Voice Activated Personal Assistant for Depression Among Older Adults

Depression, Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06114485
• Other study ID #: STU#: 00211894
• Status: Recruiting
• Phase: N/A
• Start date: December 4, 2023
• Est. completion date: March 31, 2025

Study information

• Verified date: April 2024
• Source: Northwestern University
• Contact: Olga Barnas
• Phone: 312-503-4610
• Email: olga.barnas[@]northwestern.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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), the investigators 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 12 weeks. During those 12 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: March 31, 2025
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• Adults 65 years or older

• English-speaking

• Elevated depressive symptoms (PHQ-9 = 10)

• Have WiFi access

• Cognitively intact (Montreal Cognitive Assessment (MOCA) score =24)

• Homebound or difficulty leaving the home

or

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

Related Conditions & MeSH terms

• Depression
• Depression, Anxiety
• Depressive Disorder

Intervention

Behavioral:
• VIPA Treatment Program
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
• Alexa with Guidebook
Participants will receive an Alexa device with a detailed guidebook on how to use the device.

Locations

Country	Name	City	State
United States	Northwestern University	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Adherence	The number of times the Alexa device was accessed (Usage; # communications with TES-VIPA)	8 weeks