JMIR FORMATIVE RESEARCH

Yoshinaga et al

Original Paper

Preliminary Evaluation of Translated and Culturally AdaptedInternet-Delivered Cognitive Therapy for Social Anxiety Disorder:
Multicenter, Single-Arm Trial in Japan
Naoki Yoshinaga1, RN, PhD; Graham R Thew2,3, DClinPsy, DPhil; Yuta Hayashi4, RN, PhD; Jun Matsuoka5,6, MD,
PhD; Hiroki Tanoue1, RN, PhD; Rieko Takanashi7,8, PhD; Mutsumi Araki9, MEd; Yoshihiro Kanai10, PhD; Alisha
Smith11, BA; Sophie H L Grant2, MSc; David M Clark2, DPhil
1

School of Nursing, Faculty of Medicine, University of Miyazaki, Miyazaki, Japan2

Department of Experimental Psychology, University of Oxford, Oxford, United Kingdom

3

Oxford Health NHS Foundation Trust, Oxford, United Kingdom

4Department of Nursing, Graduate School of Health Sciences, Kobe University, Kobe, Japan

5

Higashi-Omiya Mental Health Clinic, Saitama, Japan6

Ogu Mental Health Clinic, Tokyo, Japan

7

Department of Psychology, Teikyo University, Tokyo, Japan

8

Research Center for Child Mental Development, Chiba University, Chiba, Japan

9

Gokiso Counseling Office, Nagoya, Japan10

Department of Psychology and Behavioral Sciences, Faculty of Human Sciences, Tohoku Gakuin University, Sendai, Japan

11

School of Psychology, Cardiff University, Cardiff, United Kingdom

Corresponding Author:
Naoki Yoshinaga, RN, PhD
School of Nursing
Faculty of Medicine
University of Miyazaki
5200 Kihara
Kiyotake
Miyazaki, 889-1692
Japan
Phone: 81 985 85 9784
Email: naoki-y@med.miyazaki-u.ac.jp

Abstract
Background: Internet-delivered cognitive therapy for social anxiety disorder (iCT-SAD), which is a therapist-guided modular
web-based treatment, has shown strong efficacy and acceptability in English-language randomized controlled trials in the United
Kingdom and Hong Kong. However, it is not yet known whether iCT-SAD can retain its efficacy following linguistic translationand cultural adaptation of treatment contents and implementation in other countries such as Japan.
Objective: This study aimed to examine the preliminary efficacy and acceptability of the translated and culturally adapted
iCT-SAD in Japanese clinical settings.
Methods: This multicenter, single-arm trial recruited 15 participants with social anxiety disorder. At the time of recruitment,
participants were receiving usual psychiatric care but had not shown improvement in their social anxiety and required additional
treatment. iCT-SAD was provided in combination with usual psychiatric care for 14 weeks (treatment phase) and for a subsequent
3-month follow-up phase that included up to 3 booster sessions. The primary outcome measure was the self-report version of the
Liebowitz Social Anxiety Scale. The secondary outcome measures examined social anxiety–related psychological processes,
taijin kyofusho (the fear of offending others), depression, generalized anxiety, and general functioning. The assessment points
for the outcome measures were baseline (week 0), midtreatment (week 8), posttreatment (week 15; primary assessment point),
and follow-up (week 26). Acceptability was measured using the dropout rate from the treatment, the level of engagement withthe program (the rate of module completion), and participants’ feedback about their experience with the iCT-SAD.

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Results: Evaluation of the outcome measures data showed that iCT-SAD led to significant improvements in social anxiety
symptoms during the treatment phase (P<.001; Cohen d=3.66), and these improvements were maintained during the follow-up
phase. Similar results were observed for the secondary outcome measures. At the end of the treatment phase, 80% (12/15) ofparticipants demonstrated reliable improvement, and 60% (9/15) of participants demonstrated remission from social anxiety.
Moreover, 7% (1/15) of participants dropped out during treatment, and 7% (1/15) of participants declined to undergo the follow-up
phase after completing the treatment. No serious adverse events occurred. On average, participants completed 94% of the modules
released to them. Participant feedback was positive and highlighted areas of strength in treatment, and it included further suggestions
to improve suitability for Japanese settings.
Conclusions: Translated and culturally adapted iCT-SAD demonstrated promising initial efficacy and acceptability for Japaneseclients with social anxiety disorder. A randomized controlled trial is required to examine this more robustly.
(JMIR Form Res 2023;7:e45136) doi: 10.2196/45136
KEYWORDS
benchmarking; anxiety; social anxiety; social phobia; cognitive behavioral therapy; cognitive therapy; cross-cultural comparison;
Japan; mental disorders; internet-based intervention; mobile phone

