Voice Activated Personal Assistant for Depression Among Older Adults

Study Overview
=================
Brief Summary
-----------------
Participants will use Amazon Alexa to test a new voice-assisted program for mental health management. The older adult and their support person will use this program to help with goal setting, reminders, and various other services. Participants will be asked to complete surveys and assessments about their experiences during the 16-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.

Detailed Description
-----------------
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 and their caregivers in the home setting. Caregivers would 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 provide the caregiver with the skills and tools to deliver stimulation and medication reminders to homebound older adults with depression. The program model is based on a simplified behavioral activation program designed for administration by lay persons. Through user centered design (UCD), we have adapted the model for remote delivery by a caregiver with the aid of VIPAs that provide psychoeducation, as well as features that support social, cognitive, and functional stimulation and reminders. The ability to deliver a caregiver-coordinated depression management program remotely, through an easy-to-use voice activated end-user interface, has the potential to deliver cost-effective care, easily implementable, to millions of homebound older adults, who currently are unable to access effective treatment. The study duration will be 16 weeks. During those 16 weeks, 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. Caregivers will be able to interact with a dashboard to see how their older adult participant is faring and also be asked to complete assessments.

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

Conditions
-----------------
Depression, Anxiety

Intervention / Treatment
-----------------
* Behavioral: VIPA Treatment Program
* Behavioral: Alexa with Guidebook


Participation Criteria
=================
Eligibility Criteria
-----------------
Older adults: Inclusion criteria: Adults 65 years or older; English-speaking; elevated depressive symptoms (PHQ-9 ≥ 10), cognitively intact (Montreal Cognitive Assessment (MOCA) score ≥24); homebound defined by having physical impairment, difficulty leaving the home, or requiring the assistance of another person to leave their home; have access to Wi-Fi; and demonstrating capacity to consent. Caregivers: Inclusion criteria: Adults 18 years or older; English-speaking; provide ≥2 hours of weekly support (e.g. emotional, social, physical, task-related) to the older adult; have access to Wi-Fi; and demonstrating capacity to consent.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized Controlled Trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Digital Mental Health Intervention (DMHI)<br>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 and their caregiver understand the device and utilize the VIPA treatment program to its fullest potential. | Behavioral: VIPA Treatment Program<br>* Participants will receive and Alexa device with a behavioral activation program, along with a detailed guidebook about how to utilize the Alexa device and the VIPA program<br>|
| Active Comparator: Control Treatment (CT)<br>Participants randomized to Arm 2 will be sent an Amazon Alexa device with guidebook to help the older adult and their caregiver understand how to use the device. | Behavioral: Alexa with Guidebook<br>* Participants will receive an Alexa device with a detailed guidebook on how to use the device.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depressive symptoms | 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 | 16 weeks | 
| Anxiety symptoms | The Generalized Anxiety Disorder-7 (GAD-7) measures anxiety symptom severity on a scale of 0-21, with higher scores indicating greater severity | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence | The number of times the Alexa device was accessed (Usage; # communications with TES-VIPA) | 8 weeks |