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临床试验/NCT01958840
NCT01958840已完成不适用

Evaluating Behavioral Activation Efficacy in Depressed Spanish-Speaking Latinos

University of Maryland, College Park2 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2013年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
46
试验地点
2
主要终点
Beck Depression Inventory- II

研究概览

简要总结

Following a small, open-label pilot study that yielded very promising results of BATD, the current study will consist of a larger, randomized control trial (n=60) that will compare BATD to Supportive Counseling in outcomes of depression, contact with positive reinforcement in the environment, treatment satisfaction, therapeutic alliance, and perceived stigma. In addition, participants' adherence rates to each of the therapies and their maintenance of clinical gains at a 1-month follow-up, will be examined.

详细描述

Major Depressive Disorder (MDD) is highly prevalent and widely-impairing across racial and ethnic groups. Higher rates of MDD have been observed among Latinos with limited English-language proficiency relative to the general population. Although MDD is a highly treatable condition, barriers to treatment access and delivery have been implicated in precluding this group from utilizing and receiving mental health services. Fortunately, Latinos tend to endorse positive attitudes toward psychosocial treatments for depression by applying the valued belief of "poner de su parte" or being able to do their part in one's recovery, a concept that is highly consistent with the framework of behavioral treatments for depression.

The Behavioral Activation Treatment for Depression (BATD), based on reinforcement theory, may be well-equipped to address disparities associated with higher depression prevalence rates and receipt of care among Latinos with limited English-language proficiency. Following a small, open-label pilot study that yielded very promising results of BATD, the current study will consist of a larger, randomized control trial (N = 60) that will compare BATD to Supportive Counseling in outcomes of depression, activity level, and contact with positive reinforcement in the environment.

Initial eligibility will be determined via a telephone screener, which will include questions from the Mood Disorders, Substance Use and Dependence, and Psychotic Disorders modules of the Structured Clinical Interview for DSM-IV-TR (SCID-IV; First, Spitzer, Gibbon & Williams, 2002).

Inclusion criteria consist of the following: 1) be a minimum of 18 years of age, 2) be of Latino descent, 3) report limited English language proficiency, 4) meet current MDD criteria, 5) have completed the 4th grade or higher either in their country of origin or in the US, 6) not have current substance abuse or dependence, 7) have no Bipolar or Psychotic Disorders, and 9) not be currently receiving psychotherapy, and 10) if currently taking antidepressants, demonstrate pharmacological stability as indicated by 3 or more consecutive months of use. Excluded individuals will be referred to mental health resources within the community.

研究设计

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

入排标准

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

入选标准

  • be a minimum of 18 years of age
  • be of Latino descent
  • report limited English language proficiency
  • meet current MDD criteria
  • have completed the 4th grade or higher either in their country of origin or in the US
  • not have current substance abuse or dependence
  • have no Bipolar or Psychotic Disorders
  • not be currently receiving psychotherapy
  • if currently taking antidepressants, demonstrate pharmacological stability as indicated by 3 or more consecutive months of use.

排除标准

  • 未提供

结局指标

主要结局

Beck Depression Inventory- II

时间窗: Assessed at every session and at the 1-month follow-up

次要结局

  • Behavioral Activation for Depression Scale(Administered at each session and at the 1-month follow-up)

研究者

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

Joe Smith

Director - HRPP (A. Collado is no longer at UMD)

University of Maryland, College Park

研究点 (2)

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