Introduction
Background
Social anxiety disorder (SAD) is one of the most common
mental disorders, with an early age of onset, a typically chronic
course, and considerable impact on individuals’ quality of life[1]. These features lead to a large economic burden from asocietal perspective [2]. Individual face-to-face cognitive therapy(CT) and cognitive behavioral therapy (CBT) has consistently
been shown to be efficacious for SAD in a range of randomized
controlled trials [3]. It is recommended as the gold standard
psychological treatment in clinical practice guidelines in
multiple countries (eg, Canada, Germany, and Australia and
New Zealand) [4-6]. Guidelines from the United Kingdom [7]and Japan [8] specifically recommend individual CT based on
the Clark and Wells model or individual CBT based on the
Heimberg model, both of which have been uniquely developed
to understand and treat SAD [9,10]. Although it has been shownthat people with mental health problems tend to prefer
psychological treatment over pharmacotherapy [11], access toevidence-based face-to-face psychological treatments, including
CBT, remains limited worldwide [12]. This is particularly truein Japan, where SAD is prevalent [13] and the efficacy of
individual face-to-face CT for antidepressant-resistant SAD has
been demonstrated [14,15]. However, client’s access to CBTservices is severely limited, mainly because of the insufficientnumber of therapists [16,17].
Efforts to improve access to psychological treatments by training
new therapists have been made worldwide [18-22], but the
impact of expanded training can be improved further by applying
therapist-guided internet interventions. For both clients andtherapists, the main benefits of web-based psychologicaltreatments include flexibility, convenience, accessibility, andreduced therapist time per client, which can result in improved
treatment accessibility and sustainability [23]. These benefits
are also crucial during unpredictable natural disasters and publichealth emergencies, such as the COVID-19 pandemic, when
there are insufficient resources for and limited access to
professional mental health care.

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In the United Kingdom, internet-delivered CT for SAD(iCT-SAD) [24,25] has been developed as web-based
implementation of the face-to-face CT protocol that is basedon the Clark and Wells cognitive model [9]. The face-to-face
CT protocol has shown high efficacy in several randomized
controlled trials [15,26-29]. iCT-SAD is a therapist-guided
internet-delivered program, which follows a modular structure
and replicates the key treatment components of face-to-face
CT. The original English-language version of iCT-SAD showedstrong efficacy in the treatment of SAD across studies in the
United Kingdom and Hong Kong (within-group pre- to
posttreatment Cohen d effect sizes for social anxiety >1.6) and
was well accepted by clients (eg, dropout rates <10%)[24,25,30,31]. Randomized controlled trials indicated that
iCT-SAD was superior to waitlist control conditions [24,30]
and that clinical outcomes were comparable with that offace-to-face CT while requiring substantially less therapist time
per client [24]. The results from these trials also demonstrated
that the pre- and posttreatment effect sizes between the United
Kingdom and Hong Kong were similar, suggesting thepossibility of transporting iCT-SAD from one culture to anotherwithout substantial loss of efficacy. However, the trial conductedin Hong Kong used the English version of iCT-SAD without
modification of the treatment content and treated only
English-speaking residents in Hong Kong. Thus, it is still
unknown whether iCT-SAD can retain its high efficacy once
the treatment contents have been translated and adapted to adifferent culture.

Objective
To make iCT-SAD more suitable for the Japanese context, wetranslated and adapted the treatment content and materials fromEnglish to Japanese [32]. We initially translated andback-translated the treatment materials within iCT-SAD,
incorporating minor cultural adaptations where appropriate. The
Japanese treatment material was then evaluated using a guided
self-study approach with 6 Japanese SAD clients, where
electronic versions of the Japanese modules were emailed andused independently by clients between 14 weekly in-person
treatment sessions with their therapist. On the basis of the
feedback from participants and the positive clinical outcomes
observed in this guided self-study treatment (pre- to
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posttreatment Hedges g=2.31), it was concluded that theiCT-SAD treatment content was successfully translated andculturally adapted.

further confirmed the DSM-5 diagnostic classification made by
the psychiatrist and conducted a risk assessment interview.

