General Anxiety DisorderNCT04990492
Interactive Voice Based Administration of the GAD 7
A study testing Paper GAD 7 and Voice Administered GAD 7 in people with General Anxiety 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 General Anxiety Disorder - 7 (GAD 7), a clinically accepted tool for diagnosing general anxiety disorder. The new tool records auditory responses to the assessment and the study will examine if the instrument is effective at capturing participant depression levels. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- General Anxiety Disorder
- What is being tested?
- Paper GAD 7 and Voice Administered GAD 7
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jun 2021to 15 Jun 2022
- 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
Luke Lawson, M.A., 918-2364026, luke.lawson@okstate.edu
About this study
This study investigates a new delivery method for the General Anxiety Disorder - 7 (GAD 7), a clinically accepted tool for diagnosing general anxiety disorder. The new tool records auditory responses to the assessment 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 the construct validity and user experience of a new delivery system for the General Anxiety Disorder - 7 (GAD 7), a clinically accepted tool for diagnosing general anxiety disorder. The purpose of the study is to examine if the new delivery system of the GAD 7 is effective at capturing participant anxiety levels and to assess the differences of usability between the paper and voice administered versions. The voice administered version uses a Mirror device, which is similar to a smart television with a mirror interface. The device records auditory responses to the GAD 7 through Amazon Alexa. The investigators will be comparing the responses on the new 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
- General Anxiety Disorder
- Being tested
- Paper GAD 7, Voice Administered GAD 7
- Medical subject headings
- Generalized Anxiety Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paper GAD 7Diagnostic test
Also called Clinically Accepted Paper GAD 7
The paper based GAD 7 that is commonly accepted at clinics
Voice Administered GAD 7Diagnostic test
Also called Alexa GAD 7, Mirror GAD 7
This is the voice based GAD 7 that is administered through a Mirror device equipped with Amazon Alexa software.
| Study group | Role | What they receive |
|---|---|---|
| Paper Baseline | Experimental | Half of the participants will complete the GAD 7 in the traditional paper format at their first appointment. At their second appointment 1-month later, they will complete the GAD 7 on the Mirror device equipped with Amazon Alexa. Receives: Diagnostic Test: Paper GAD 7; Diagnostic Test: Voice Administered GAD 7 |
| Alexa Baseline | Experimental | The other half of the participants will complete the GAD 7 on the Mirror device equipped with Amazon in the traditional paper format at their first appointment. At their second appointment 1-month later, they will complete the GAD 7 in the traditional paper format. Receives: Diagnostic Test: Paper GAD 7; Diagnostic Test: Voice Administered GAD 7 |
What is being measured
The primary outcome is the main question the study is designed to answer.
GAD 7 Diagnostic Scores
Scores from the self administered assessment for general anxiety disorder
Measured: Five minutes
User Experience Questionnaire
Likert based questionnaire on user experience
Measured: Five minutes
Secondary outcomes (1)
Patient's Qualitative Responses
Comments from patient on usability of the device
Measured: One minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2021
- Study start10 Jun 2021
- Primary completion31 May 2022 (estimated)
- Study completion15 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for General Anxiety 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., GAD 7 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
- NCT04990492
- Sponsor's protocol ID
- 2021029
- Status last verified
- Apr 2022
- First submitted
- 6 Jul 2021
- Last updated
- 21 Apr 2022
- 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 21 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interactive Voice Based Administration of the GAD 7
- ClinicalTrials.gov ID
- NCT04990492
- Acronym / sponsor ID
- 2021029
- Conditions
- General Anxiety 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
- 10 Jun 2021 (actual)
- Primary completion
- 31 May 2022 (estimated)
- Study completion
- 15 Jun 2022 (estimated)
- First posted
- 4 Aug 2021 (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 General Anxiety Disorder - 7 (GAD 7), a clinically accepted tool for diagnosing general anxiety disorder. The new tool records auditory responses to the assessment 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 the construct validity and user experience of a new delivery system for the General Anxiety Disorder - 7 (GAD 7), a clinically accepted tool for diagnosing general anxiety disorder. The purpose of the study is to examine if the new delivery system of the GAD 7 is effective at capturing participant anxiety levels and to assess the differences of usability between the paper and voice administered versions. The voice administered version uses a Mirror device, which is similar to a smart television with a mirror interface. The device records auditory responses to the GAD 7 through Amazon Alexa. The investigators will be comparing the responses on the new 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., GAD 7 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: Paper GAD 7, Diagnostic Test: Voice Administered GAD 7Half of the participants will complete the GAD 7 in the traditional paper format at their first appointment. At their second appointment 1-month later, they will complete the GAD 7 on the Mirror device equipped with Amazon Alexa. |
| Alexa Baseline | Experimental | Diagnostic Test: Paper GAD 7, Diagnostic Test: Voice Administered GAD 7The other half of the participants will complete the GAD 7 on the Mirror device equipped with Amazon in the traditional paper format at their first appointment. At their second appointment 1-month later, they will complete the GAD 7 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 |
|---|---|---|
| Paper GAD 7Also: Clinically Accepted Paper GAD 7The paper based GAD 7 that is commonly accepted at clinics | Diagnostic test | Alexa Baseline, Paper Baseline |
| Voice Administered GAD 7Also: Alexa GAD 7, Mirror GAD 7This is the voice based GAD 7 that is administered through a Mirror device equipped with Amazon Alexa software. | Diagnostic test | Alexa Baseline, Paper Baseline |
Primary outcome
GAD 7 Diagnostic Scores
Time frame: Five minutes
Scores from the self administered assessment for general anxiety disorder
User Experience Questionnaire
Time frame: Five minutes
Likert based questionnaire on user experience
1 secondary outcome
Patient's Qualitative Responses
Time frame: One minute
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2022.
- Individual participant dataSharing planned: No. Aggregate data and findings will be posted on ClinicalTrials.gov.
Related trials for General Anxiety Disorder
Not yet recruitingPhase 1
Microbiota Modulation for Psychiatry Patients
Depression - Major Depressive Disorder, Generalized Anxiety Disorder (GAD)
RecruitingPhase 3
A Trial of the Efficacy and Safety of Fixed Doses of SEP-363856 in Adults With Generalized Anxiety Disorder
Generalized Anxiety Disorder
Recruiting
Electroacupuncture for Generalized Anxiety Disorder: Clinical Efficacy and Neuroimaging Mechanisms
Generalized Anxiety Disorder
Not yet recruiting
Miles for Mental Health
Generalized Anxiety Disorder (GAD), Depressive and Anxiety Disorders
RecruitingObservational study
Preoperative Anxiety and One-year Patient-reported Outcomes in Orthopedic Surgery Patients Receiving Enhanced Recovery After Surgery or Conventional Care
Preoperative Anxiety, Orthopedic Surgery
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 Paper GAD 7 and Voice Administered GAD 7 in people with General Anxiety 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 21 Apr 2022. 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?
GAD 7 Diagnostic Scores (time frame: Five minutes). 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 21 Apr 2022.