DepressionNCT00247195
Effectiveness of Culturally Based Congruent Care in Treating Hispanics With Major Depressive Disorder
A study testing Culturally Congruent Assessment and Treatment in people with Depression, run by New York State Psychiatric Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Depression
- What is being tested?
- Culturally Congruent Assessment and Treatment
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 113 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2005to Aug 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 19Show fewer
- 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
Who cannot join
- 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:
Show all 19Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
New York State Psychiatric Institute - Hispanic Treatment Program
New York, New York, 10032
About this study
Official title: Culturally Congruent Care for Hispanic Outpatients With Major Depressive Disorder (MDD)
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.
Read the 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.
- Conditions
- Depression
- Being tested
- Culturally Congruent Assessment and Treatment
- Keywords
- Major Depression, MDD, Hispanic, Primary Care, Cultural Congruence
- Medical subject headings
- Depression, Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Culturally Congruent Assessment and TreatmentBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Behavioral: Culturally Congruent Assessment and Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Entry into specialty mental health care from primary care
Measured: Measured at study completion
Entry into treatment for major depressive disorder after evaluation
Measured: Measured at study completion
Dropout from stepped care
Measured: Measured throughout the study
Secondary outcomes (11)
Score on the Hamilton Depression Scale (17-item)
Measured: Measured at Week 30
Score on the Clinical Global Impression Scale
Measured: Measured at Week 30
Score on the Working Alliance Inventory
Measured: Measured at Week 18
Score on the Client Satisfaction Questionnaire
Measured: Measured at Week 18
Score on the Side Effects Checklist
Measured: Measured at Week 18
Score on the Quality of Life Index
Measured: Measured at Week 30
Score on the Social Adjustment Scale - Self-report version
Measured: Measured at Week 30
Score on the Client Satisfaction Questionnaire
Measured: Measured at Week 30
Score on the Nervios Treatment Scale
Measured: Measured at Week 30
Score on the Working Alliance Inventory
Measured: Measured at Week 30
Score on the Clinical Global Impression Scale - Patient version
Measured: Measured at Week 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2005 (estimated)
- Study startNov 2005
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Roberto Lewis-Fernandez, MD, Principal investigator, New York State Psychiatric Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00247195
- Sponsor's protocol ID
- #4985
- Other IDs
- R34MH073087, DSIR 82-SESC
- Status last verified
- Oct 2012
- First submitted
- 28 Oct 2005
- Last updated
- 25 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Culturally Congruent Care for Hispanic Outpatients With Major Depressive Disorder (MDD)
- ClinicalTrials.gov ID
- NCT00247195
- Acronym / sponsor ID
- #4985
- Conditions
- Depression
- Keywords
- Major Depression, MDD, Hispanic, Primary Care, Cultural Congruence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Nov 2005
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 1 Nov 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Culturally congruent assessment and treatment | Experimental | Behavioral: Culturally Congruent Assessment and TreatmentOutreach 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 and treatment | Active comparator | Behavioral: Culturally Congruent Assessment and TreatmentUsual 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- 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
- Self-identifies as Hispanic
- Family member of a patient with MDD who participated in the previous study (WH-PCDP)
Key exclusion criteria (19 listed)
- 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
- Comorbid medical or psychiatric conditions that may prevent focus group participation (e.g., substance use disorders, psychosis, unstable medical conditions)
- Pre-Engagement Phase
- Declines referral by a primary care physician to specialized mental health services
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Culturally Congruent Assessment and TreatmentReferral, 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. | Behavioural | Culturally congruent assessment and treatment, Usual referral and treatment |
Primary outcome
Entry into specialty mental health care from primary care
Time frame: Measured at study completion
Entry into treatment for major depressive disorder after evaluation
Time frame: Measured at study completion
Dropout from stepped care
Time frame: Measured throughout the study
11 secondary outcomes
Score on the Hamilton Depression Scale (17-item)
Time frame: Measured at Week 30
Score on the Clinical Global Impression Scale
Time frame: Measured at Week 30
Score on the Working Alliance Inventory
Time frame: Measured at Week 18
Score on the Client Satisfaction Questionnaire
Time frame: Measured at Week 18
Score on the Side Effects Checklist
Time frame: Measured at Week 18
Score on the Quality of Life Index
Time frame: Measured at Week 30
Score on the Social Adjustment Scale - Self-report version
Time frame: Measured at Week 30
Score on the Client Satisfaction Questionnaire
Time frame: Measured at Week 30
Score on the Nervios Treatment Scale
Time frame: Measured at Week 30
Score on the Working Alliance Inventory
Time frame: Measured at Week 30
Score on the Clinical Global Impression Scale - Patient version
Time frame: Measured at Week 30
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2012.
Related trials for Depression
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Recruiting
Cultural Adaptation of an Online Parenting Intervention to Reduce the Risk of Depression and Anxiety in Adolescents
Risk of Depression and Anxiety
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roberto Lewis-Fernandez, MD principal investigator
New York State Psychiatric Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Culturally Congruent Assessment and Treatment in people with Depression, run by New York State Psychiatric Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Entry into specialty mental health care from primary care (time frame: Measured at study completion). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2012; AzTrials last refreshed its copy on 7 Nov 2026.