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

Completed · Not applicable

Conditions studied: Depression

In brief

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.

Key facts

Study ID

NCT00247195

Run by

New York State Psychiatric Institute

People needed

113

Starts

2005-11-01

Expected to finish

2010-08-01

Last updated by the study team

2012-10-25

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• New York State Psychiatric Institute - Hispanic Treatment Program — New York, New York, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.