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Interactive Voice Based Administration of the GAD 7

Sponsor
Oklahoma State University Center for Health Sciences (Other)
Overall Status
Recruiting
CT.gov ID
NCT04990492
Collaborator
Oral Roberts University (Other)
40
Enrollment
1
Location
2
Arms
12.2
Anticipated Duration (Months)
3.3
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Paper GAD 7
  • Diagnostic Test: Voice Administered GAD 7
 N/A

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 Design

Study Type:
Interventional
Anticipated 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.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 :
Jun 10, 2021
Anticipated Primary Completion Date :
May 31, 2022
Anticipated Study Completion Date :
Jun 15, 2022

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. GAD 7 Diagnostic Scores [Five minutes]

      Scores from the self administered assessment for general anxiety disorder

    2. User Experience Questionnaire [Five minutes]

      Likert based questionnaire on user experience

    Secondary Outcome Measures

    1. Patient's Qualitative Responses [One minute]

      Comments from patient on usability of the device

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 OSU Behavioral Health Clinic Tulsa Oklahoma United States 75135

    Sponsors and Collaborators

    • Oklahoma State University Center for Health Sciences
    • Oral Roberts University

    Investigators

    • Principal Investigator: Jason Beaman, D.O., Oklahoma State University Center for Health Sciences

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Oklahoma State University Center for Health Sciences
    ClinicalTrials.gov Identifier:
    NCT04990492
    Other Study ID Numbers:
    • 2021029
    First Posted:
    Aug 4, 2021
    Last Update Posted:
    Apr 21, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Anxiety Disorders

    Study Results

    No Results Posted as of Apr 21, 2022