Depression Agency-Based Collaborative (Depression ABC)
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
- 否
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
Steven M. Albert
Professor
University of Pittsburgh
