Interactive Voice-Based Administration of the PHQ-9

NCT ID: NCT04609267

Last Updated: 2021-07-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-03

Study Completion Date

2021-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Major Depressive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

This study will be a repeated measure, mixed methods design (i.e., it will contain both qualitative and quantitative components). Newly admitted patients will be asked to complete the questionnaires (i.e., PHQ-9 and the UEQ) at two different time points (i.e., Baseline and 1-month follow-up). In order to reduce or control for order effects, the procedure will be counterbalanced.
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

The study will be counterbalanced with no masking components

Study Groups

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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.

Group Type EXPERIMENTAL

PHQ-9 - Mirror format

Intervention Type DIAGNOSTIC_TEST

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.

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.

Group Type EXPERIMENTAL

PHQ-9 - Mirror format

Intervention Type DIAGNOSTIC_TEST

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.

Interventions

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PHQ-9 - Mirror 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.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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PHQ-9 - Amazon Alexa equipped device

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Oral Roberts University

UNKNOWN

Sponsor Role collaborator

Oklahoma State University Center for Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jason Beaman, D.O.

Role: PRINCIPAL_INVESTIGATOR

Oklahoma State University Center for Health Sciences

Locations

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OSU Behavioral Health Clinic

Tulsa, Oklahoma, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Jason Beaman, D.O.

Role: CONTACT

918-561-8269

Luke Lawson, M.A.

Role: CONTACT

915-241-5853

Facility Contacts

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Jason Beaman, D.O.

Role: primary

918-561-8269

Other Identifiers

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2020039

Identifier Type: -

Identifier Source: org_study_id

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