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

Primary Purpose

Depression

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Culturally Congruent Assessment and Treatment
Sponsored by
New York State Psychiatric Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring Major Depression, MDD, Hispanic, Primary Care, Cultural Congruence

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • New York State Psychiatric Institute - Hispanic Treatment Program

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Culturally congruent assessment and treatment

Usual referral and treatment

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

Entry into specialty mental health care from primary care
Entry into treatment for major depressive disorder after evaluation
Dropout from stepped care

Secondary Outcome Measures

Score on the Hamilton Depression Scale (17-item)
Score on the Clinical Global Impression Scale
Score on the Working Alliance Inventory
Score on the Client Satisfaction Questionnaire
Score on the Side Effects Checklist
Score on the Quality of Life Index
Score on the Social Adjustment Scale - Self-report version
Score on the Client Satisfaction Questionnaire
Score on the Nervios Treatment Scale
Score on the Working Alliance Inventory
Score on the Clinical Global Impression Scale - Patient version

Full Information

First Posted
October 28, 2005
Last Updated
October 24, 2012
Sponsor
New York State Psychiatric Institute
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00247195
Brief Title
Effectiveness of Culturally Based Congruent Care in Treating Hispanics With Major Depressive Disorder
Official Title
Culturally Congruent Care for Hispanic Outpatients With Major Depressive Disorder (MDD)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
August 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
New York State Psychiatric Institute
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Major Depression, MDD, Hispanic, Primary Care, Cultural Congruence

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
113 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Culturally congruent assessment and treatment
Arm Type
Experimental
Arm Description
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).
Arm Title
Usual referral and treatment
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Culturally Congruent Assessment and Treatment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Entry into specialty mental health care from primary care
Time Frame
Measured at study completion
Title
Entry into treatment for major depressive disorder after evaluation
Time Frame
Measured at study completion
Title
Dropout from stepped care
Time Frame
Measured throughout the study
Secondary Outcome Measure Information:
Title
Score on the Hamilton Depression Scale (17-item)
Time Frame
Measured at Week 30
Title
Score on the Clinical Global Impression Scale
Time Frame
Measured at Week 30
Title
Score on the Working Alliance Inventory
Time Frame
Measured at Week 18
Title
Score on the Client Satisfaction Questionnaire
Time Frame
Measured at Week 18
Title
Score on the Side Effects Checklist
Time Frame
Measured at Week 18
Title
Score on the Quality of Life Index
Time Frame
Measured at Week 30
Title
Score on the Social Adjustment Scale - Self-report version
Time Frame
Measured at Week 30
Title
Score on the Client Satisfaction Questionnaire
Time Frame
Measured at Week 30
Title
Score on the Nervios Treatment Scale
Time Frame
Measured at Week 30
Title
Score on the Working Alliance Inventory
Time Frame
Measured at Week 30
Title
Score on the Clinical Global Impression Scale - Patient version
Time Frame
Measured at Week 30

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roberto Lewis-Fernandez, MD
Organizational Affiliation
New York State Psychiatric Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York State Psychiatric Institute - Hispanic Treatment Program
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

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

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