NCT00709150

Brief Summary

This study will evaluate the effectiveness of culturally adapted depression treatment for reducing depressive symptoms and improving adherence to diabetes self-care regimens in Hispanics with depression and diabetes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
387

participants targeted

Target at P75+ for phase_4 depression

Timeline
Completed

Started Mar 2005

Typical duration for phase_4 depression

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

March 1, 2005

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

June 30, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 3, 2008

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

November 22, 2023

Status Verified

July 1, 2013

Enrollment Period

4.5 years

First QC Date

June 30, 2008

Last Update Submit

November 20, 2023

Conditions

Depression

Keywords

Major DepressionDiabetesHispanicsCollaborative Depression Care Management

Outcome Measures

Primary Outcomes (1)

  • Reduction in symptoms of major depression

    Measured at Months 12, 18, and 24

Secondary Outcomes (1)

  • Quality of life

    Measured at Months 12, 18, and 24

Study Arms (2)

1

EXPERIMENTAL

Patients will receive collaborative depression care management.

Behavioral: Collaborative depression care management

2

ACTIVE COMPARATOR

Patients will receive enhanced usual care.

Behavioral: Enhanced usual care

Interventions

Collaborative depression care managementBEHAVIORAL

Collaborative depression care management will include acute depression treatment with antidepressant medication and/or counseling sessions based on structured problem solving therapy. Participants will also receive supportive patient navigation services and maintenance/relapse telephone monitoring. Counseling treatment will include 8 weekly 45-minute counseling sessions that are socio-culturally adaptated for the study population. The length of medication treatment will depend upon participants' severity of depression and may last up to 12 months.

1
Enhanced usual careBEHAVIORAL

Participants will receive educational pamphlets on depression and a list of mental health resources in the community. Participants' primary care doctors will be free to prescribe antidepressant medication or provide other usual care.

2

Eligibility Criteria

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

You may qualify if:

  • Meets criteria for major depression based on a score of greater than 2 for five or more symptoms, including one of the two cardinal depression symptoms and a nine-item depression scale of the Patient Health Questionnaire (PHQ-9) score of greater than 10
  • Patient with diabetes
  • Has attended two community safety net clinics

You may not qualify if:

  • Current suicidal ideation
  • Score of 8 or greater on the Alcohol Use Disorders Identification Test (AUDIT)
  • Recent use of lithium or antipsychotic medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Southern California School of Social Work

Los Angeles, California, 90089-0411, United States

Location

Related Publications (3)

  • Ell K, Katon W, Lee PJ, Kapetanovic S, Guterman J, Xie B, Chou CP. Depressive symptom deterioration among predominantly Hispanic diabetes patients in safety net care. Psychosomatics. 2012 Jul-Aug;53(4):347-55. doi: 10.1016/j.psym.2011.12.009. Epub 2012 Mar 27.

    PMID: 22458987DERIVED

  • Hay JW, Katon WJ, Ell K, Lee PJ, Guterman JJ. Cost-effectiveness analysis of collaborative care management of major depression among low-income, predominantly Hispanics with diabetes. Value Health. 2012 Mar-Apr;15(2):249-54. doi: 10.1016/j.jval.2011.09.008. Epub 2011 Dec 15.

    PMID: 22433755DERIVED

  • Ell K, Katon W, Xie B, Lee PJ, Kapetanovic S, Guterman J, Chou CP. One-year postcollaborative depression care trial outcomes among predominantly Hispanic diabetes safety net patients. Gen Hosp Psychiatry. 2011 Sep-Oct;33(5):436-42. doi: 10.1016/j.genhosppsych.2011.05.018. Epub 2011 Jul 19.

    PMID: 21774987DERIVED

MeSH Terms

Conditions

DepressionDepressive Disorder, MajorDiabetes Mellitus

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorDepressive DisorderMood DisordersMental DisordersGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Kathleen R. Ell, DSW

    University of Southern California

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 30, 2008

First Posted

July 3, 2008

Study Start

March 1, 2005

Primary Completion

September 1, 2009

Study Completion

September 1, 2009

Last Updated

November 22, 2023

Record last verified: 2013-07

Locations

US(1)