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Interactive Voice Based Administration of the GAD 7

Primary Purpose

General Anxiety Disorder

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Paper GAD 7
Voice Administered GAD 7
Sponsored by
Oklahoma State University Center for Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for General Anxiety Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • OSU Behavioral Health ClinicRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Paper Baseline

Alexa Baseline

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

GAD 7 Diagnostic Scores
Scores from the self administered assessment for general anxiety disorder
User Experience Questionnaire
Likert based questionnaire on user experience

Secondary Outcome Measures

Patient's Qualitative Responses
Comments from patient on usability of the device

Full Information

First Posted
July 6, 2021
Last Updated
April 19, 2022
Sponsor
Oklahoma State University Center for Health Sciences
Collaborators
Oral Roberts University
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1. Study Identification

Unique Protocol Identification Number
NCT04990492
Brief Title
Interactive Voice Based Administration of the GAD 7
Official Title
Interactive Voice Based Administration of the GAD 7
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 10, 2021 (Actual)
Primary Completion Date
May 31, 2022 (Anticipated)
Study Completion Date
June 15, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oklahoma State University Center for Health Sciences
Collaborators
Oral Roberts University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
General Anxiety Disorder

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Paper Baseline
Arm Type
Experimental
Arm Description
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.
Arm Title
Alexa Baseline
Arm Type
Experimental
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Paper GAD 7
Other Intervention Name(s)
Clinically Accepted Paper GAD 7
Intervention Description
The paper based GAD 7 that is commonly accepted at clinics
Intervention Type
Diagnostic Test
Intervention Name(s)
Voice Administered GAD 7
Other Intervention Name(s)
Alexa GAD 7, Mirror GAD 7
Intervention Description
This is the voice based GAD 7 that is administered through a Mirror device equipped with Amazon Alexa software.
Primary Outcome Measure Information:
Title
GAD 7 Diagnostic Scores
Description
Scores from the self administered assessment for general anxiety disorder
Time Frame
Five minutes
Title
User Experience Questionnaire
Description
Likert based questionnaire on user experience
Time Frame
Five minutes
Secondary Outcome Measure Information:
Title
Patient's Qualitative Responses
Description
Comments from patient on usability of the device
Time Frame
One minute

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jason Beaman, D.O.
Phone
918-561-8269
Email
jason.beaman@okstate.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Luke Lawson, M.A.
Phone
915-241-5853
Email
luke.lawson@okstate.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jason Beaman, D.O.
Organizational Affiliation
Oklahoma State University Center for Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
OSU Behavioral Health Clinic
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
75135
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jason Beaman, D.O.
Phone
918-561-8269
Email
jason.beaman@okstate.edu
First Name & Middle Initial & Last Name & Degree
Luke Lawson, M.A.
Phone
918-2364026
Email
luke.lawson@okstate.edu

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Aggregate data and findings will be posted on ClinicalTrials.gov.

Learn more about this trial

Interactive Voice Based Administration of the GAD 7

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