The Preliminary Effects of an Internet-delivered, Layperson Facilitated Cognitive Behavioral Therapy for Depression Among Chronically Ill Older Adults: A Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 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 randomized pilot trial uses a waitlist control parallel design of a novel internet-based cognitive behavioral therapy program for older adults with elevated depressive symptoms. This study will enroll approximately 35 older adults per group throughout Michigan. The intervention will take approximately ten 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 for refining study procedures and the web platform used to deliver the program. In this new project, the study team will conduct a pilot randomized control trial to test the effectiveness of Empower@Home with older adults. Recruitment methods include 1) referrals from social service agencies, 2) advertisements on social media, local news outlets, and the program website, and 3) research participant registries.
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 20-40 minutes to complete over the phone.
Between Jan and Sept 2023, about 70 subjects (35 in each group) will be recruited. Participants will be randomized into the treatment group or waitlist control. The treatment group will receive the intervention immediately, whereas the waitlist control will wait for ten weeks before starting the intervention (i.e., after the 10-week "post-test"). Therefore, this is a cross-over design.
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
- None
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
- •≥60 years
- •have at least mild depressive symptoms, based on PHQ-9 >=8
- •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)
- •Have a self reported psychotic disorder
- •Currently receiving psychotherapy
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 Generalized Anxiety Disorder Assessment-7 (GAD-7)(Change from Baseline at 10 weeks)
- Change in Patient-Reported Outcomes Measurement Information Systems (PROMIS)-Global Health(Change from Baseline at 10 weeks)
- Change in Patient-Reported Outcomes Measurement Information Systems (PROMIS)-Social Isolation(Change from Baseline at 10 weeks)
- Change in EQ5D-5L(Change from Baseline at 10 weeks)
研究者
Xiaoling Xiang
Assistant Professor
University of Michigan