Interactive Voice-Based Administration of the PHQ-9

NCT04609267 | Unknown

• 1 other identifier: 2020039
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (2)

• PHQ-9 Total Scores

  Measure for Major Depressive Disorder from questionnaire responses

  Immediate

• User Experience Survey

  26 item questionnaire tracking user experience

  Immediate

Study Arms (2)

Paper Baseline

EXPERIMENTAL

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.

Diagnostic Test: PHQ-9 - Mirror format

Mirror Baseline

EXPERIMENTAL

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.

Diagnostic Test: PHQ-9 - Mirror format

Interventions

PHQ-9 - Mirror format 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.

Also known as: PHQ-9 - Amazon Alexa equipped device

Mirror Baseline; Paper Baseline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Oklahoma State University Center for Health Sciences: lead
• Oral Roberts University: collaborator

Study Sites (1)

OSU Behavioral Health Clinic

Tulsa, Oklahoma, 75135, United States

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Jason Beaman, D.O.

  Oklahoma State University Center for Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jason Beaman, D.O.

CONTACT

918-561-8269; jason.beaman@okstate.edu

Luke Lawson, M.A.

CONTACT

915-241-5853; luke.lawson@okstate.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The study will be counterbalanced with no masking components
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 26, 2020
• First Posted: October 30, 2020
• Study Start: November 3, 2020
• Primary Completion: June 18, 2021
• Study Completion: July 31, 2021
• Last Updated: July 8, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)