Incorporating Patient Treatment Choice to Improve Treatment Retention in Depressed Hispanics

Major Depressive Disorder Clinical Trial

Official title:

Improving the Effectiveness of Treatment for Depression in Hispanics

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00742573
• Other study ID #: #5692
• Secondary ID: R01MH076051DSIR
• Status: Completed
• Phase: Phase 2
• Start date: August 2008
• Est. completion date: January 10, 2014

Study information

• Verified date: February 2020
• Source: New York State Psychiatric Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 170
• Est. completion date: January 10, 2014
• Est. primary completion date: January 10, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Drug:
• Antidepressants through Texas Medication Algorithm (TMA)
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.

Behavioral:
• Brief Interpersonal Psychotherapy (IPT-B)
IPT-B consists of twelve 50-minute sessions, divided into three phases, focusing on an interpersonal problem or problems.

Locations

Country	Name	City	State
United States	New York State Psychiatric Institute	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
New York State Psychiatric Institute	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Time of Retention	Average number of weeks of retention of Hispanics in the treatment of MDD	52 weeks
Primary	Hamilton Depression Scale (HAMD-17)	Hamilton Depression Scale (HAMD-17): Scoring is based on the 17-item scale of 0-4, the higher the worse.; 0-7 are considered as being normal, 8-16 suggest mild depression, 17-23 moderate depression, over 24 severe depression; Minimum is 0 and the maximum score being 52	Baseline