Clinical trial NCT00742573: Incorporating Patient Treatment Choice to Improve Treatment Retention in Depressed Hispanics
Official title: Improving the Effectiveness of Treatment for Depression in Hispanics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Major Depressive Disorder
Keywords: Major Depressive Disorder
Mood Disorders
Hispanic
Lead sponsor: New York State Psychiatric Institute
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2008-08-27
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Mean Time of Retention
timeFrame: 52 weeks
measure: Hamilton Depression Scale (HAMD-17)
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York State Psychiatric Institute
state: New York
Study officials:
affiliation: New York State Psychiatric Institute
name: Carlos Blanco, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Blanco C, Markowitz JC, Hellerstein DJ, Nezu AM, Wall M, Olfson M, Chen Y, Levenson J, Onishi M, Varona C, Okuda M, Hershman DL. A randomized trial of interpersonal psychotherapy, problem solving therapy, and supportive therapy for major depressive disorder in women with breast cancer. Breast Cancer Res Treat. 2019 Jan;173(2):353-364. doi: 10.1007/s10549-018-4994-5. Epub 2018 Oct 20.