Interactive Voice Based Administration of the GAD 7

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.

Study Overview

• Status: Recruiting
• Conditions: General Anxiety Disorder
• Intervention / Treatment: Diagnostic test: Paper GAD 7; Diagnostic test: Voice Administered GAD 7

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 Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oklahoma
    • Tulsa, Oklahoma, United States, 75135
      • Recruiting
      • OSU Behavioral Health Clinic
      • Contact: Luke Lawson, M.A.; Phone Number: 918-2364026; Email: luke.lawson@okstate.edu

Participation Criteria

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

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
GAD 7 Diagnostic Scores	Scores from the self administered assessment for general anxiety disorder	Five minutes
User Experience Questionnaire	Likert based questionnaire on user experience	Five minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient's Qualitative Responses	Comments from patient on usability of the device	One minute

Collaborators and Investigators

• Sponsor: Oklahoma State University Center for Health Sciences
• Collaborators: Oral Roberts University

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2021
• Primary Completion (Anticipated): May 31, 2022
• Study Completion (Anticipated): June 15, 2022

Study Registration Dates

• First Submitted: July 6, 2021
• First Submitted That Met QC Criteria: July 26, 2021
• First Posted (Actual): August 4, 2021

Study Record Updates

• Last Update Posted (Actual): April 21, 2022
• Last Update Submitted That Met QC Criteria: April 19, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: 2021029

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