Interactive Voice Based Administration of the GAD 7 | NCT04990492

Studies
Interactive Voice Based Administration of the GAD 7

NCT04990492

Sponsor

Oklahoma State University Center for Health Sciences

Status

Unknown status

Last Update Posted

Apr 21, 2022Actual

Enrollment

40Estimated

Phase

Not Applicable

Conditions

General Anxiety Disorder

Interventions

Paper GAD 7
Voice Administered GAD 7

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 10, 2021Actual

Primary Completion Date

May 31, 2022Estimated

Completion Date

Jun 15, 2022Estimated

First Submitted Date

Jul 6, 2021

First Submission Date that Met QC Criteria

Jul 26, 2021

First Posted Date

Aug 4, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 19, 2022

Last Update Posted Date

Apr 21, 2022Actual

Name	Class
Oral Roberts University	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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 7 Diagnostic 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 7 Diagnostic Test: Voice Administered GAD 7

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Paper GAD 7	Diagnostic Test	The paper based GAD 7 that is commonly accepted at clinics	Alexa Baseline Paper Baseline

Outcomes Module

Primary Outcomes

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 Outcomes

Measure	Description	Time Frame
Patient's Qualitative Responses	Comments from patient on usability of the device	One minute

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jason Beaman, D.O.	Contact	918-561-8269		jason.beaman@okstate.edu
Luke Lawson, M.A.	Contact	915-241-5853		luke.lawson@okstate.edu

Overall Officials

Name	Affiliation	Role
Jason Beaman, D.O.	Oklahoma State University Center for Health Sciences	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
OSU Behavioral Health Clinic	Recruiting	Tulsa	Oklahoma	75135	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

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

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
ICF	No	No	Yes	Informed Consent Form	Apr 22, 2021	Jun 24, 2021	ICF_000.pdf

Condition Browse Module

MeSH Terms

ID	Term
D000098647	Generalized Anxiety Disorder

Ancestor Terms

ID	Term
D001008	Anxiety Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

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.