Effects of Adding Motivational Interviewing to Antidepressant Treatment for Hispanic Adults With Depression
Information source: New York State Psychiatric Institute
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Depression
Intervention: Standard antidepressant therapy (SADT) (Drug); Motivational antidepressant therapy (MADT) (Behavioral)
Phase: N/A
Status: Completed
Sponsored by: New York State Psychiatric Institute Official(s) and/or principal investigator(s): Roberto Lewis-Fernandez, MD, Principal Investigator, Affiliation: New York State Psychiatric Institute
Summary
This study will evaluate the effectiveness of adding motivational interviewing to
antidepressant treatment for major depressive disorder in Hispanic adults.
Clinical Details
Official title: Motivational Antidepressant Therapy for Hispanics
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Health Services Research
Primary outcome: Number of days in ADT (retention)Hamilton Depression Scale -17-item version (symptoms) Sheehan Disability Scale (impairment) Perceived quality of life
Secondary outcome: Client Satisfaction Questionnaire (patient satisfaction)Composite Adherence Score (medication adherence)
Detailed description:
Depression is a serious illness that affects a person's mood, thoughts, and physical
well-being. There are multiple types of depressive disorders, with major depressive
disorder (MDD) being one of the most common. The following symptoms may be signs of MDD:
persistent feelings of anxiety, guilt, or hopelessness; irregular sleep and appetite
patterns; lethargy; disinterest in previously enjoyed activities; excessive irritability and
restlessness; suicidal thoughts; and inability to concentrate. Despite the widespread use of
drug treatment for MDD in the United States, it continues to be underutilized in the
Hispanic population. The retention rate in antidepressant therapy (ADT) among the Hispanic
population is half that of the Caucasian population. It is believed that cultural factors
and ambivalence toward seeking treatment interfere with ADT retention in Hispanic adults.
Motivational antidepressant therapy (MADT) involves the use of motivational interviewing
(MI) to discuss treatment with patients. This study will compare the effectiveness of
culturally-specific MADT versus standard antidepressant therapy (SADT) in treating Hispanic
adults with MDD.
Participants in this single-blind study will be randomly assigned to receive either MADT or
SADT. A psychiatrist will conduct all medication visits and will recommend an initial
antidepressant for each participant. Depending on treatment assignment, psychiatrists will
use either the MADT or SADT approach in the medication visits. During the visits,
participants will complete questionnaires, undergo vital sign measurements, and receive
medication. Medication visits will occur weekly during the first two weeks, every 2 weeks
for the next 6 weeks, and then on a monthly basis until the end of the study. In addition to
visits with the psychiatrist, participants will complete 15-minute individual interviews
with a clinician from the Hispanic Treatment Program. Individual interviews will take place
every 2 weeks in the first month of treatment, monthly until the third month, and then every
other month thereafter. The association between treatment, retention, and response will be
assessed after 3 months of treatment. Preliminary outcome data will be obtained after 6 more
months of continued treatment. After the end of treatment, participants may randomly be
asked to participate in a small "focus group" to discuss personal experiences with study
treatments.
Eligibility
Minimum age: 18 Years.
Maximum age: 79 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Self-identifies as Hispanic
- Meets Diagnostic and Statistical Manual, 4th edition criteria for major depressive
disorder (MDD)
- Score of 16 or higher on Hamilton Depression Scale (HAM-D17) at study entry
- Willing to abstain from other psychotropic medications not included in the Texas
Medication Algorithm (TMA) for depression, as clinically indicated, for the duration
of the study. Zolpidem for insomnia will be allowed.
- Fluency in English or Spanish
Exclusion Criteria:
- Acute suicidality
- History of schizophrenia, bipolar affective disorder, schizoaffective disorder,
depression with psychotic features, or organic brain syndromes
- Alcohol or other substance abuse or dependence (except nicotine) within 6 months
prior to study entry
- Clinically unstable medical disease, including narrow-angle glaucoma or increased
intra-ocular pressure
- Systemic blood pressure of 140/90 mm Hg or less
- Liver function test values two times above the normal level
- Pregnant or breastfeeding
- Sexually active women not using an effective method of birth control
- Current or past history of seizure disorder (except febrile seizure in childhood)
- Receiving effective medication for MDD
- Unable to tolerate or unwilling to accept drug-free period of varying length: 1 week
for benzodiazepines taken as needed; 2 weeks for buspirone, lithium, anticonvulsants,
stimulants, barbiturates, opiates, and regular-use benzodiazepines (except
clonazepam); and 5 weeks for clonazepam
- Received electroconvulsive therapy (ECT) within 3 months prior to study entry
- Parkinson's disease, dementia of any type, or cognitive impairment
Locations and Contacts
New York State Psychiatric Institute, 1051 Riverside Drive, New York, New York 10032, United States
Additional Information
Related info
Starting date: February 2008
Last updated: September 2, 2014
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