Interactive Voice Based Administration of the GAD 7

NCT ID: NCT04990492

Last Updated: 2022-04-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-10

Study Completion Date

2022-06-15

Brief Summary

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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

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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.

Conditions

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General Anxiety Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Paper GAD 7

Intervention Type DIAGNOSTIC_TEST

The paper based GAD 7 that is commonly accepted at clinics

Voice Administered GAD 7

Intervention Type DIAGNOSTIC_TEST

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

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.

Group Type EXPERIMENTAL

Paper GAD 7

Intervention Type DIAGNOSTIC_TEST

The paper based GAD 7 that is commonly accepted at clinics

Voice Administered GAD 7

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Paper GAD 7

The paper based GAD 7 that is commonly accepted at clinics

Intervention Type 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.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Clinically Accepted Paper GAD 7 Alexa GAD 7 Mirror GAD 7

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Oral Roberts University

UNKNOWN

Sponsor Role collaborator

Oklahoma State University Center for Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jason Beaman, D.O.

Role: PRINCIPAL_INVESTIGATOR

Oklahoma State University Center for Health Sciences

Locations

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OSU Behavioral Health Clinic

Tulsa, Oklahoma, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Jason Beaman, D.O.

Role: CONTACT

918-561-8269

Luke Lawson, M.A.

Role: CONTACT

915-241-5853

Facility Contacts

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Jason Beaman, D.O.

Role: primary

918-561-8269

Luke Lawson, M.A.

Role: backup

918-2364026

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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2021029

Identifier Type: -

Identifier Source: org_study_id

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