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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

Tracking Information
First Submitted Date  ICMJE October 26, 2020
First Posted Date  ICMJE October 30, 2020
Last Update Posted Date July 8, 2021
Actual Study Start Date  ICMJE November 3, 2020
Actual Primary Completion Date June 18, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 16, 2020)
  • PHQ-9 Total Scores [ Time Frame: Immediate ]
    Measure for Major Depressive Disorder from questionnaire responses
  • User Experience Survey [ Time Frame: Immediate ]
    26 item questionnaire tracking user experience
Original Primary Outcome Measures  ICMJE
 (submitted: October 26, 2020)
  • PHQ-9 Total Scores [ Time Frame: Immediate ]
    Measure for Major Depressive Disorder from questionnare responses
  • User Experience Survey [ Time Frame: Immediate ]
    26 item questionnare tracking user experience
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Interactive Voice-Based Administration of the PHQ-9
Official Title  ICMJE Interactive Voice-Based Administration of the PHQ-9
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Major Depressive Disorder
Intervention  ICMJE 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
Study Arms  ICMJE
  • 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.
    Intervention: Diagnostic Test: PHQ-9 - Mirror format
  • 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.
    Intervention: Diagnostic Test: PHQ-9 - Mirror format
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 26, 2020)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 31, 2021
Actual Primary Completion Date June 18, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Jason Beaman, D.O. 918-561-8269 jason.beaman@okstate.edu
Contact: Luke Lawson, M.A. 915-241-5853 luke.lawson@okstate.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04609267
Other Study ID Numbers  ICMJE 2020039
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Aggregate data and findings will be posted on ClinicalTrials.gov.
Responsible Party Oklahoma State University Center for Health Sciences
Study Sponsor  ICMJE Oklahoma State University Center for Health Sciences
Collaborators  ICMJE Oral Roberts University
Investigators  ICMJE
Principal Investigator: Jason Beaman, D.O. Oklahoma State University Center for Health Sciences
PRS Account Oklahoma State University Center for Health Sciences
Verification Date July 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP