Technology Assisted Intervention for the Treatment and Prevention of Depression
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Patient Health Questionnaire - 9 (PHQ-9) - Depression Severity Module
研究概览
简要总结
The goal of this field trial is to tailor and test a web-based intervention in adults 65 years of age or older. Two versions of the web-based intervention have been created and will be tested--one with an online social network and one without an online social network. The purpose of this study is to: pilot a novel intervention, examine methods to improve adherence to web-based interventions (e.g., peer network); collect data on feasibility, acceptability, and efficacy of an web-based intervention for late life depression; and ultimately, to overcome the numerous barriers to treating depression in later life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has elevated depressive symptoms
- •Has a telephone, e-mail account, computer, and broadband access to the Internet.
- •Has basic internet skills and is able to access the internet independently
- •Is able to speak and read English.
- •Is at least 65 years of age.
- •Is able to give informed consent.
排除标准
- •Has hearing or voice impairment that would prevent participation in psychotherapy
- •Has visual impairment that would prevent completion of assessment materials.
- •Is diagnosed with a psychotic disorder, bipolar disorder, dissociative disorder, current substance abuse, or other diagnosis for which participation in a clinical trial of psychotherapy may be either inappropriate or dangerous.
- •Is currently receiving individual psychotherapy or planning to receive psychotherapy during the 8-week treatment phase of the study
- •Is planning to be out of town or unavailable for an extended period of time during the study without access to the Internet
- •Exhibits severe suicidality, including ideation, plan, and intent.
- •Has initiated treatment with an antidepressant in past 14 days. Once patients have been on a stable dose for 14 days and do not have an appointment with a physician or psychiatrist to change this dose, the patient will be eligible based on this criterion.
研究组 & 干预措施
Individual Internet Intervention (III)
Coached internet intervention based on the principles of cognitive behavioral therapy (CBT) for depressed older adults delivered individually by 2 clinical psychologists.
(iCBT for late life depression without social network included.)
干预措施: iCBT for late life depression (Behavioral)
Internet Intervention+Peer Supp.(II+PS)
Coached internet intervention based on the principles of cognitive behavioral therapy (CBT) for depressed older adults delivered with peer support; group moderation was provided by 2 clinical psychologists.
(iCBT for late life depression with social network included.)
干预措施: iCBT for late life depression (Behavioral)
Waitlist Control (WLC)
Waiting period, no intervention administered. WLC participants received access to the III following the 8-week waiting period.
结局指标
主要结局
Patient Health Questionnaire - 9 (PHQ-9) - Depression Severity Module
时间窗: Baseline and Week 8 - Difference in PHQ-9 score
The PHQ-9 measures degree of depression severity. Possible range of scores for the PHQ-9 is 0-27. Higher values represent a worse outcome. Specifically, scores of 0-4 indicate minimal or no depression; 5-9 is mild; 10-14 is moderate; 15-19 is moderately severe; and 20-27 is severe. The data table below shows PHQ-9 pre- and post- intervention score differences by group.
Mean Number of Sessions Across the 8-week Trial
时间窗: 8 weeks
Average Coaching Time Per Participant by Group
时间窗: 8 weeks
The average time spent on messages and calls and on group moderation.
System Usability Scale (SUS)
时间窗: Week 8
The System Usability Scale (SUS) is a usability scale that can be used for global assessments of systems usability. It consists of a 10 item questionnaire with five response options for respondents; from Strongly agree to Strongly disagree. Originally created by John Brooke in 1986, it allows you to evaluate a wide variety of products and services, including hardware, software, mobile devices, websites and applications. The participant's scores for each question are converted to a new number, added together and then multiplied by 2.5 to convert the original scores of 0-40 to 0-100. A SUS score above a 68 would be considered above average and anything below 68 is below average.
次要结局
未报告次要终点
研究者
David Mohr
Director, Center for Behavioral Intervention Technologies; Professor, Department of Preventive Medicine
Northwestern University