Evaluating the Effectiveness of Empower@Home for Depression Among Older Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 240
- 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 is a single group study of a novel internet-based cognitive behavioral therapy program for older adults with elevated depressive symptoms. This study will enroll approximately 300 older adults throughout the state of Michigan to test the effectiveness of Empower@Home with older adults. The intervention will take approximately 10 weeks to complete. Participants will have lower levels of depression after completing the intervention than before enrollment. Participants will be able to use the internet-based platform with minimal support.
详细描述
Depression affects up to 40% of homebound seniors but most homebound seniors do not receive psychotherapy due to various access barriers. The study team focuses on developing community-based solutions to reduce these access barriers. In a previously approved project HUM00207612, the study team tested the feasibility of a novel internet-based cognitive behavioral therapy (iCBT) program called Empower@Home. The pilot project allowed refining study procedures and the web platform used to deliver the program. In this new project, the study team will conduct a larger single group study to test the effectiveness of Empower@Home with older adults. Recruitment methods include 1) referrals from social service agencies and 2) advertisements on social media and the program website.
The intervention involves attending up to 9 pre-recorded online therapy sessions and receiving weekly coaching calls from trained research assistants for up to 10 weeks. Participants will engage in therapy in their private homes. Three assessments are scheduled, including a comprehensive baseline, a post-test, and a 10-week follow-up. Each assessment takes about 40 minutes to complete over the phone or via an online survey, depending on the participants' preference.
Subjects will be recruited from agency referrals and advertisements. Between May 2022 and Dec 2023, about 300 subjects will be recruited into a single group study design where all eligible and consented participants will receive the intervention immediately without waiting.
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •have at least mild depressive symptoms, based on PHQ-9 >=5
- •are willing to participate
排除标准
- •Probable cognitive impairment based on the Blessed Orientation, Memory, and Concentration scale (score >9).
- •They do not speak English
- •have active suicidal ideation, defined as moderate to high risk based on the 6-item Columbia-Suicide Severity Rating Scale (C-SSRS)
- •Have a terminal illness or unstable physical health with a high risk of hospitalization within the next 3 months
- •Have severe vision impairment that can not be corrected and with no in-home help to assist them with using a mobile device
- •possible substance use disorders as assessed by the 4-item CAGE screener (>=2 on the CAGE AND have not been sober for at least one year)
结局指标
主要结局
Change in Patient Health Questionnaire-9 (PHQ-9)
时间窗: Change from Baseline PHQ-9 at 10 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.
Modified Treatment Evaluation Inventory
时间窗: 10 weeks
11-item Likert scale relating to acceptability of program to participant modified for older adults and the study context. The score ranges from 11 to 55, and a higher score means higher acceptability.
次要结局
- Change in Duke Social Support Index (DSSI)-10(Change from Baseline at 10 weeks)
- Change in PROMISE-SI(Change from Baseline at 10 weeks)
- Change in Generalized Anxiety Disorder Assessment-7 (GAD-7)(Change from Baseline at 10 weeks)
研究者
Xiaoling Xiang
Xiaoling Xiang, PhD, MSW, Assistant Professor
University of Michigan