search
Back to results

Incorporating Patient Treatment Choice to Improve Treatment Retention in Depressed Hispanics

Primary Purpose

Major Depressive Disorder

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Antidepressants through Texas Medication Algorithm (TMA)
Brief Interpersonal Psychotherapy (IPT-B)
Sponsored by
New York State Psychiatric Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring Major Depressive Disorder, Mood Disorders, Hispanic

Eligibility Criteria

18 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • New York State Psychiatric Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

1 Texas Medication Algorithm

2 Patient Choice

Arm Description

Participants will receive medication treatment according to the Texas Medication Algorithm (TMA) for depression

Participants will be offered brief interpersonal psychotherapy (IPT-B) alone or combined with the TMA for depression

Outcomes

Primary Outcome Measures

Mean Time of Retention
Average number of weeks of retention of Hispanics in the treatment of MDD
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

Secondary Outcome Measures

Full Information

First Posted
August 25, 2008
Last Updated
February 20, 2020
Sponsor
New York State Psychiatric Institute
Collaborators
National Institute of Mental Health (NIMH)
search

1. Study Identification

Unique Protocol Identification Number
NCT00742573
Brief Title
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

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
January 10, 2014 (Actual)
Study Completion Date
January 10, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
New York State Psychiatric Institute
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
Major Depressive Disorder, Mood Disorders, Hispanic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
170 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1 Texas Medication Algorithm
Arm Type
Active Comparator
Arm Description
Participants will receive medication treatment according to the Texas Medication Algorithm (TMA) for depression
Arm Title
2 Patient Choice
Arm Type
Experimental
Arm Description
Participants will be offered brief interpersonal psychotherapy (IPT-B) alone or combined with the TMA for depression
Intervention Type
Drug
Intervention Name(s)
Antidepressants through Texas Medication Algorithm (TMA)
Other Intervention Name(s)
Celexa, Lexapro, Paxil, Zoloft, Effexor XR, Wellbutrin, Cymbalta, Pamelor, Remeron
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Brief Interpersonal Psychotherapy (IPT-B)
Intervention Description
IPT-B consists of twelve 50-minute sessions, divided into three phases, focusing on an interpersonal problem or problems.
Primary Outcome Measure Information:
Title
Mean Time of Retention
Description
Average number of weeks of retention of Hispanics in the treatment of MDD
Time Frame
52 weeks
Title
Hamilton Depression Scale (HAMD-17)
Description
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
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carlos Blanco, MD, PhD
Organizational Affiliation
New York State Psychiatric Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York State Psychiatric Institute
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to make individual participant available to other researchers at this time.
Citations:
PubMed Identifier
30343455
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.
Results Reference
derived

Learn more about this trial

Incorporating Patient Treatment Choice to Improve Treatment Retention in Depressed Hispanics

We'll reach out to this number within 24 hrs