Depression Clinical Trial
Official title:
Culturally Congruent Care for Hispanic Outpatients With Major Depressive Disorder (MDD)
Verified date | October 2012 |
Source | New York State Psychiatric Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 113 |
Est. completion date | August 2010 |
Est. primary completion date | August 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | New York State Psychiatric Institute - Hispanic Treatment Program | New York | New York |
Lead Sponsor | Collaborator |
---|---|
New York State Psychiatric Institute | National Institute of Mental Health (NIMH) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Entry into specialty mental health care from primary care | Measured at study completion | No | |
Primary | Entry into treatment for major depressive disorder after evaluation | Measured at study completion | No | |
Primary | Dropout from stepped care | Measured throughout the study | No | |
Secondary | Score on the Hamilton Depression Scale (17-item) | Measured at Week 30 | No | |
Secondary | Score on the Clinical Global Impression Scale | Measured at Week 30 | No | |
Secondary | Score on the Working Alliance Inventory | Measured at Week 18 | No | |
Secondary | Score on the Client Satisfaction Questionnaire | Measured at Week 18 | No | |
Secondary | Score on the Side Effects Checklist | Measured at Week 18 | No | |
Secondary | Score on the Quality of Life Index | Measured at Week 30 | No | |
Secondary | Score on the Social Adjustment Scale - Self-report version | Measured at Week 30 | No | |
Secondary | Score on the Client Satisfaction Questionnaire | Measured at Week 30 | No | |
Secondary | Score on the Nervios Treatment Scale | Measured at Week 30 | No | |
Secondary | Score on the Working Alliance Inventory | Measured at Week 30 | No | |
Secondary | Score on the Clinical Global Impression Scale - Patient version | Measured at Week 30 | No |
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