Interactive Voice-Based Administration of the PHQ-9

This study investigates a new delivery method for the Patient Health Questionnaire - 9 (PHQ-9), a clinically accepted tool for diagnosing major depressive disorder. The new tool records auditory responses to the assesment and the study will examine if the instrument is effective at capturing participant depression levels. If proven effective, future studies may investigate if the new format can be used to improve at home clinical care.

Study Overview

Status

Recruiting

Detailed Description

This study is an investigation of a new delivery system of the Patient Health Questionnaire - 9 (PHQ-9), a clinically accepted tool for diagnosing major depressive disorder. The purpose of the study is to examine if the new delivery system of the PHQ-9 is effective at capturing participant depression levels. The new version uses a Mirror device, which is similar to a smart television with a mirror interface. The device records auditory responses to the PHQ-9 through Amazon Alexa. We will be comparing the responses from the Mirror device to those given on the clinically established paper format. If proven effective at capturing depression levels of patients, future studies may investigate if the new format can be used to improve at home clinical care.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Oklahoma
      • Tulsa, Oklahoma, United States, 75135
        • Recruiting
        • OSU Behavioral Health Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Newly admitted patients to the Oklahoma State University Behavioral Medicine Clinic

Exclusion Criteria:

  • Vulnerable populations, such as children (i.e., minors or individuals under the legal age of consent) and individuals who are incarcerated (i.e., prisoners), will be excluded.
  • Individuals who are not their own guardian (i.e., those suffering from severe disabilities) will also be excluded.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Paper Baseline
Half of the participants will complete the PHQ-9 in the traditional paper format at their first appointment. At their second appointment 1-month later, they will complete the PHQ-9 on the Mirror device equipped with Amazon Alexa.
The intervention we will be using is a new delivery system of the PHQ-9 using an Amazon Alexa equipped Mirror device. This Mirror device is similar to a smart television with a mirror interface. The device records auditory responses to the PHQ-9. We will be comparing the responses from the Mirror device to those given on the clinically established paper format.
Other Names:
  • PHQ-9 - Amazon Alexa equipped device
EXPERIMENTAL: Mirror Baseline
Half of the participants will complete the PHQ-9 on the Mirror device equipped with Amazon Alexa at their first appointment. At their second appointment 1-month later, they will will complete the PHQ-9 in the traditional paper format.
The intervention we will be using is a new delivery system of the PHQ-9 using an Amazon Alexa equipped Mirror device. This Mirror device is similar to a smart television with a mirror interface. The device records auditory responses to the PHQ-9. We will be comparing the responses from the Mirror device to those given on the clinically established paper format.
Other Names:
  • PHQ-9 - Amazon Alexa equipped device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PHQ-9 Total Scores
Time Frame: Immediate
Measure for Major Depressive Disorder from questionnaire responses
Immediate
User Experience Survey
Time Frame: Immediate
26 item questionnaire tracking user experience
Immediate

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 3, 2020

Primary Completion (ACTUAL)

June 18, 2021

Study Completion (ANTICIPATED)

July 31, 2021

Study Registration Dates

First Submitted

October 26, 2020

First Submitted That Met QC Criteria

October 26, 2020

First Posted (ACTUAL)

October 30, 2020

Study Record Updates

Last Update Posted (ACTUAL)

July 8, 2021

Last Update Submitted That Met QC Criteria

July 6, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • 2020039

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Aggregate data and findings will be posted on ClinicalTrials.gov.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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