search
Back to results

Interactive Voice-Based Administration of the PHQ-9

Primary Purpose

Major Depressive Disorder

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PHQ-9 - Mirror format
Sponsored by
Oklahoma State University Center for Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Major Depressive Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • OSU Behavioral Health ClinicRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Paper Baseline

Mirror Baseline

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

PHQ-9 Total Scores
Measure for Major Depressive Disorder from questionnaire responses
User Experience Survey
26 item questionnaire tracking user experience

Secondary Outcome Measures

Full Information

First Posted
October 26, 2020
Last Updated
July 6, 2021
Sponsor
Oklahoma State University Center for Health Sciences
Collaborators
Oral Roberts University
search

1. Study Identification

Unique Protocol Identification Number
NCT04609267
Brief Title
Interactive Voice-Based Administration of the PHQ-9
Official Title
Interactive Voice-Based Administration of the PHQ-9
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
November 3, 2020 (Actual)
Primary Completion Date
June 18, 2021 (Actual)
Study Completion Date
July 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oklahoma State University Center for Health Sciences
Collaborators
Oral Roberts University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Paper Baseline
Arm Type
Experimental
Arm Description
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.
Arm Title
Mirror Baseline
Arm Type
Experimental
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
PHQ-9 - Mirror format
Other Intervention Name(s)
PHQ-9 - Amazon Alexa equipped device
Intervention Description
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.
Primary Outcome Measure Information:
Title
PHQ-9 Total Scores
Description
Measure for Major Depressive Disorder from questionnaire responses
Time Frame
Immediate
Title
User Experience Survey
Description
26 item questionnaire tracking user experience
Time Frame
Immediate

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jason Beaman, D.O.
Phone
918-561-8269
Email
jason.beaman@okstate.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Luke Lawson, M.A.
Phone
915-241-5853
Email
luke.lawson@okstate.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jason Beaman, D.O.
Organizational Affiliation
Oklahoma State University Center for Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
OSU Behavioral Health Clinic
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
75135
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jason Beaman, D.O.
Phone
918-561-8269
Email
jason.beaman@okstate.edu

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Aggregate data and findings will be posted on ClinicalTrials.gov.

Learn more about this trial

Interactive Voice-Based Administration of the PHQ-9

We'll reach out to this number within 24 hrs