- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04609267
Interactive Voice-Based Administration of the PHQ-9
July 6, 2021 updated by: Oklahoma State University Center for Health Sciences
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Anticipated)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Oklahoma
-
Tulsa, Oklahoma, United States, 75135
- Recruiting
- OSU Behavioral Health Clinic
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: NONE
Arms and Interventions
Participant Group / 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.
|
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 Names:
|
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.
|
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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PHQ-9 Total Scores
Time Frame: Immediate
|
Measure for Major Depressive Disorder from questionnaire responses
|
Immediate
|
User Experience Survey
Time Frame: Immediate
|
26 item questionnaire tracking user experience
|
Immediate
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
November 3, 2020
Primary Completion (ACTUAL)
June 18, 2021
Study Completion (ANTICIPATED)
July 31, 2021
Study Registration Dates
First Submitted
October 26, 2020
First Submitted That Met QC Criteria
October 26, 2020
First Posted (ACTUAL)
October 30, 2020
Study Record Updates
Last Update Posted (ACTUAL)
July 8, 2021
Last Update Submitted That Met QC Criteria
July 6, 2021
Last Verified
July 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020039
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Aggregate data and findings will be posted on ClinicalTrials.gov.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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