EM/PROTECT-Hybrid: Improving Depression in Elder Mistreatment Victims
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in Assessment of Stress, as Measured by the PSS
研究概览
简要总结
The investigators developed EM/PROTECT, a behavioral intervention for depressed EM (elderly mistreatment) victims, to work in synergy with EM mistreatment resolution services that provide safety planning, support services, and links to legal services. PROTECT is built on a model which postulates that chronic stress promotes dysfunction of the cognitive control (CCN) and reward networks, impairing the victims' ability to flexibly respond to the environment and limits their reward activities. PROTECT therapists work with victims to develop action plans to reduce stress, and to increase rewarding experiences. EM/PROTECT has been designed in an iterative process with community EM providers of the New York City (NYC) Department for the Aging (DFTA) to use agencies' routine PHQ-9 depression screening and referral for service. In the current study, the investigators will compare the effectiveness of EM/PROTECT with EM enriched with staff training in linking EM victims to community mental health services (EM/MH). The investigators intend to enroll 50 subjects that will participate in the study for approximately 12 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •55 years of age or older
- •Capacity to consent (per Elder Mistreatment staff)
- •Significant depression (per Elder Mistreatment staff) as indicated by a score of 10 or above on the Patient Health Questionnaire-9 (PHQ-9), a widely used screening tool routinely administered in Elder Mistreatment (EM) agency settings (the PHQ-9 has a sensitivity of 88% and a specificity of 88% for major depression)
- •Need for EM services
排除标准
- •Active suicidal ideation (Montgomery Asberg Depression Rating Scale item 10>4)
- •Inability to speak English or Spanish
- •Axis 1 Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) diagnoses other than unipolar depression or generalized anxiety disorder (by Structured Clinical Interview for DSM-5)
- •Severe or life-threatening medical illness
- •EM emergency and or referral out of EM agency (per EM staff)
结局指标
主要结局
Change in Assessment of Stress, as Measured by the PSS
时间窗: Baseline, 6 weeks
In all conditions, changes in assessment of stress measured by the Perceived Stress Scale (PSS) scale. Scores range from 0-40. Scores ranging from 0-13 are considered low stress, scores ranging from 14-26 are considered moderate stress, and scores ranging from 27-40 are considered high perceived stress.
Change in Clinically Significant Depressive Symptoms as Measured by the MADRS
时间窗: 6 weeks, 9 weeks, 12 weeks
In all conditions, the change in clinically significant depressive symptoms as measured on the Montgomery Asberg Depression Rating Scale (MADRS). Scores are categorized as following: 0 to 6 - Normal /symptom absent. 7 to 19 - Mild depression. 20 to 34 - Moderate depression. \>34 - Severe depression. The scores presented for each time point are absolute values.
Change in Assessment of Quality of Life, as Measured by the WHO-QOL
时间窗: 6 weeks, 9 weeks, 12 weeks
In all conditions, changes in assessment of quality of life measured by the World Health Organization Quality of Life (WHO-QOL) scale. World Health Organization-Quality Of Life scale. The overall scores range between 26-130. In all domains, higher scores indicate better health. Domain 1 measures physical health (scores range from 7-35). Domain 2 measures psychological health (scores range from 6-30). Domain 3 measures social health (scores range from 3-15). Domain 4 measures environmental health (scores range from 8-40). The scores presented for each time point are absolute values.
次要结局
- Change in Assessment of Exposure to Meaningful Activities, as Measured by the BADS(Baseline, 6 weeks)