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临床试验/NCT01566318
NCT01566318已完成不适用

Depression Agency-Based Collaborative (Depression ABC)

University of Pittsburgh2 个研究点 分布在 1 个国家目标入组 104 人开始时间: 2012年3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
104
试验地点
2
主要终点
Major depressive disorder

研究概览

简要总结

Seniors who receive supportive services face a variety of psychosocial vulnerabilities that put them at risk for depression. One group with very high risk is older adults receiving aging services through Medicaid waiver programs. This 3-year research uses a randomized controlled clinical trial to assess the effectiveness of brief behavioral therapies (problem solving therapy [PST] and Brief Behavioral Therapy for Insomnia [BBTI]) to prevent depression in seniors receiving aging services.

详细描述

The research will determine (i) if a course of problem solving therapy (PST) and Brief Behavioral Therapy for Insomnia (BBTI), with boosters, reduces incidence of major depressive episodes over 12 months relative to usual care, and (ii) the extent to which behavioral therapies achieve these effects through enhancement of protective factors, such as greater self-efficacy, better targeting of services to address needs, and greater control over home environments.

Periodic blood draws will be used to assess biosignatures of depression. Guiding our investigations of pharmacogenetics, inflammation, and proteomics are synergistic interactions among the serotonergic system, the HPA axis, systemic inflammation, growth factors such as brain derived neuro-trophic factor (BDNF), psychosocial stressors, and vascular co-morbidity. Genetic variation in vasopressin receptors, potentially involved in both cardiovascular risk and social attachment, is also associated with recurrence of depression. Similarly, genetic variation in inflammation may influence antidepressant response and medical co-morbidity.

研究设计

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

入排标准

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

入选标准

  • Age => 60 years
  • Modified Mini Mental State (3MS) Examination =>80
  • Receiving aging services or difficulty with 1+ ADL/IADL
  • PHQ-9 score > 0 and <= 9 (and question 1 or 2 is >0)

排除标准

  • Major depressive episode or anxiety disorder within 12 mo
  • Ever diagnosed with bipolar disorder or schizophrenia
  • Drug or alcohol use disorder within the past 12 months
  • Currently taking antidepressants
  • Currently taking antianxiety med >4x/week for past 4 weeks

结局指标

主要结局

Major depressive disorder

时间窗: 12 months

Patient Health Questionnaire score \> 9 with confirming diagnostic interview

Generalized anxiety disorder

时间窗: 12 months

Generalized anxiety disorder score \>=10, and meets criteria for SCID or PRIME-MD diagnosis

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

Steven M. Albert

Professor

University of Pittsburgh

研究点 (2)

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