NCT04990492

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 10, 2021

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

July 6, 2021

Completed
29 days until next milestone

First Posted

Study publicly available on registry

August 4, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2022

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2022

Completed
Last Updated

April 21, 2022

Status Verified

April 1, 2022

Enrollment Period

12 months

First QC Date

July 6, 2021

Last Update Submit

April 19, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • Patient's Qualitative Responses

    One minute

Study Arms (2)

Paper Baseline

EXPERIMENTAL

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 7Diagnostic Test: Voice Administered GAD 7

Alexa Baseline

EXPERIMENTAL

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 7Diagnostic Test: Voice Administered GAD 7

Interventions

Paper GAD 7DIAGNOSTIC_TEST

The paper based GAD 7 that is commonly accepted at clinics

Also known as: Clinically Accepted Paper GAD 7
Alexa BaselinePaper Baseline

This is the voice based GAD 7 that is administered through a Mirror device equipped with Amazon Alexa software.

Also known as: Alexa GAD 7, Mirror GAD 7
Alexa BaselinePaper Baseline

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Newly admitted patients to the Oklahoma State University Behavioral Medicine Clinic

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

OSU Behavioral Health Clinic

Tulsa, Oklahoma, 75135, United States

RECRUITING

MeSH Terms

Conditions

Generalized Anxiety Disorder

Condition Hierarchy (Ancestors)

Anxiety DisordersMental Disorders

Study Officials

  • Jason Beaman, D.O.

    Oklahoma State University Center for Health Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jason Beaman, D.O.

CONTACT

Luke Lawson, M.A.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2021

First Posted

August 4, 2021

Study Start

June 10, 2021

Primary Completion

May 31, 2022

Study Completion

June 15, 2022

Last Updated

April 21, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Aggregate data and findings will be posted on ClinicalTrials.gov.

Locations