Empower@Home: Community Implementation for Older Adults With Ambulatory Disabilities
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Change in Patient Health Questionnaire-9 (PHQ-9)
研究概览
简要总结
This study is a randomized Type I hybrid effectiveness-implementation trial aimed at evaluating the effectiveness of Empower@Home, an internet-delivered cognitive-behavioral therapy (CBT) program supported by social service providers, in comparison to enhanced usual care for depression in older adults with ambulatory disabilities. A total of 64 participants with ambulatory disabilities will be randomly assigned to either the treatment group (Empower@Home) or the control group (enhanced usual care) in a 1:1 allocation ratio.
This project addresses the following research questions:
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Does the intervention affect individuals' lives in the following expected areas?
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Does participation in the intervention lead to greater improvement in depressive symptoms than enhanced care as usual?
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Does participation in the intervention lead to greater improvement in social engagement and activities than enhanced care as usual?
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Is the intervention's primary effect mediated by CBT-related (e.g., CBT skills acquisition, cognitive distortions, and behavioral activation), engagement-related (e.g., character or storyline relatedness), and coach-related factors (e.g., therapeutic alliance)?
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How is the intervention being adopted? What are the barriers and facilitators encountered during the implementation process?
详细描述
This study is a randomized Type I hybrid effectiveness-implementation trial designed to evaluate the clinical effectiveness and implementation process of Empower@Home, an internet-delivered cognitive-behavioral therapy (CBT) program tailored for homebound older adults with depressive symptoms. The trial compares Empower@Home, supported by aging service providers, to an enhanced usual care condition. The study involves 64 participants with ambulatory disabilities who will be randomly assigned to either the treatment or control group.
Rationale: Depression is a significant public health concern among homebound older adults, with approximately 50% experiencing clinically significant depressive symptoms and 14% facing major depression-rates significantly higher than those of non-homebound counterparts. Homebound older adults often encounter barriers to accessing traditional mental health services, including physical disabilities, socioeconomic disadvantages, and racial or ethnic minority status. Empower@Home addresses these challenges by leveraging the existing workforce of aging service providers to support digital mental health interventions (DMHIs).
Intervention: Empower@Home is a nine-session, computerized CBT program enhanced with entertainment elements to increase engagement. The program is specifically designed for homebound older adults, incorporating age-relevant examples and a simplified user interface. It includes features such as a character-driven storyline, short videos, and interactive exercises to facilitate learning and engagement. The program is supported by lay coaches-aging service providers trained to offer weekly support calls, enhancing program adherence and personalization.
This project addresses the following research questions:
- Does the intervention affect individuals' lives in the following expected areas?
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Blinding interventionalists and participants is not possible, given the nature of the intervention. However, assessment staff will be blinded when possible.
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(1) be receiving or eligible to receive services at the recruitment sites
- •(2) read and speak English
- •(3) be at least 50 years old
- •(4) have at least mild depressive symptoms at screening (≥ 5 on the Patient Health Questionnaire-9 [PHQ-9]).
- •(5) Participants who are NOT currently receiving outside therapy must agree NOT to start outside therapy during study participation. Participants who are currently receiving outside therapy must agree NOT to increase their outside therapy frequency during study participation.
- •(6) have mobility limitations based on self-reported limitations in 10 mobility related questions (e.g., difficulty climbing stairs or walking)
排除标准
- •(1) probable dementia based on the Blessed Orientation and Memory Scale.
- •(2) moderate or high risk of suicide based on the 6-item Columbia-Suicide Severity Rating Scale
- •(3) a terminal illness with less than six months to live or unstable physical health conditions based on self-report
- •(4) a diagnosis of a psychotic disorder like schizophrenia or bipolar disorder based on self-report and medical chart review
- •(5) severe vision impairment based on self-report (i.e., legally blind)
- •(6) current substance use disorders or receiving substance use treatment.
- •(7) currently receiving outside therapy more frequently than once a month or have started a new therapy treatment less than 3 months ago
结局指标
主要结局
Change in Patient Health Questionnaire-9 (PHQ-9)
时间窗: Change from Baseline to follow-up assessments at 12 and 24 weeks
Change in 9 item standardized measures of depressive symptom severity. PHQ-9 score ranges from 0 to 27, with a higher score indicating more severe symptoms.
Change in Social Engagement and Activities Questionnaire (SEAQ)
时间窗: Change from Baseline to follow-up assessments at 12 and 24 weeks
Change in 10 item standardized measures of participation in social activities and community participation. The total scores range from 0 to 50, and a higher score suggesting a higher level of participation.
次要结局
- Change in Duke Social Support Index (DSSI)-10(Change from Baseline to follow-up assessments at 12 and 24 weeks)
研究者
Xiaoling Xiang
Associate Professor
University of Michigan