Effects of Adding Motivational Interviewing to Antidepressant Treatment for Hispanic Adults With Depression

This study is currently recruiting participants.
Verified October 2012 by New York State Psychiatric Institute
Sponsor:
Collaborator:
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT00564278
First received: November 26, 2007
Last updated: August 16, 2013
Last verified: October 2012

November 26, 2007
August 16, 2013
February 2008
August 2013   (final data collection date for primary outcome measure)
  • Number of days in ADT (retention) [ Time Frame: Measured at Months 3 and 9 ] [ Designated as safety issue: No ]
  • Hamilton Depression Scale -17-item version (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 ]
  • Perceived quality of life [ Time Frame: Measured at Months 3 and 9 ] [ Designated as safety issue: No ]
  • Number of days in ADT (retention) [ Time Frame: Measured at Months 4 and 10 ]
  • HAMD-17 (symptoms) [ Time Frame: Measured at Months 4 and 10 ]
  • Sheehan Disability Scale (impairment) [ Time Frame: Measured at Months 4 and 10 ]
  • Q-LES-Q (quality of life) [ Time Frame: Measured at Months 4 and 10 ]
Complete list of historical versions of study NCT00564278 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Client Satisfaction Questionnaire (patient satisfaction) [ Time Frame: Measured at Months 4 and 10 ]
  • Composite Adherence Score (medication adherence) [ Time Frame: Measured at Months 4 and 10 ]
Not Provided
Not Provided
 
Effects of Adding Motivational Interviewing to Antidepressant Treatment for Hispanic Adults With Depression
Motivational Antidepressant Therapy for Hispanics

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

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Health Services Research
Depression
  • 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).
  • Behavioral: Motivational antidepressant therapy (MADT)
    The same medication treatment for depression will be offered and supplemented with techniques from motivational interviewing.
  • Active Comparator: 1
    Participants will receive standard antidepressant therapy
    Intervention: Drug: Standard antidepressant therapy (SADT)
  • Experimental: 2
    Participants will receive motivational antidepressant therapy
    Intervention: Behavioral: Motivational antidepressant therapy (MADT)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
230
August 2013
August 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 79 Years
No
Contact: Roberto Lewis-Fernandez, MD 212-543-6512 rlewis@nyspi.columbia.edu
Contact: Donna Vermes, NP 212-543-6534 donna@nyspi.columbia.edu
United States
 
NCT00564278
#5516/#6609R, R01MH077226, DSIR 82-SESC
No
New York State Psychiatric Institute
New York State Psychiatric Institute
National Institute of Mental Health (NIMH)
Principal Investigator: Roberto Lewis-Fernandez, MD New York State Psychiatric Institute
New York State Psychiatric Institute
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP