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
  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)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Motivational Antidepressant Therapy for Hispanics

Resource links provided by NLM:


Further study details as provided by New York State Psychiatric Institute:

Primary Outcome Measures:
  • 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 ]

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: 230
Study Start Date: February 2008
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
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).
Experimental: 2
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 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
  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.columbia.edu
Contact: Donna Vermes, NP 212-543-6534 donna@nyspi.columbia.edu

Locations
United States, New York
New York State Psychiatric Institute, 1051 Riverside Drive Recruiting
New York, New York, United States, 10032
Contact: Anxiety Disorders Clinic    212-543-5367      
Contact: Sylvanna Vargas    212-543-5626    vargass@nyspi.columbia.edu   
Principal Investigator: Roberto Lewis-Fernandez, MD         
Sub-Investigator: Carlos Blanco, MD, PhD         
Sponsors and Collaborators
New York State Psychiatric Institute
Investigators
Principal Investigator: Roberto Lewis-Fernandez, MD New York State Psychiatric Institute
  More Information

Additional Information:
No publications provided

Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT00564278     History of Changes
Other Study ID Numbers: #5516/#6609R, R01MH077226, DSIR 82-SESC
Study First Received: November 26, 2007
Last Updated: August 16, 2013
Health Authority: United States: Federal Government

Keywords provided by New York State Psychiatric Institute:
Hispanic Americans
Major Depressive Disorder
Antidepressant Therapy
Motivational Interviewing
Treatment Retention
Treatment Adherence

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014