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

NCT ID: NCT00564278

Last Updated: 2021-05-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 217 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-02-29
• Study Completion Date: 2013-08-31

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.

Conditions

Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

Standard antidepressant therapy

Participants will receive standard antidepressant therapy, including selecting among 9 FDA-approved antidepressants from several classes.

Group Type: ACTIVE_COMPARATOR

Standard antidepressant therapy (SADT)

Intervention Type: DRUG

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).

Motivational antidepressant therapy

Participants will receive motivational antidepressant therapy, including selecting among the same list of 9 FDA-approved antidepressants from several classes as in the control arm.

Group Type: EXPERIMENTAL

Standard antidepressant therapy (SADT)

Intervention Type: DRUG

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).

Motivational antidepressant therapy (MADT)

Intervention Type: BEHAVIORAL

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

Interventions

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).

Intervention Type: DRUG

Motivational antidepressant therapy (MADT)

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

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

New York State Psychiatric Institute

OTHER

Sponsor Role: lead

Responsible Party

Roberto Lewis-Fernandez

Professor of Clinical Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Roberto Lewis-Fernandez, MD

Role: PRINCIPAL_INVESTIGATOR

New York State Psychiatric Institute

Locations

New York State Psychiatric Institute, 1051 Riverside Drive

New York, New York, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 25736422 (View on PubMed)

Related Links

https://nyculturalcompetence.org/

Related info

Other Identifiers

R01MH077226

Identifier Type: NIH

Identifier Source: secondary_id

View Link

DSIR 82-SESC

Identifier Type: -

Identifier Source: secondary_id

#5516/#6609R

Identifier Type: -

Identifier Source: org_study_id