Effectiveness of Culturally Based Congruent Care in Treating Hispanics With Major Depressive Disorder

NCT00247195 | Completed

• 3 other identifiers: #4985R34MH073087DSIR 82-SESC
• Study Type: interventional
• Target: 113
• Locations: 1 country
• Sites: 1

Brief Summary

This study will develop and evaluate the effectiveness of a culturally based program that aims to facilitate entry, retention, and successful treatment in specialized mental health services for Hispanics with major depressive disorder.

Conditions

Depression

Keywords

Major Depression; MDD; Hispanic; Primary Care; Cultural Congruence

Outcome Measures

Primary Outcomes (3)

• Entry into specialty mental health care from primary care

  Measured at study completion

• Entry into treatment for major depressive disorder after evaluation

  Measured at study completion

• Dropout from stepped care

  Measured throughout the study

Secondary Outcomes (11)

• Score on the Hamilton Depression Scale (17-item)

  Measured at Week 30

• Score on the Clinical Global Impression Scale

  Measured at Week 30

• Score on the Working Alliance Inventory

  Measured at Week 18

• Score on the Client Satisfaction Questionnaire

  Measured at Week 18

• Score on the Side Effects Checklist

  Measured at Week 18

Study Arms (2)

Culturally congruent assessment and treatment

EXPERIMENTAL

Outreach by phone to primary care patients interested in mental health referral. Engagement and evaluation approach conducted using the DSM-IV cultural formulation model. Same treatment choices as in control arm (medication, interpersonal psychotherapy, and combination treatment).

Behavioral: Culturally Congruent Assessment and Treatment

Usual referral and treatment

ACTIVE COMPARATOR

Usual referral procedure from primary care: PC clinician gives patient information on how to access mental health care at research site. Usual engagement and evaluation approach without using cultural formulation model. Same treatment choices (medication, interpersonal psychotherapy, and combination treatment) as in experimental arm.

Behavioral: Culturally Congruent Assessment and Treatment

Interventions

Culturally Congruent Assessment and Treatment BEHAVIORAL

Referral, engagement, and treatment is done following the cultural formulation model in DSM-IV in which patients' views and expectations about depression treatment are included in the assessment and treatment process.

Culturally congruent assessment and treatment; Usual referral and treatment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• PHASE 1 FOCUS GROUP 1:
• Self-identifies as Hispanic
• Screened positive for MDD during the previous study (WH-PCDP), but was unable to participate in that study due to ongoing depression treatment at the time
• Spanish-speaking
• PHASE 1 FOCUS GROUP 2:
• Self-identifies as Hispanic
• Family member of a patient with MDD who participated in the previous study (WH-PCDP)
• Spanish-speaking
• PHASES 1-3:
• Pre-Engagement Phase
• Self-identifies as Hispanic
• Spanish-speaking
• Positive screen for MDD on the Patient Health Questionnaire (PHQ) and a preliminary diagnosis of MDD from the primary care physician during a standard medical interview
• Treatment Phase
• Meets DSM-IV criteria for MDD

You may not qualify if:

• PHASE 1 FOCUS GROUP 1:
• Comorbid medical or psychiatric conditions that may prevent focus group participation (e.g., substance use disorders, psychosis, unstable medical conditions)
• Active suicidal or homicidal ideation that may pose a danger to oneself or others
• PHASE 1 FOCUS GROUP 2:
• Comorbid medical or psychiatric conditions that may prevent focus group participation (e.g., substance use disorders, psychosis, unstable medical conditions)
• PHASES 1-3:
• Pre-Engagement Phase
• Declines referral by a primary care physician to specialized mental health services
• Comorbid medical or psychiatric conditions that may prevent safe study participation (e.g., substance use disorders, psychosis, unstable medical conditions)
• Active suicidal or homicidal ideation that may pose a danger to oneself or others
• Treatment Phase
• History of schizophrenia, bipolar disorder, schizoaffective disorder, depression with psychotic symptoms, or organic brain syndromes
• Clinically unstable medical disease, including glaucoma
• Blood pressure higher than 150/90
• Pregnant or breastfeeding

Sponsors & Collaborators

• New York State Psychiatric Institute: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

New York State Psychiatric Institute - Hispanic Treatment Program

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Depression; Depressive Disorder, Major

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Roberto Lewis-Fernandez, MD

  New York State Psychiatric Institute

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: October 28, 2005
• First Posted: November 1, 2005
• Study Start: November 1, 2005
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: October 25, 2012

Record last verified: 2012-10

Locations

US (1)