Spanish-speaking
  • Depression (major depression, dysthymia, minor depression)
  • Chronic medical illness (diabetes, hypertension, dyslipidemia, heart disease, lung disease, cerebrovascular disease, arthritis)

You may not qualify if:

  • Bipolar disorder
  • Psychosis
  • Cognitive impairment
  • Active suicidal ideation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

LAC+USC Medical Center, Primary Care Clinics

Los Angeles, California, 90033, United States

Location

MeSH Terms

Conditions

DepressionChronic Disease

Interventions

Self CarePatient Education as Topic

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitationHealth ServicesHealth Care Facilities Workforce and ServicesHealth EducationPreventive Health Services

Study Officials

  • Megan Dwight-Johnson, MD MPH

    VA Medical Center-West Los Angeles

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 10, 2013

First Posted

December 20, 2013

Study Start

September 1, 2013

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

April 4, 2017

Record last verified: 2017-03

Locations

US(1)