Clinical trial NCT06114485: Voice Activated Personal Assistant for Depression Among Older Adults
Official title: Technology-Enabled Services to Support Caregivers of Older Adults With Depression
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Depression, Anxiety
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2023-11-02
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial
Primary purpose: TREATMENT

Brief summary: 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.

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 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.

Eligibility criteria: Inclusion criteria:

* 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)

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
* Cognitively intact (Montreal Cognitive Assessment (MOCA) score ≥17 if 65 years or older)

Primary outcomes:
measure: Depressive symptoms
timeFrame: 12 weeks
measure: Anxiety symptoms
timeFrame: 12 weeks
Secondary outcomes:
measure: Adherence
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
affiliation: Northwestern University
name: David C Mohr, PhD
role: PRINCIPAL_INVESTIGATOR
References: