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Effectiveness of eye-contact training devices for social anxiety disorder: a pilot study

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

23

Fourteen females and nine males participants, aged 18 to 55 years (median:24 years old),were recruited. The average total score of the Liebowitz Social Anxiety Scale (LSAS) was 81 points (SD = 17.3), and all had moderate or higher social anxiety (LSAS total score of 50 points). The average LSAS anxiety score was 44 points (SD = 10.7), and the average LSAS avoidance score was 37 points (SD = 7.7). Seventeen were taking some psychotropic drug. No one changed their medication during the intervention period.

Registration progress was almost on schedule.Twenty-three of the 24 participants completed the intervention specified in the protocol, and one dropped out before the intervention at the request of the participants. According to the protocol, the largest analysis population (FAS) was 23 individuals who received at least one device intervention. In addition, the target population (PPS) that conformed to the study protocol was 23 patients who received 6 or more eye contact trainings and did not find any violations of selection criteria, exclusion criteria, or combination-prohibited therapy.

One of the participants experienced an adverse event (two dry eyes), which resolved spontaneously in 10-20 minutes. No serious adverse events occurred.

The primary endpoint was the change in LSAS total score at the end of training (Visit 8) from baseline (Visit 0), and we tested whether the LSAS total score significantly decreased after the intervention. The results showed a statistically significant decrease in LSAS total scores after the intervention, with a mean of -27.5 points (95% confidence interval -19.7 to -35.4) (p<0.0001). In addition, the following results were obtained for the secondary endpoints. (1) The change from baseline (Visit 0) in LSAS total score at Visit 4 and Visit 9 were statistically significant with a mean of -15.70 points (95% CI -22.09 to -9.30, p<0.0001) and -36.18 points (95% CI -44.90 to -27.37, p<0.001). (2) The change in SPIN-J total score from baseline (Visit 0) at Visit 4 was statistically not significant with a mean of -2.30 points (95% CI -5.63 to1.02, p=0.17). In Visit 8 and Visit 9, there were statistically significant with a mean of -8.70 points (95%CI -13.19 to -4.20, p<0.001), -12.32 points (95%CI -18.04 to -6.59, p<0.005). (3) The change in PHQ-9 total score from baseline (Visit 0) at Visit4 was statistically not significant with a mean of -0.43 points (95%CI -2.56 to -1.69, p=0.68). In Visit8 and Visit9, there were statistically significant with a mean of -3.39 points (95%CI -5.42 to -1.36, p<0.005) , mean of -3.86 points (95%CI -6.47 to -1.26, p<0.006) . (4) The change in GAD-7 total score from baseline (Visit 0) at Visit4, In Visit 8 and Visit9, there were statistically significant with a mean of -1.61 points (95%CI -10.0 to 3.00, p<0.05). mean of 3.78 points (95%CI -5.57 to -2.00, p<0.005), mean of -3.64 (95%CI -6.04 to -1.23, p<0.005) (5) The change in EQ5D QOL score from baseline (Visit 0) at Visit4 was statistically not significant with a mean of 0.03 points (95%CI -0.01 to 0.07, p=0.1). In Visit 8 and Visit9, there were statistically significant with a mean of 0.05 points (95%CI 0.01 to 0.09, p<0.01) mean of 0.08 points (95%CI 0.02 to 0.13, p<0.006). (6A) The change in anxiety in eye-contact score from baseline (Visit 0) at Visit4, Visit 8 and Visit9 were statistically significant with a mean of -14.00 points (95%CI -25.82 to -2.18, p<0.005) , mean of 24.48 points (95%CI -39.09 to -9.86, p<0.005) , mean of -26.50 points (95%CI -39.70 to -13.93, p<0.0005). (6B) The mean change from baseline (Visiit0) in fun of eye-contact at Visit4 and Visit8 were statistically not significant with a mean of 9.40 points (95%CI -3.33 to 22.13. p=0.14), mean of 9.25 points (95%CI -5.91 to 24.41, p=0.22). (7A) The change in delight of training feedback score from Visit1 at Visit4 and Visit 8 were statistically significant with a mean of 0.48 points (95%CI 0.03 to 0.93, p<0.05), mean of 0.83 points (95%CI 0.36 to 1.29, p<0.005). (7B) The change in usability of glasses-type device score from Visit1 at Visit4 was statistically not significant with a mean of 0.39 points (95%CI -0.06 to 0.84, p=0.08) . In Visit 8, there was statistically significant with a mean of 0.65 points (95% CI 0.19 to 1.12) (p<0.05). (7C) The change in degree of recommending eye-contact training score from Visit1 at Visit4 was statistically not significant with a mean of 0.26 points (95%CI-0.04 to 0.56, p=0.08). In Visit8, there was statistically significant with a mean of 0.43 (95%CI 0.15 to 0.72, p<0.005).

Twenty-three subjects with social anxiety disorder underwent eight sessions of eye-contact training using a spectacle-shaped device. The primary endpoint, the LSAS total score, decreased significantly after the intervention. The secondary endpoints, SPIN-J, PHQ-9, GAD-7, and EQ-5D, also improved significantly after the intervention. Eye-contact training with a device may be an effective treatment for social anxiety.

Dec. 31, 2023

No

None

https://jrct.niph.go.jp/latest-detail/jRCTs032200213

Shimizu Eiji

Chiba University Hospital

1-8-1 Inohana, Chuo-ku, Chiba, Japan

eiji@faculty.chiba-u.jp

Matsumoto Junko

Chiba University

1-8-1 Inohana, Chuo-ku, Chiba, Japan

+81-43-226-2027

matsujun@chiba-u.jp

Complete

Nov. 24, 2020

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

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.

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

Both

Social anxiety disorder

Eye-contact training

D000072861

D046650

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

(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

+81-43-222-7171

May. 20, 2020

none