Major Depressive Disorder Clinical Trial
Official title:
Improving the Effectiveness of Treatment for Depression in Hispanics
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.
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.
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