Major Depressive DisorderNCT04609267
Interactive Voice-Based Administration of the PHQ-9
A study testing PHQ-9 - Mirror format in people with Major Depressive Disorder, run by Oklahoma State University Center for Health Sciences at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- PHQ-9 - Mirror format
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Nov 2020to 31 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Newly admitted patients to the Oklahoma State University Behavioral Medicine Clinic
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
OSU Behavioral Health Clinic
Tulsa, Oklahoma, 75135
Jason Beaman, D.O., 918-561-8269, jason.beaman@okstate.edu
About this study
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.
Read the 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.
- Conditions
- Major Depressive Disorder
- Being tested
- PHQ-9 - Mirror format
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PHQ-9 - Mirror formatDiagnostic test
Also called PHQ-9 - Amazon Alexa equipped device
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.
| Study group | Role | What they receive |
|---|---|---|
| Paper Baseline | Experimental | 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. Receives: Diagnostic Test: PHQ-9 - Mirror format |
| Mirror Baseline | Experimental | 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. Receives: Diagnostic Test: PHQ-9 - Mirror format |
What is being measured
The primary outcome is the main question the study is designed to answer.
PHQ-9 Total Scores
Measure for Major Depressive Disorder from questionnaire responses
Measured: Immediate
User Experience Survey
26 item questionnaire tracking user experience
Measured: Immediate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2020
- Study start3 Nov 2020
- Primary completion18 Jun 2021
- Study completion31 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- 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)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oklahoma State University Center for Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Oral Roberts University
- Responsible party
- Sponsor
- Investigators
- Jason Beaman, D.O., Principal investigator, Oklahoma State University Center for Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04609267
- Sponsor's protocol ID
- 2020039
- Status last verified
- Jul 2021
- First submitted
- 26 Oct 2020
- Last updated
- 8 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Aggregate data and findings will be posted on ClinicalTrials.gov.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interactive Voice-Based Administration of the PHQ-9
- ClinicalTrials.gov ID
- NCT04609267
- Acronym / sponsor ID
- 2020039
- Conditions
- Major Depressive Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Oklahoma State University Center for Health SciencesUniversity, hospital or other
- Collaborators
- Oral Roberts University
- Study start
- 3 Nov 2020 (actual)
- Primary completion
- 18 Jun 2021 (actual)
- Study completion
- 31 Jul 2021 (estimated)
- First posted
- 30 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Paper Baseline | Experimental | Diagnostic Test: PHQ-9 - Mirror formatHalf 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. |
| Mirror Baseline | Experimental | Diagnostic Test: PHQ-9 - Mirror formatHalf 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Newly admitted patients to the Oklahoma State University Behavioral Medicine Clinic
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PHQ-9 - Mirror formatAlso: PHQ-9 - Amazon Alexa equipped deviceThe 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. | Diagnostic test | Mirror Baseline, Paper Baseline |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2021.
- Individual participant dataSharing planned: No. Aggregate data and findings will be posted on ClinicalTrials.gov.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jason Beaman, D.O. principal investigator
Oklahoma State University Center for Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PHQ-9 - Mirror format in people with Major Depressive Disorder, run by Oklahoma State University Center for Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jason Beaman, D.O. (918-561-8269, jason.beaman@okstate.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PHQ-9 Total Scores (time frame: Immediate). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2021.