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Interactive Voice-Based Administration of the PHQ-9

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ClinicalTrials.gov Identifier: NCT04609267
Recruitment Status : Recruiting
First Posted : October 30, 2020
Last Update Posted : July 8, 2021
Sponsor:
Collaborator:
Oral Roberts University
Information provided by (Responsible Party):
Oklahoma State University Center for Health Sciences

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.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Diagnostic Test: PHQ-9 - Mirror format Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Masking Description: The study will be counterbalanced with no masking components
Primary Purpose: Diagnostic
Official Title: Interactive Voice-Based Administration of the PHQ-9
Actual Study Start Date : November 3, 2020
Actual Primary Completion Date : June 18, 2021
Estimated Study Completion Date : July 31, 2021

Resource links provided by the National Library of Medicine


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.
Diagnostic Test: 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.
Other Name: 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.
Diagnostic Test: 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.
Other Name: PHQ-9 - Amazon Alexa equipped device




Primary Outcome Measures :
  1. PHQ-9 Total Scores [ Time Frame: Immediate ]
    Measure for Major Depressive Disorder from questionnaire responses

  2. User Experience Survey [ Time Frame: Immediate ]
    26 item questionnaire tracking user experience



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04609267


Contacts
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Contact: Jason Beaman, D.O. 918-561-8269 jason.beaman@okstate.edu
Contact: Luke Lawson, M.A. 915-241-5853 luke.lawson@okstate.edu

Locations
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United States, Oklahoma
OSU Behavioral Health Clinic Recruiting
Tulsa, Oklahoma, United States, 75135
Contact: Jason Beaman, D.O.    918-561-8269    jason.beaman@okstate.edu   
Sponsors and Collaborators
Oklahoma State University Center for Health Sciences
Oral Roberts University
Investigators
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Principal Investigator: Jason Beaman, D.O. Oklahoma State University Center for Health Sciences
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Responsible Party: Oklahoma State University Center for Health Sciences
ClinicalTrials.gov Identifier: NCT04609267    
Other Study ID Numbers: 2020039
First Posted: October 30, 2020    Key Record Dates
Last Update Posted: July 8, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Aggregate data and findings will be posted on ClinicalTrials.gov.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Depressive Disorder
Depressive Disorder, Major
Mood Disorders
Mental Disorders