- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06114485
Voice Activated Personal Assistant for Depression Among Older Adults
Technology-Enabled Services to Support Caregivers of Older Adults With Depression
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60611
- Northwestern University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Digital Mental Health Intervention (DMHI)
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.
|
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
|
|
Active Comparator: Control Treatment (CT)
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.
|
Participants will receive an Alexa device with a detailed guidebook on how to use the device.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Depressive symptoms
Time Frame: 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 |
12 weeks
|
|
Anxiety symptoms
Time Frame: 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
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Adherence
Time Frame: 8 weeks
|
The number of times the Alexa device was accessed (Usage; # communications with TES-VIPA)
|
8 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: David C Mohr, PhD, Northwestern University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STU#: 00211894
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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