Evaluating the Validity and Acceptability of a Fully-automated Interview to Diagnose Insomnia Disorder: a Pilot Study

Completed

• Conditions: Insomnia Disorder

• Registration Number: NCT05805527
• Lead Sponsor: University of Bordeaux

Brief Summary

Objective: to evaluate if a fully-automated diagnostic interview for insomnia disorder is suitable for clinical and research purposes (adequate sensitivity and specificity) and is acceptable to patients.

Study main outcomes:

1. Concurrent validity (sensitivity and specificity) compared to a gold standard. Gold standard: clinical diagnosis of a clinician using a validated structured clinical interview for the DSM 5 criteria of insomnia disorder

2. Acceptability of the fully-automated interview.

Participants:

Volunteers to undergo the clinical and the automated interview will be recruited through non-probability convenience sampling from patients attending the sleep clinic at Bordeaux University Hospital between May 2023 and July 2023.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-27
• Study First Submitted QC: 2023-03-27
• Study First Posted: 2023-04-10
• Study Start: 2023-05-01
• Primary Completion: 2023-07-31
• Study Completion: 2023-08-30
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-30
• Last Update Posted: 2023-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

• Aged 18 years or older
• Being able to communicate and read in French
• Previous use a mobile phone

Exclusion Criteria

• N/A

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Concurrent validity (sensitivity and specificity)	May-July 2023	Calculated with a gold standard evaluation consisting of the clinical diagnosis of a clinician using a validated structured clinical interview for the DSM 5 criteria of insomnia disorder

Secondary Outcome Measures

Name	Time	Method
Acceptability of the fully-automated interview	May-July 2023	It will be measured with the Acceptability E-Scale (AES), that comprises six items and provides a total score as well as two subscores regarding usability (i.e. the perceived ease of using the system) and satisfaction with the system. Items are answered on a five-point Likert-type scale ranging from 1: Very unsatisfied, to 5: Very satisfied. Therefore, higher scores connote better acceptability.
Perceptions of the virtual agent	May-July 2023	It will be measured with the ECA-Trust Questionnaire (ETQ), that includes six items that are answered on a four-point Likert-type scale ranging from 0: Not at all, to 3: Totally agree. It provides a total score as well as subscores on two separate dimensions, named perceived credibility and perceived benevolence of the virtual agent conducting the digital interview. Higher scores connote more trust.

Trial Locations

Locations (1)

University Hospital of Bordeaux; 🇫🇷 Bordeaux, France