Depression, AnxietyNCT06114485
Voice Activated Personal Assistant for Depression Among Older Adults
A study testing VIPA Treatment Program and Alexa with Guidebook in people with Depression, Anxiety, run by Northwestern University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression, Anxiety
- What is being tested?
- VIPA Treatment Program and Alexa with Guidebook
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Dec 2023to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Technology-Enabled Services to Support Caregivers of Older Adults With Depression
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.
Read the 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.
- Conditions
- Depression, Anxiety
- Being tested
- VIPA Treatment Program, Alexa with Guidebook
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VIPA Treatment ProgramBehavioural
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 GuidebookBehavioural
Participants will receive an Alexa device with a detailed guidebook on how to use the device.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: VIPA Treatment Program |
| 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. Receives: Behavioral: Alexa with Guidebook |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 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
Measured: 12 weeks
Secondary outcomes (1)
Adherence
The number of times the Alexa device was accessed (Usage; # communications with TES-VIPA)
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2023
- Study start4 Dec 2023
- Primary completion16 Mar 2025
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression, AnxietyStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Allison Carroll, Northwestern University
- Investigators
- David C Mohr, PhD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06114485
- Sponsor's protocol ID
- STU#: 00211894
- Status last verified
- Apr 2026
- First submitted
- 28 Oct 2023
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared through the NIMH Data Archive
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Technology-Enabled Services to Support Caregivers of Older Adults With Depression
- ClinicalTrials.gov ID
- NCT06114485
- Acronym / sponsor ID
- STU#: 00211894
- Conditions
- Depression, Anxiety
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 4 Dec 2023 (actual)
- Primary completion
- 16 Mar 2025 (actual)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 2 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Digital Mental Health Intervention (DMHI) | Experimental | Behavioral: VIPA Treatment ProgramParticipants 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. |
| Control Treatment (CT) | Active comparator | Behavioral: Alexa with GuidebookParticipants randomized to Arm 2 will be sent an Amazon Alexa device with guidebook to help the older adult understand how to use the device. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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)
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VIPA Treatment ProgramParticipants 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 | Behavioural | Digital Mental Health Intervention (DMHI) |
| Alexa with GuidebookParticipants will receive an Alexa device with a detailed guidebook on how to use the device. | Behavioural | Control Treatment (CT) |
Primary outcome
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
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
1 secondary outcome
Adherence
Time frame: 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: Yes. Data will be shared through the NIMH Data Archive
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David C Mohr, PhD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VIPA Treatment Program and Alexa with Guidebook in people with Depression, Anxiety, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depressive symptoms (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.