Status:
COMPLETED
Effectiveness of Culturally Based Congruent Care in Treating Hispanics With Major Depressive Disorder
Lead Sponsor:
New York State Psychiatric Institute
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Depression
Eligibility:
All Genders
18-80 years
Phase:
NA
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 Hispan...
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 wer...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2010
Estimated Enrollment :
113 Patients enrolled
Trial Details
Trial ID
NCT00247195
Start Date
November 1 2005
End Date
August 1 2010
Last Update
October 25 2012
Active Locations (1)
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1
New York State Psychiatric Institute - Hispanic Treatment Program
New York, New York, United States, 10032