Incorporating Patient Treatment Choice to Improve Treatment Retention in Depressed Hispanics
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 2

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.
    

Detailed 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.
    

Intervention name(s): Antidepressants through Texas Medication Algorithm (TMA); Brief Interpersonal Psychotherapy (IPT-B)
Intervention type(s): Drug; Behavioral
Intervention description(s): 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.; IPT-B consists of twelve 50-minute sessions, divided into three phases, focusing on an interpersonal problem or problems.
Other intervention name(s): Celexa; Lexapro; Paxil; Zoloft; Effexor XR; Wellbutrin; Cymbalta; Pamelor; Remeron
Intervention MeSH terms: Antidepressive Agents; Bupropion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Major Depressive Disorder; Mood Disorders; Hispanic