Effects of Adding Motivational Interviewing to Antidepressant Treatment for Hispanic Adults With Depression - Full Text View

Sponsored by:	National Institute of Mental Health (NIMH)
Information provided by:	National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:	NCT00564278

Purpose

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

Condition	Intervention
Depression	Drug: Standard antidepressant therapy (SADT) Behavioral: Motivational antidepressant therapy (MADT)

MedlinePlus related topics: Antidepressants Depression

Drug Information available for: Sertraline hydrochloride Sertraline Escitalopram Benzetimide Citalopram Citalopram hydrobromide Dexetimide Escitalopram oxalate Paroxetine Paroxetine hydrochloride Paroxetine Mesylate Bupropion hydrochloride Bupropion Mirtazapine Venlafaxine Venlafaxine hydrochloride Duloxetine Duloxetine hydrochloride Nortriptyline Nortriptyline hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Health Services Research, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Official Title:	Motivational Antidepressant Therapy for Hispanics

Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:

Number of days in ADT (retention) [ Time Frame: Measured at Months 3 and 9 ] [ Designated as safety issue: No ]
HAMD-17 (symptoms) [ Time Frame: Measured at Months 3 and 9 ] [ Designated as safety issue: No ]
Sheehan Disability Scale (impairment) [ Time Frame: Measured at Months 3 and 9 ] [ Designated as safety issue: No ]
Q-LES-Q (quality of life) [ Time Frame: Measured at Months 3 and 9 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Client Satisfaction Questionnaire (patient satisfaction) [ Time Frame: Measured at Months 3 and 9 ] [ Designated as safety issue: No ]
Composite Adherence Score (medication adherence) [ Time Frame: Measured at Months 3 and 9 ] [ Designated as safety issue: No ]

Estimated Enrollment:	240
Study Start Date:	February 2008
Estimated Study Completion Date:	July 2012
Estimated Primary Completion Date:	July 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Participants will receive standard antidepressant therapy	Drug: Standard antidepressant therapy (SADT) Treatment with medication will follow the Texas Medication Algorithm (TMA) for Depression. Antidepressant medications may include the following: citalopram (Celexa), escitalopram (Lexapro), paroxetine (Paxil CR), sertraline (Zoloft), venlafaxine XR (Effexor XR), bupropion SR (Wellbutrin SR), duloxetine (Cymbalta), nortriptyline (Pamelor), and mirtazapine (Remeron).
2: Experimental Participants will receive motivational antidepressant therapy	Behavioral: Motivational antidepressant therapy (MADT) The same medication treatment for depression will be offered and supplemented with techniques from motivational interviewing.

Arms

Assigned Interventions

1: Active Comparator

Participants will receive standard antidepressant therapy

Drug: Standard antidepressant therapy (SADT)

Treatment with medication will follow the Texas Medication Algorithm (TMA) for Depression. Antidepressant medications may include the following: citalopram (Celexa), escitalopram (Lexapro), paroxetine (Paxil CR), sertraline (Zoloft), venlafaxine XR (Effexor XR), bupropion SR (Wellbutrin SR), duloxetine (Cymbalta), nortriptyline (Pamelor), and mirtazapine (Remeron).

2: Experimental

Participants will receive motivational antidepressant therapy

Behavioral: Motivational antidepressant therapy (MADT)

The same medication treatment for depression will be offered and supplemented with techniques from motivational interviewing.

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

Ages Eligible for Study:	18 Years to 79 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Self-identifies as Hispanic
Meets DSM-IV 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 150/90 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 PRN benzodiazepines; 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00564278

Contacts

Contact: Roberto Lewis-Fernandez, MD	212-543-6512	rlewis@nyspi.cpmc.columbia.edu
Contact: Donna Vermes, RN	212-543-6534	donna@nyspi.cpmc.columbia.edu

Locations

United States, New York
New York State Psychiatric Institute, 1051 Riverside Drive #69	Recruiting
New York, New York, United States, 10032
Contact 212-543-5367
Contact: Melissa Rosario 212-543-6514 rosario@nyspi.cpmc.columbia.edu
Principal Investigator: Roberto Lewis-Fernandez, MD
Sub-Investigator: Carlos Blanco, MD, PhD

Sponsors and Collaborators

National Institute of Mental Health (NIMH)

Investigators

Principal Investigator:

Roberto Lewis-Fernandez, MD

New York State Psychiatric Institute

More Information

Responsible Party:	New York State Psychiatric Institute ( Roberto Lewis-Fernandez, MD )
Study ID Numbers:	R01 MH077226, DSIR 82-SESC
Study First Received:	November 26, 2007
Last Updated:	September 18, 2008
ClinicalTrials.gov Identifier:	NCT00564278
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):

Hispanic Americans
Major Depressive Disorder
Antidepressant Therapy

Motivational Interviewing
Treatment Retention
Treatment Adherence

Study placed in the following topic categories:

Depression
Depressive Disorder, Major
Urinary Retention
Depressive Disorder
Mirtazapine
Citalopram
Paroxetine
Duloxetine

Behavioral Symptoms
Mental Disorders
Nortriptyline
Venlafaxine
Bupropion
Mood Disorders
Sertraline
Dexetimide

ClinicalTrials.gov processed this record on January 30, 2009