Interactive Voice Based Administration of the GAD 7

Study Overview
=================
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.

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.

Official Title
-----------------
Interactive Voice Based Administration of the GAD 7

Conditions
-----------------
General Anxiety Disorder

Intervention / Treatment
-----------------
* Diagnostic Test: Paper GAD 7
* Diagnostic Test: Voice Administered GAD 7


Participation Criteria
=================
Eligibility 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Paper Baseline<br>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<br>* The paper based GAD 7 that is commonly accepted at clinics<br>* Other names: Clinically Accepted Paper GAD 7;Diagnostic Test: Voice Administered GAD 7<br>* This is the voice based GAD 7 that is administered through a Mirror device equipped with Amazon Alexa software.<br>* Other names: Mirror GAD 7;|
| Experimental: Alexa Baseline<br>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<br>* The paper based GAD 7 that is commonly accepted at clinics<br>* Other names: Clinically Accepted Paper GAD 7;Diagnostic Test: Voice Administered GAD 7<br>* This is the voice based GAD 7 that is administered through a Mirror device equipped with Amazon Alexa software.<br>* Other names: 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 |