Overview

This trial is active, not recruiting.

Condition major depressive disorder
Treatments antidepressants through texas medication algorithm (tma), brief interpersonal psychotherapy (ipt-b)
Phase phase 2
Sponsor New York State Psychiatric Institute
Collaborator National Institute of Mental Health (NIMH)
Start date August 2008
End date December 2016
Trial size 170 participants
Trial identifier NCT00742573, #5692, DSIR 83-ATSO, R01MH076051

Summary

This study will determine whether combination treatment driven by patient choice is better than standardized medication treatment at retaining and improving Hispanic patients with major depressive disorder.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
Participants will receive medication treatment according to the Texas Medication Algorithm (TMA) for depression
antidepressants through texas medication algorithm (tma) Celexa
Treatment with medication will follow the TMA for depression. Antidepressant medications may include any of the following: citalopram, escitalopram, paroxetine, sertraline, venlafaxine XR, bupropion SR, duloxetine, nortriptyline, and mirtazapine.
(Experimental)
Participants will be offered brief interpersonal psychotherapy (IPT-B) alone or combined with the TMA for depression
antidepressants through texas medication algorithm (tma) Celexa
Treatment with medication will follow the TMA for depression. Antidepressant medications may include any of the following: citalopram, escitalopram, paroxetine, sertraline, venlafaxine XR, bupropion SR, duloxetine, nortriptyline, and mirtazapine.
brief interpersonal psychotherapy (ipt-b)
IPT-B consists of twelve 50-minute sessions, divided into three phases, focusing on an interpersonal problem or problems.

Primary Outcomes

Measure
Retention in evidence-based treatment
time frame: Measured at 3 months and 1 year
Hamilton Depression Scale (HAMD-17)
time frame: Measured at baseline and at Weeks -1, 4, 8, 12, 16, 24, 32, 40, 48, and 52

Secondary Outcomes

Measure
Treatment Adherence and Retention Questionnaire (TARQ)
time frame: Measured at baseline and at Weeks 12, 24, and 52
Client Satisfaction Questionnaire (CSQ)
time frame: Measured at baseline and at Weeks 4, 8, 12, 16, 24, 32, 40, 48, and 52
Perceived Need for Care Questionnaire (PNCQ)
time frame: Measured at baseline and at Weeks 4, 8, 12, 16, 24, 32, 40, 48, and 52
Sheehan Disability Scale (SDS)
time frame: Measured at baseline and at Weeks 4, 8, 12, 16, 24, 32, 40, 48, and 52
Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)
time frame: Measured at baseline and at Weeks 4, 8, 12, 16, 24, 32, 40, 48, and 52

Eligibility Criteria

Male or female participants from 18 years up to 79 years old.

Inclusion Criteria: - Hispanic males and females - DSM-IV criteria for non-psychotic major depressive disorder (MDD) of at least moderate severity (HAM-D-17> 18) - 18- 79 - Patients with stable dosage of Benzodiazepines to treat anxiety disorders Exclusion Criteria: - At risk of attempting suicide - Unstable medical illness - History of bipolar disorder, schizophrenia, or other psychotic disorder - Pregnant or lactating - Alcohol or substance use disorder that requires acute detoxification

Additional Information

Official title Improving the Effectiveness of Treatment for Depression in Hispanics
Principal investigator Carlos Blanco, MD, PhD
Description Retention of Hispanics in the treatment of major depressive disorder (MDD) continues to be a major public health problem. Hispanics drop out from treatment two to three times more frequently than non-Hispanic whites, despite the scarcity of treatment alternatives for Hispanics and their low rates of re-entry into the mental health care system. Consistent with the goals of Healthy People 2010 and the President's New Freedom Commission on Mental Health, the goal of this study is to test the efficacy in a research setting of a novel intervention to improve retention and response. This efficacy assessment would serve as a reference point for the development of future effectiveness trials in community settings. Our intervention is founded on growing evidence that when depressed Hispanics seek help for mental health problems, they prefer to receive psychotherapy or combined treatment in the form of weekly in-person clinic visits. However, socioeconomic barriers, such as low-paying jobs with irregular hours, lack of child care, and limited time availability, often reduce treatment retention and result in dropout rates up to three times those of non-Hispanic whites. Based on emerging literature and on promising pilot data, we propose to study the efficacy for depressed Hispanics of an intervention that would allow for patient choice between the following options: 1) Medication alone, following the Texas Medication Algorithm for Depression (TMA); 2) Brief Interpersonal Psychotherapy (IPT-B) alone, with optional telephone sessions; or 3) Combined medication plus IPT-B. This intervention would allow switching of treatment modality (e.g., from IPT-B alone to combined treatment) at any point during the study period. We hypothesize that by permitting patient choice among evidence-based treatments, flexibility in the sequential use of treatments, and novel treatment delivery systems, this intervention will substantially increase retention of Hispanics in MDD treatment. Furthermore, we will examine mediators and moderators of retention, including stigma and insurance coverage. We propose to test this intervention in depressed Hispanics seeking outpatient psychiatric treatment using a randomized trial with TMA as the control group. Both groups will have access to medication using the TMA but only one group will be offered IPT_B. . We will test the association between treatment, retention, and response over the course of acute MDD care (12 weeks), and will also obtain preliminary outcome data after 9 more months of treatment (i.e., for a total of 12 months). Our pilot data enable us to estimate the sample size for the acute phase, while the additional follow-up period allows us to examine the effect of choice over the longer-term course of MDD care.
Trial information was received from ClinicalTrials.gov and was last updated in December 2014.
Information provided to ClinicalTrials.gov by New York State Psychiatric Institute.