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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04609267
Other study ID # 2020039
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 3, 2020
Est. completion date July 31, 2021

Study information

Verified date July 2021
Source Oklahoma State University Center for Health Sciences
Contact Jason Beaman, D.O.
Phone 918-561-8269
Email jason.beaman@okstate.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date July 31, 2021
Est. primary completion date June 18, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

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.

Locations

Country Name City State
United States OSU Behavioral Health Clinic Tulsa Oklahoma

Sponsors (2)

Lead Sponsor Collaborator
Oklahoma State University Center for Health Sciences Oral Roberts University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary PHQ-9 Total Scores Measure for Major Depressive Disorder from questionnaire responses Immediate
Primary User Experience Survey 26 item questionnaire tracking user experience Immediate
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