Community-Embedded, Layperson-Supported Digital Mental Health Intervention for Homebound Older Adults With Depression: A Type 1 Hybrid Effectiveness- Implementation RCT
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 256
- 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 aging service providers, in comparison to enhanced usual care for homebound older adults with depressive symptoms. A total of 256 participants will be randomly assigned to either the treatment group (Empower@Home) or the control group (enhanced usual care) in a 1:1 allocation ratio, with randomization stratified by participating agencies.
The primary aim of this study is to determine the clinical effectiveness of the Empower@Home program. We hypothesize that participants receiving Empower@Home will show greater improvements in depressive symptoms at 12, 24, and 36 weeks after entering the study compared to those receiving enhanced usual care. Additionally, we will explore treatment moderators and perform a cost-effectiveness analysis to assess the economic viability of the intervention.
The second aim is to investigate the mechanisms of change facilitated by the intervention using a mixed-methods approach. Through causal mediation analysis, we will examine whether the acquisition of CBT skills, reduction in cognitive distortions, and increased behavioral activation, as well as participant engagement and the therapeutic alliance with the coach, mediate the treatment effects. Qualitative interviews with participants will be conducted to provide deeper insights into these mechanisms and enhance the interpretation of the mediation analysis.
The third aim focuses on evaluating the implementation process using the updated Consolidated Framework for Implementation Research (CFIR). This will involve a qualitative process evaluation to identify barriers and facilitators to the implementation of Empower@Home, drawing on perspectives from multiple stakeholders.
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 256 participants who will be randomly assigned to either the treatment or control group, with randomization stratified by agency.
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.
Study Aims:
Effectiveness: The primary aim is to determine the clinical effectiveness of Empower@Home compared to enhanced usual care. The hypothesis is that participants in the Empower@Home group will show greater improvements in depressive symptoms at 12, 24, and 36 weeks post-enrollment. Secondary clinical outcomes include improvements in anxiety, loneliness, social support, quality of life, disability burden, and pain severity.
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 moderate depressive symptoms at screening (≥ 8 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.
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, 24, and 36 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.
次要结局
- Change in Duke Social Support Index (DSSI)-10(Change from Baseline to follow-up assessments at 12, 24, and 36 weeks)
- Change in EuroQol 5-Dimension 5-level (EQ-5D-5L)(Change from Baseline to follow-up assessments at 12, 24, and 36 weeks)
- Change in Hamilton Depression Rating Scale (HAM-D)(Change from Baseline to follow-up assessments at 12, 24, and 36 weeks)
- Change in WHO Disability Assessment Schedule 2.0 (WHODAS 2.0)(Change from Baseline at 12, 24, and 36 weeks)
- Change in Pain intensity assessed by the Pain, Enjoyment, and General Activity (PEG) Scale(Change from Baseline to follow-up assessments at 12, 24, and 36 weeks)
- Change in Generalized Anxiety Disorder Assessment-7 (GAD-7)(Change from Baseline to follow-up assessments at 12, 24, and 36 weeks)
研究者
Xiaoling Xiang
Xiaoling Xiang, PhD
University of Michigan