In this study, we embedded the finalized treatment material intoa fully web-based Japanese iCT-SAD program. The main
objective was to examine the preliminary efficacy andacceptability of the translated and culturally adapted iCT-SAD
in Japanese clinical settings through a multicenter, single-arm,pre- to posttreatment study design. We also aimed to understandwhether the UK and Hong Kong findings [24,25,30,31] could
be replicated with the Japanese iCT-SAD program delivered toJapanese clients.

The participants received iCT-SAD in combination with usualcare. iCT-SAD is a therapist-guided internet intervention
developed in the United Kingdom [24,25] based on the Clark
and Wells cognitive model of SAD [9]. It implements allprocedures from the face-to-face CT-SAD protocol [26] in a
web-based format. iCT-SAD follows a modular structure,including 8 core modules that clients are encouraged to completein the first 2 weeks to promote engagement and motivation.
Thereafter, treatment is tailored to the individual concerns ofeach client using a range of specific modules covering common
fearful beliefs or problems.

Methods
Study Design
This study used a single-group pre- to posttreatment design.
Participant recruitment began in July 2021, and follow-up for
all participants was completed by November 2022.

Participants
A total of 15 participants with SAD were recruited from 5
medical institutions across Japan: the Fukunaga Internal and
Neuropsychiatry Clinic (Miyazaki), Wakakusa Hospital(Miyazaki), Higashi-Omiya Mental Health Clinic (Saitama),
Chiba University Hospital (Chiba), and Gokiso Mental Health
Clinic (Nagoya).
All participants were receiving usual psychiatric care at the timeof recruitment and had been doing so for an average of 11.6
(SD 12.1) months without substantial improvement in SAD
symptoms. Each participant, along with their psychiatrist, hadagreed that additional treatment was required. For participants’safety and risk monitoring, they were asked to continue theirregular appointments with their psychiatrist at their local medical
institution in addition to working on iCT-SAD with the study
therapist. We set this procedure because Japanese government
regulations and implementation guidelines require thattelemedicine be combined with regular face-to-face ambulatory
care.
The inclusion criteria for this study were as follows: theparticipant must have a primary diagnosis of SAD according
to the Diagnostic and Statistical Manual of Mental Disorders,
Fifth Edition (DSM-5); be aged ≥18 years; be fluent in Japanese;
have access to the internet via an appropriate device (eg,smartphone, tablet, and desktop or laptop computer); and beable to regularly visit their primary psychiatrist during the study.
The following exclusion criteria were used: the presence of
psychosis, bipolar disorder, or antisocial personality disorder;
active suicidal ideation with intent or plan; intellectual disability
or intellectual developmental disorder; current alcohol orsubstance dependence; and currently receiving any otherstructured psychological intervention or previously received
CBT for SAD.
The diagnostic assessment based on the DSM-5 criteria was
performed by an experienced psychiatrist at the study institution.
During the study eligibility assessment, the study therapist

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Intervention

iCT-SAD includes secure videoconferencing with recording
functionality to facilitate the attention and safety behavior
experiment and video feedback (more information on thesetechniques can be obtained in the study by Clark et al [26]), as
well as virtual audiences, where clients can practice giving
presentations. Clients were also encouraged to do several
behavioral experiments each week. Therapists support theirclients via telephone calls, asynchronous and SMS text
messaging, and occasional video calls via webcam. In total, 2
telephone calls were scheduled per week in the first 2 weeks oftreatment to support initial engagement, followed by a weekly
phone call until the end of the 14-week treatment phase. In thefollow-up phase, up to 3 booster phone calls were scheduled atmonthly intervals. Each call lasted approximately 20 minutes
and was used to review the client’s questionnaires, review
progress with treatment modules and behavioral experiments,
and plan for the coming week. Figure 1 provides an overview
of the treatment structure (further details can be obtained in the
study by Clark et al [24]).
To transport iCT-SAD to the Japanese context, the treatment
content was translated from English into Japanese, and several
minor adaptations were made to better suit the Japanese culturalcontext [32]. Adaptations were grouped into 4 categories(Linguistics and Metaphors, Social Systems, Social Behaviors,
and Familiarity). Linguistics and Metaphors encompassed
adaptations made because of differences in the way words,
idioms, and metaphors are used. Social Systems referred toadaptations made because of differences in legal, educational,
and health care systems. Social Behavior comprised adaptations
made because of differences in the way people think and behave
in social situations and what people expect of others in social
situations. Familiarity included adaptations made so that names,
songs, and products were more familiar to the Japanese people.
One example from Social Behavior is that a suggested
behavioral experiment in the original English version involved
having a conversation about blushing within earshot of someone
else on a bus or train to see how others respond. However, it isculturally inappropriate in Japan to talk loudly (or talk on thephone) on public transport, so adapting the experiment to takeplace while waiting for a bus or train is more suitable; the studyof Yoshinaga et al [32] provides more details and further
examples.

