A study of eye-contact training devices (ECOM: Eye CommunicationTrainer) for social anxiety disorder

JRCT ID: jRCTs032200213

Registered date:24/11/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Social anxiety disorder
• Date of first enrollment: 24/11/2020
• Target sample size: 24
• Study type: Interventional
• Intervention(s): Eye-contact training

Outcome(s)

• Primary Outcome: Mean change from baseline in Liebowitz Social Anxiety Scale Score (Time Frame: baseline, 8 visits)

Secondary Outcome

(1)Mean change from baseline in Liebowitz Social Anxiety Scale Score (Time Frame: baseline, 4 visits and 9 visits) (Structured interview by an assessor)

Mean change from baseline to 4 visits, 8 visits and 9 visits
(2) Social Phobia Inventory score
(3) Patient Health Questionnaire-9 score
(4) Generalized Anxiety Disorder-7 score
(5) EuroQol 5 Dimension score

Mean change from baseline to each point of 1-8 visits and 9 visits
(6) Visual Analogue Scale score (Evaluate from 0 to 100 points, Before and after the training of each visit)
A. Anxiety in eye-contact
B. Fun of eye-contact

Mean change from 1 visit to each point of 2-8 visits Self-Reported Questionnaire(5 likert scale)
(7)Evaluation scale
A. Delight of training feedback
B. Usability of glasses-type device
C. Degree of recommending eye-contact training

(8) Free description
Free description including "fun scene" and "scenes I'm not good at"

(9)Name of psychotropic drug and daily dose

<Exploratory outcomes>
1)Number of eye-contact detections, eye-contact detection time, number of feedbacks
2)Heart rate(using wearable measuring instrument) and heart rate variability index (low--frequency, high-frequency, ratio of LF and HF)(Data is acquired only when patient consent to measure)
3)Left pupil diameter and right pupil diameter
4)Number of blinks
<Seconfary outcome of safety>
Presence or absence of adverse events

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 65age old
• Gender: Both

Include criteria

1)Primary diagnosis of social anxiety disorder using the Mini- International Neuropsychiatric Interview, DSM-5.
2)The age between 18 to 65.
3)Patients with full consent of participation in the study.
4)Patients who have a total LSAS score of 50 points or more
5)No change of medical drugs during the study though the medication of social anxiety disorder is not considered.
6)Possible to understand eye contact training and has mental and physical condition that can be participate the session for at least 16 weeks.
7)If social anxiety disorder is primary diagnosed, patients with autism spectrum disorder will not be excluded from the study.

Exclude criteria

1)Patients who have organic brain disorder (including dementia), psychosis, bipolar disorder, substance abuse or dependence, other severe mental disorders.
2)Active suicidality
3)Repetitive anti-social behavior
4)Severe physical condition
5)IQ under 80 by evaluating the JART25 (Japanese Adult Reading Test25)
6)Patients who cannot contact with the study organizer
7)Patients who are hard to see or hear during the study.
8)Other relevant reason decided by the investigators

Related Information

• Primary Sponsor: Shimizu Eiji
• Source(s) of Monetary Support: Sumitomo Dainippon Pharma Co., Ltd.