Interactive Voice Based Administration of the GAD 7

General Anxiety Disorder Clinical Trial

Official title:

Interactive Voice Based Administration of the GAD 7

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04990492
• Other study ID #: 2021029
• Status: Recruiting
• Phase: N/A
• Start date: June 10, 2021
• Est. completion date: June 15, 2022

Study information

• Verified date: April 2022
• Source: Oklahoma State University Center for Health Sciences
• Contact: Jason Beaman, D.O.
• Phone: 918-561-8269
• Email: jason.beaman[@]okstate.edu
• Is FDA regulated: No
• Study type: Interventional

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 15, 2022
• Est. primary completion date: May 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety Disorders
• General Anxiety Disorder

Intervention

Diagnostic Test:
• Paper GAD 7
The paper based GAD 7 that is commonly accepted at clinics
• Voice Administered GAD 7
This is the voice based GAD 7 that is administered through a Mirror device equipped with Amazon Alexa software.

Locations

Country	Name	City	State
United States	OSU Behavioral Health Clinic	Tulsa	Oklahoma

Sponsors (2)

Lead Sponsor	Collaborator
Oklahoma State University Center for Health Sciences	Oral Roberts University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	GAD 7 Diagnostic Scores	Scores from the self administered assessment for general anxiety disorder	Five minutes
Primary	User Experience Questionnaire	Likert based questionnaire on user experience	Five minutes
Secondary	Patient's Qualitative Responses	Comments from patient on usability of the device	One minute