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Comparative Effectiveness Research for Eliminating Disparities (CERED)

2016年6月2日 更新者:Margarita Alegria, PhD、Massachusetts General Hospital

UPR-CHA Research Center of Excellence- Supplement

Our study tested the effectiveness of a combined cognitive behavioral therapy (CBT) and care manager intervention offered either by telephone or face-to-face with depressed Latinos identified in primary care. Eligible patients were randomized after baseline to one of three conditions; 1) ECLA-T (telephone) intervention, 2) ECLA-F (face to face) intervention, and 3) usual care. Usual care was considered care as usual in the participating clinic for a patient screening or depression. The ECLA-T intervention was based on a telephone-plus-care-management intervention that has been shown to be effective in decreasing depressive symptoms and increasing client satisfaction and self-perceived global improvement, as compared to usual care in depressed patients in primary care settings.

研究概览

详细说明

Our study tested the effectiveness of a combined cognitive behavioral therapy (CBT) and care manager intervention offered either by telephone or face-to-face with depressed Latinos identified in primary care. The study was conducted at two sites (San Juan, PR and Boston, MA), each of which had multiple clinics. Eligible patients were randomized after baseline to one of three conditions; 1) ECLA-T (telephone) intervention, 2) ECLA-F (face to face) intervention, and 3) usual care. Usual care was considered care as usual in the participating clinic for a patient screening or depression. The ECLA-T intervention was based on a telephone-plus-care-management intervention that has been shown to be effective in decreasing depressive symptoms and increasing client satisfaction and self-perceived global improvement, as compared to usual care in depressed patients in primary care settings.

All participants received a baseline interview assessment prior to randomization. After treatment completion (2 to 3 months from baseline), patients completed an end-of-treatment (EOT) assessment, including repeated assessment of baseline measurements. A 4-month follow-up from baseline was scheduled, which replicated the EOT assessment.

For those patients in the intervention conditions, during each session the clinician used CBT and motivational enhancement strategies to engage the patient in treatment and enhance retention. The CBT intervention was composed of a shortened version of the original CBT intervention, comprised of modules that focus on identifying and correcting negative distortions or cognitions, promote behavioral activation through engaging the patient in pleasant activities, and develop supportive relationships. All sessions were tailored within the structured format considering the patient's needs and always employed a collaborative approach with the patient.

The first four sessions occurred weekly. Every other week the clinician evaluated the patient with the PHQ-9 to determine the level of depressive symptoms. After four sessions, if there was improvement two to four more bi-weekly sessions were scheduled. If there was no or minimal improvement, sessions continued weekly up to a total of 8 sessions for a maximum of 3 months treatment. Cases that showed no improvement or deterioration received more intensive monitoring from the supervising clinicians at both sites.

研究类型

介入性

注册 (实际的)

257

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • San Juan、波多黎各、00936
        • University of Puerto Rico
    • Massachusetts
      • Somerville、Massachusetts、美国、02134
        • Cambridge Health Alliance

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Patients are eligible if they are Latinos, at least 18 years of age, score 10 or more on the PHQ-9 and meet at least one of the essential criteria for Major Depressive Disorder (MDD).

Exclusion Criteria:

  • Exclusion criteria include history of psychosis, use of any specialty mental health treatment within the 3 months prior to baseline or an appointment with a mental health provider within the next two months, inability to demonstrate capacity to consent or evidence of suicidal thoughts or ideation as measured by an affirmative response to questions 4 and 5 on the Paykel Suicide Questionnaire).

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
有源比较器:Engagement and Counseling for Latinos (ECLA-F)
Patients in this arm (ECLA-F) receive the 6-8 session CBT plus care-management intervention, administered in person.
The Engagement and Counseling for Latinos - Face-to-face (ECLA-F) intervention is a cognitive behavioral therapy (CBT) plus care-management intervention delivered in person. The CBT component consists of 6-8 sessions, delivered by a Master's level clinician, and focusing on self-management techniques, problem-solving, and techniques for managing depression and stress. The care-management component of the intervention consisted of monitoring, assistance in scheduling appointments, and help with transportation. This intervention was identical to the telephone (ECLA-F) intervention, except for the delivery method.
有源比较器:Engagement and Counseling for Latinos (ECLA-T)
Patients in this arm received the 6-8 session CBT intervention via telephone.
The Engagement and Counseling for Latinos - Telephone (ECLA-T) intervention is a cognitive behavioral therapy (CBT) plus care-management intervention delivered via telephone. The CBT component consists of 6-8 sessions, delivered by a Master's level clinician, and focusing on self-management techniques, problem-solving, and techniques for managing depression and stress. The care-management component of the intervention consisted of monitoring, assistance in scheduling appointments, and technical assistance. This intervention was identical to the face-to-face (ECLA-F) intervention, except for the delivery method.
无干预:Usual Care
Patients in this arm receive usual care for depression from their primary care providers, which could include antidepressant prescription or referral to specialty mental health care.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Change in Depression Severity at baseline, end of treatment (2-3 months), and 6-month follow-up
大体时间:Baseline, At each intervention visit (approximately weekly up to end of treatment at 2-3 months), and at 6-month follow-up
Change in severity of depression symptoms will be assessed using two different measures. The Patient Health Questionnaire-9 (PHQ-9) is a nine item depression screening tool, developed and validated for use in primary care settings. The Hopkins Symptom Checklist-20 (HSCL-20) measures depression symptom severity and distress.
Baseline, At each intervention visit (approximately weekly up to end of treatment at 2-3 months), and at 6-month follow-up

次要结果测量

结果测量
措施说明
大体时间
Change in Past 30-day Functioning at baseline, end of treatment (2-3 months), and 6-month follow-up
大体时间:Baseline, At each intervention visit (approximately weekly up to end of treatment at 2-3 months), and at 6-month follow-up
Overall functioning over the past 30 days was measured using the World Health Organization Disability Assessment Schedule 2.0 (WHO-DAS 2.0).
Baseline, At each intervention visit (approximately weekly up to end of treatment at 2-3 months), and at 6-month follow-up

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Margarita Alegria, Ph.D.、Cambridge Health Alliance
  • 首席研究员:Glorisa Canino, Ph.D.、University of Puerto Rico

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

有用的网址

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2011年5月1日

初级完成 (实际的)

2012年9月1日

研究完成 (实际的)

2012年9月1日

研究注册日期

首次提交

2013年12月18日

首先提交符合 QC 标准的

2014年1月2日

首次发布 (估计)

2014年1月6日

研究记录更新

最后更新发布 (估计)

2016年6月3日

上次提交的符合 QC 标准的更新

2016年6月2日

最后验证

2016年6月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • CHA-IRB-0465/08/10
  • 3P60MD002261 (美国 NIH 拨款/合同)

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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