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Interactive Voice Based Administration of the GAD 7

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04990492
Recruitment Status : Recruiting
First Posted : August 4, 2021
Last Update Posted : April 21, 2022
Sponsor:
Collaborator:
Oral Roberts University
Information provided by (Responsible Party):
Oklahoma State University Center for Health Sciences

Brief 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. If proven effective, future studies may investigate if the new format can be used to improve at home clinical care.

Condition or disease Intervention/treatment Phase
General Anxiety Disorder Diagnostic Test: Paper GAD 7 Diagnostic Test: Voice Administered GAD 7 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
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., 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)
Primary Purpose: Diagnostic
Official Title: Interactive Voice Based Administration of the GAD 7
Actual Study Start Date : June 10, 2021
Estimated Primary Completion Date : May 31, 2022
Estimated Study Completion Date : June 15, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: Paper Baseline
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.
Diagnostic Test: Paper GAD 7
The paper based GAD 7 that is commonly accepted at clinics
Other Name: Clinically Accepted Paper GAD 7

Diagnostic Test: Voice Administered GAD 7
This is the voice based GAD 7 that is administered through a Mirror device equipped with Amazon Alexa software.
Other Names:
  • Alexa GAD 7
  • Mirror GAD 7

Experimental: Alexa Baseline
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.
Diagnostic Test: Paper GAD 7
The paper based GAD 7 that is commonly accepted at clinics
Other Name: Clinically Accepted Paper GAD 7

Diagnostic Test: Voice Administered GAD 7
This is the voice based GAD 7 that is administered through a Mirror device equipped with Amazon Alexa software.
Other Names:
  • Alexa GAD 7
  • Mirror GAD 7




Primary Outcome Measures :
  1. GAD 7 Diagnostic Scores [ Time Frame: Five minutes ]
    Scores from the self administered assessment for general anxiety disorder

  2. User Experience Questionnaire [ Time Frame: Five minutes ]
    Likert based questionnaire on user experience


Secondary Outcome Measures :
  1. Patient's Qualitative Responses [ Time Frame: One minute ]
    Comments from patient on usability of the device



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04990492


Contacts
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Contact: Jason Beaman, D.O. 918-561-8269 jason.beaman@okstate.edu
Contact: Luke Lawson, M.A. 915-241-5853 luke.lawson@okstate.edu

Locations
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United States, Oklahoma
OSU Behavioral Health Clinic Recruiting
Tulsa, Oklahoma, United States, 75135
Contact: Jason Beaman, D.O.    918-561-8269    jason.beaman@okstate.edu   
Contact: Luke Lawson, M.A.    918-2364026    luke.lawson@okstate.edu   
Sponsors and Collaborators
Oklahoma State University Center for Health Sciences
Oral Roberts University
Investigators
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Principal Investigator: Jason Beaman, D.O. Oklahoma State University Center for Health Sciences
  Study Documents (Full-Text)

Documents provided by Oklahoma State University Center for Health Sciences:
Informed Consent Form  [PDF] April 22, 2021

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Responsible Party: Oklahoma State University Center for Health Sciences
ClinicalTrials.gov Identifier: NCT04990492    
Other Study ID Numbers: 2021029
First Posted: August 4, 2021    Key Record Dates
Last Update Posted: April 21, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Aggregate data and findings will be posted on ClinicalTrials.gov.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Anxiety Disorders
Mental Disorders