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临床试验/NCT06114485
NCT06114485进行中(未招募)不适用

Technology-Enabled Services to Support Caregivers of Older Adults With Depression

Northwestern University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2023年12月4日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
80
试验地点
1
主要终点
Anxiety symptoms

研究概览

简要总结

Participants will use Amazon Alexa to test a new voice-assisted program for mental health management. The participant will use this program to help with goal setting, reminders, and various other services. The participant may be supported by a caregiver, if available, or by research team member who will serve as a coach for the duration of the study to guide them with using the program. Participants will be asked to complete surveys and assessments about their experiences during the 12-week study period. Participants will be randomized into two groups: those who receive a guide to help them with utilization of the program to its fullest potential and those who do not receive that guide.

详细描述

Older adults have often been on the fringe of benefiting from technology. However, voice-controlled intelligent personal assistants (VIPAs; e.g. Google Home, Amazon Echo), with their natural interaction style and ease of use, are a simple interface technology that may be useful to older adults with depression in the home setting. The caregiver or coach will be able to schedule and follow the interactions between the older adult and the VIPA. The VIPAs would potentially be able to provide functional, cognitive, and social stimulation as well as improve anti-depressant medication adherence through reminders to older adults.

The aim is to evaluate a VIPA that was designed to deliver behavioral activation prompts to older adults with depression. Through user centered design (UCD), the investigators have adapted the model for remote support with the aid of VIPAs that provide psychoeducation, as well as features that support social, cognitive, and functional stimulation and reminders.

The intervention will be 8 weeks, with a 4-week follow-up. During 8-week intervention, participants will be able to use Amazon Echo Show 8 and the study's VIPA program to set goals, reminders, and the like to help with their mood. Participants will also be asked to completed associated assessments. If caregivers are involved, they will also be asked to complete assessments.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults 65 years or older
  • English-speaking
  • Elevated depressive symptoms (PHQ-9 ≥ 10)
  • Have Wi-Fi access
  • Cognitively intact (Montreal Cognitive Assessment (MOCA) score ≥17)
  • Inclusion criteria:
  • Adults 18 years or older
  • English-speaking
  • Provide support to an older adult (65 or older)
  • Have access to Wi-Fi
  • Demonstrating capacity to consent
  • Cognitively intact (Montreal Cognitive Assessment (MOCA) score ≥17 if 65 years or older)

排除标准

  • 未提供

研究组 & 干预措施

Digital Mental Health Intervention (DMHI)

Experimental

Participants randomized to Arm 1 will be sent an Amazon Alexa device, with a newly designed VIPA treatment program installed, and will receive a guidebook to help the older adult understand the device and utilize the VIPA treatment program to its fullest potential.

干预措施: VIPA Treatment Program (Behavioral)

Control Treatment (CT)

Active Comparator

Participants randomized to Arm 2 will be sent an Amazon Alexa device with guidebook to help the older adult understand how to use the device.

干预措施: Alexa with Guidebook (Behavioral)

结局指标

主要结局

Anxiety symptoms

时间窗: 12 weeks

The Generalized Anxiety Disorder-7 (GAD-7) measures anxiety symptom severity on a scale of 0-21, with higher scores indicating greater severity

Depressive symptoms

时间窗: 12 weeks

The Patient Health Questionnaire-9 (PHQ-9) PHQ-9 measures depression symptom severity on a scale of 0-27, with higher scores indicating greater symptom severity. The PHQ-9 measures depressive symptom severity on a scale of 0-27, with higher scores indicating greater severity

次要结局

  • Adherence(8 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Allison Carroll

Research Assistant Professor

Northwestern University

研究点 (1)

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