Clinical trial NCT04990492: Interactive Voice Based Administration of the GAD 7
Official title: Interactive Voice Based Administration of the GAD 7
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: General Anxiety Disorder
Lead sponsor: Oklahoma State University Center for Health Sciences
Sponsor class: OTHER
Collaborators: name: Oral Roberts University
First posted: 2021-08-04
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: DIAGNOSTIC

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.

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.

Primary outcomes:
measure: GAD 7 Diagnostic Scores
timeFrame: Five minutes
measure: User Experience Questionnaire
timeFrame: Five minutes
Secondary outcomes:
measure: Patient's Qualitative Responses
timeFrame: One minute
Other outcomes:
Locations:
city: Tulsa
country: United States
facility: OSU Behavioral Health Clinic
state: Oklahoma
Study officials:
affiliation: Oklahoma State University Center for Health Sciences
name: Jason Beaman, D.O.
role: PRINCIPAL_INVESTIGATOR
References: