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临床试验/NCT00742573
NCT00742573已完成2 期

Improving the Effectiveness of Treatment for Depression in Hispanics

New York State Psychiatric Institute1 个研究点 分布在 1 个国家目标入组 170 人开始时间: 2008年8月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
170
试验地点
1
主要终点
Mean Time of Retention

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 79 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Hispanic males and females
  • DSM-IV criteria for non-psychotic major depressive disorder (MDD) of at least moderate severity (HAM-D-17> 18)
  • Patients with stable dosage of Benzodiazepines to treat anxiety disorders

排除标准

  • 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

研究组 & 干预措施

1 Texas Medication Algorithm

Active Comparator

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

干预措施: Antidepressants through Texas Medication Algorithm (TMA) (Drug)

2 Patient Choice

Experimental

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

干预措施: Antidepressants through Texas Medication Algorithm (TMA) (Drug)

2 Patient Choice

Experimental

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

干预措施: Brief Interpersonal Psychotherapy (IPT-B) (Behavioral)

结局指标

主要结局

Mean Time of Retention

时间窗: 52 weeks

Average number of weeks of retention of Hispanics in the treatment of MDD

Hamilton Depression Scale (HAMD-17)

时间窗: Baseline

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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mark Olfson

Research Scientist

New York State Psychiatric Institute

研究点 (1)

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