Clinical trial NCT00564278: Effects of Adding Motivational Interviewing to Antidepressant Treatment for Hispanic Adults With Depression
Official title: Motivational Antidepressant Therapy for Hispanics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: Hispanic Americans
Major Depressive Disorder
Antidepressant Therapy
Motivational Interviewing
Treatment Retention
Treatment Adherence
Lead sponsor: New York State Psychiatric Institute
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2007-11-27
Enrollment: 217
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study will evaluate the effectiveness of adding motivational interviewing to antidepressant treatment for major depressive disorder in Hispanic adults.

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 being one of the most common. The following symptoms may be signs of major depression: 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 major depression 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 major depression.

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 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

Primary outcomes:
measure: Number of Days in ADT (Retention)
timeFrame: Measured at Months 3 and 9
measure: Mean of Depressive Symptoms Over 36-week Follow-up Using Hamilton Depression Scale -17-item Version (Symptoms)
timeFrame: HAMD-17 assessed at follow-up weeks 2, 4, 8, 12, 20, 28, and 36.
measure: Mean Disability Over 36-week Follow-up Using Sheehan Disability Scale (Impairment)
timeFrame: SDS at follow-up weeks 2, 4, 8, 12, 20, 28, and 36.
measure: Mean Perceived Quality of Life Over 36-week Follow-up Using Quality of Life Enjoyment and Satisfaction Questionnaire (QLESQ)
timeFrame: QLESQ at follow-up weeks 2, 4, 8, 12, 20, 28, and 36.
Secondary outcomes:
measure: Mean Patient Satisfaction Over 36-week Follow-up Using Client Satisfaction Questionnaire (CSQ)
timeFrame: CSQ at follow-up weeks 2, 4, 8, 12, 20, 28, and 36.
measure: Proportion of Fully Adherent Days
timeFrame: Measured at each visit, up to 36 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: New York State Psychiatric Institute, 1051 Riverside Drive
state: New York
Study officials:
affiliation: New York State Psychiatric Institute
name: Roberto Lewis-Fernandez, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vargas SM, Cabassa LJ, Nicasio A, De La Cruz AA, Jackson E, Rosario M, Guarnaccia PJ, Lewis-Fernandez R. Toward a cultural adaptation of pharmacotherapy: Latino views of depression and antidepressant therapy. Transcult Psychiatry. 2015 Apr;52(2):244-73. doi: 10.1177/1363461515574159. Epub 2015 Mar 3.