Effectiveness of Culturally Based Congruent Care in Treating Hispanics With Major Depressive Disorder - Full Text View

Sponsor:	National Institute of Mental Health (NIMH)
Information provided by:	National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:	NCT00247195

Purpose

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.

Condition	Intervention
Depression	Behavioral: Culturally Congruent Assessment and Treatment

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Culturally Congruent Care for Hispanic Outpatients With Major Depressive Disorder (MDD)

Resource links provided by NLM:

MedlinePlus related topics: Depression Mental Health

U.S. FDA Resources

Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:

Entry into specialty mental health care from primary care [ Time Frame: Measured at study completion ] [ Designated as safety issue: No ]
Entry into treatment for major depressive disorder after evaluation [ Time Frame: Measured at study completion ] [ Designated as safety issue: No ]
Dropout from stepped care [ Time Frame: Measured throughout the study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Score on the Hamilton Depression Scale (17-item) [ Time Frame: Measured at Week 30 ] [ Designated as safety issue: No ]
Score on the Clinical Global Impression Scale [ Time Frame: Measured at Week 30 ] [ Designated as safety issue: No ]
Score on the Working Alliance Inventory [ Time Frame: Measured at Week 18 ] [ Designated as safety issue: No ]
Score on the Client Satisfaction Questionnaire [ Time Frame: Measured at Week 18 ] [ Designated as safety issue: No ]
Score on the Side Effects Checklist [ Time Frame: Measured at Week 18 ] [ Designated as safety issue: No ]
Score on the Quality of Life Index [ Time Frame: Measured at Week 30 ] [ Designated as safety issue: No ]
Score on the Social Adjustment Scale - Self-report version [ Time Frame: Measured at Week 30 ] [ Designated as safety issue: No ]
Score on the Client Satisfaction Questionnaire [ Time Frame: Measured at Week 30 ] [ Designated as safety issue: No ]
Score on the Nervios Treatment Scale [ Time Frame: Measured at Week 30 ] [ Designated as safety issue: No ]
Score on the Working Alliance Inventory [ Time Frame: Measured at Week 30 ] [ Designated as safety issue: No ]
Score on the Clinical Global Impression Scale - Patient version [ Time Frame: Measured at Week 30 ] [ Designated as safety issue: No ]

Estimated Enrollment:	105
Study Start Date:	November 2005
Estimated Study Completion Date:	February 2010
Estimated Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 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.
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 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.

Detailed Description:

Major depressive disorder (MDD) is a type of depression that is characterized by a combination of symptoms that can interfere with the ability to work, study, sleep, eat, and enjoy activities that were once pleasurable. Studies have shown that individuals of Hispanic descent underutilize specialized mental health care services (SMHS), despite their need for it. In addition, Hispanic individuals have been associated with lower rates of retention in specialized mental health treatment. In particular, dropout rates from medication therapy for the treatment of MDD within SMHS are two to three times higher in Hispanics than in non-Hispanic whites. 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 MDD.

This open-label study will consist of four phases. Participants will be recommended for inclusion in the study upon receiving a diagnosis of MDD based on a standard health questionnaire completed in their primary care physician's office. Phase 1 of the study will entail an initial evaluation of the culturally congruent program of care for Hispanics with MDD (CCP-MDD). Participants will be placed in one of two focus groups, each composed of 8 to 10 people. One group will include individuals referred by their primary care physician. The other group will include family members of Hispanics with MDD. Discussions will focus on participants' understandings of depression-like illness, their treatment expectations for these conditions, and their perceived barriers to SMHS utilization. Information gathered in the focus groups will be used to develop a second version of CCP-MDD. Phase 2 of the study will evaluate the revised version of CCP-MDD and will include additional treatments with antidepressant medication, weekly interpersonal psychotherapy, or a combination of the two. Following treatment, participants will take part in a focus group, which will involve participant feedback.

Based on the information obtained in the focus groups and from clinical observations, a third version of CCP-MDD will be developed. In Phase 3, two sets of primary care offices will participate. One set will be assigned to the intervention arm, and receive the third version of the CCP-MDD intervention. A second set will be assigned to the control arm and receive usual referral to mental health services at the research site. All participants will be offered the same choice of treatments: antidepressant medication, weekly interpersonal psychotherapy, or a combination of the two. Treatment in both arms will be of the same duration, 18 wks. Focus groups will be held following treatment in order to obtain information about individuals' satisfaction or dissatisfaction with their care. Based on these findings, as well as clinical observations, a fourth and final version of CCP-MDD will be developed in Phase 4. All treatments will last a total of 18 weeks. A follow-up session will be held at Week 30 to assess depressive symptoms.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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
Score of at least 16 on the Hamilton Depression Scale (HAM-D17) at the time of study entry
Willing to abstain from any other type of specialized mental health services for the duration of the treatment (participants in general health care or participating in folk/spiritual healing practices are expected to continue these during the study)
Ability to tolerate a drug-free period (2 weeks for most medications; 4 weeks for fluoxetine) if on an ineffective psychotropic medication; if current medication is effective, participants will not be asked to discontinue it (zolpidem for insomnia is also a permitted medication)
Agrees to use an effective form of contraception for the duration of the study

Exclusion Criteria

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
Current or past history of seizure disorder (except febrile seizure in childhood)
Meets DSM-IV criteria for alcohol or substance abuse or dependence (except nicotine) within the 6 months prior to screening
Use of monoamine oxidase inhibitors (MAOIs) or fluoxetine within 4 weeks prior to screening, or use of other selective serotonin reuptake inhibitors (SSRIs), antidepressants, neuroleptics, mood stabilizers, buspirone, benzodiazepines, or other psychotropic drugs, except zolpidem for insomnia within 2 weeks prior to screening
Currently receiving formal psychotherapy from a mental health provider, whether or not the focus of the therapy is MDD

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00247195

Contacts

Contact: Melissa Rosario

212-543-6514

rosario@nyspi.cpmc.columbia.edu

Locations

United States, New York
New York State Psychiatric Institute - Hispanic Treatment Program	Recruiting
New York, New York, United States, 10032
Contact: Melissa Rosario 212-543-6514 rosario@nyspi.cpmc.columbia.edu
Principal Investigator: Roberto Lewis-Ferandez, MD

Sponsors and Collaborators

National Institute of Mental Health (NIMH)

Investigators

Principal Investigator:

Roberto Lewis-Fernandez, MD

New York State Psychiatric Institute

More Information

No publications provided

Responsible Party:	Hispanic Trtment Program, NYS Psych Inst, Dept Psychiatry, Columbia Univ ( Roberto Lewis-Fernandez, MD )
Study ID Numbers:	R34 MH073087, DSIR 82-SESC
Study First Received:	October 28, 2005
Last Updated:	March 4, 2009
ClinicalTrials.gov Identifier:	NCT00247195 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):

Major Depression
MDD
Hispanic
Primary Care
Cultural Congruence

Additional relevant MeSH terms:

Depression
Mental Disorders
Mood Disorders

Depressive Disorder, Major
Depressive Disorder
Behavioral Symptoms

ClinicalTrials.gov processed this record on November 05, 2009