NCT06114485

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
1mo left

Started Dec 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress96%
Dec 2023Jun 2026

First Submitted

Initial submission to the registry

October 28, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 2, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

December 4, 2023

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 16, 2025

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Expected
Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

1.3 years

First QC Date

October 28, 2023

Last Update Submit

April 7, 2026

Conditions

Depression, Anxiety

Outcome Measures

Primary Outcomes (2)

  • 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

    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

    12 weeks

Secondary Outcomes (1)

  • Adherence

    8 weeks

Study Arms (2)

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.

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.

Behavioral: Alexa with Guidebook

Interventions

VIPA Treatment ProgramBEHAVIORAL

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

Digital Mental Health Intervention (DMHI)
Alexa with GuidebookBEHAVIORAL

Participants will receive an Alexa device with a detailed guidebook on how to use the device.

Control Treatment (CT)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)
  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

DepressionAnxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental Disorders

Study Officials

  • David C Mohr, PhD

    Northwestern University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized Controlled Trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant Professor

Study Record Dates

First Submitted

October 28, 2023

First Posted

November 2, 2023

Study Start

December 4, 2023

Primary Completion

March 16, 2025

Study Completion (Estimated)

June 30, 2026

Last Updated

April 13, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

Data will be shared through the NIMH Data Archive

Time Frame
Data will be available 1 year after completion of the study.
Access Criteria
Approval by NIMH Data Archive
More information

Locations

US(1)