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Figure 1. Overview of the internet-delivered cognitive therapy for social anxiety disorder treatment procedure. GAD-7: Generalized Anxiety Disorder
Questionnaire 7-item; LSAS: Liebowitz Social Anxiety Scale; PHQ-9: Patient Health Questionnaire 9-item; SAQ: Social Attitudes Questionnaire; SBQ:
Social Behavior Questionnaire; SCQ: Social Cognitions Questionnaire; SPWSS: Social Phobia Weekly Summary Scale; TKSS: Taijin Kyofusho Scale;
WSAS: Work and Social Adjustment Scale.

Following translation and cultural adaptation, we embedded the
new content into a fully Japanese iCT-SAD web-based program,including audio and video materials.

Therapists, Training, and Supervision
The study therapists consisted of 7 Japanese mental healthprofessionals with experience in the use of individual
face-to-face CT for SAD (clinical psychologists: n=3, 43%;
registered nurses: n=3, 43%; and psychiatrist: n=1, 14%). Study
therapists were mainly male (n=5, 71%), with a mean age of
39.7 (SD 4.6) years and an average of 11.5 (SD 2.3) years of
postqualification clinical experience and 10.0 (SD 5.5) years ofexperience in providing CBT at the beginning of the study.
All study therapists received training in iCT-SAD, which was
led by the second author (GRT), who has extensive experience
in iCT-SAD. The study therapists initially attended a 2-day
workshop in Japan, covering site navigation and functionality,
structure and timing, module content, therapist communication,
the implementation of key techniques, and troubleshooting.
Each therapist was provided with test accounts to allow themto view the site from both client and therapist perspectives andto practice using the site during and after the workshop. To
reinforce learning from the workshop, study therapists also
referred to free therapist resources on CT for SAD and iCT-SAD[33]. These included workshop recordings, video illustrationsof key techniques, and other therapist support materials(including adaptations for remote delivery). As the start ofparticipant recruitment was delayed by the COVID-19 pandemic
and its related restrictions, there was a time gap between theworkshop and the implementation of iCT-SAD; thus, we
implemented an additional 90-minute web-based refresher
training before the enrollment of the first participant.
The first author (NY) provided weekly group supervision to thestudy therapists, which focused on reviewing clinical progress
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and planning sessions. NY also received individual supervision
for his cases and supervision of supervision from GRT weekly
to ensure that the implementation was consistent with the UK
and Hong Kong studies.

Outcomes
Preliminary Efficacy
The principal assessment points were baseline (week 0),
midtreatment (week 8), posttreatment (week 15; primaryassessment point), and follow-up (week 26). At these assessment
points, participants were asked to complete the set of outcome
measures listed in the following paragraphs. A subset of thesequestionnaires was also administered weekly during the main
treatment phase to track clinical progress and tailor theintervention to the client. All measures were completed using
the iCT-SAD program.
The primary outcome measure was the self-report version of
the Liebowitz Social Anxiety Scale (LSAS) [34,35], which isone of the most commonly used scales for assessing the severityof social anxiety. The LSAS is a 24-item measure that consistsof 2 subscales: fear and avoidance of performance and social
interactional situations. Each item is rated on a 4-point Likert
scale, ranging from 0 (no fear or never avoid) to 3 (severe fearor usually avoid).
The secondary outcomes included the following measures ofsocial anxiety processes, taijin kyofusho (the fear of offending
others), and general mood and functioning.
•

Social anxiety process measures: central processes in the
cognitive model of SAD were assessed using the Social
Cognitions Questionnaire (SCQ) [36], which has frequency
and belief subscales; Social Behavior Questionnaire (SBQ)[36]; Social Attitudes Questionnaire (SAQ) [36]; and Social
Phobia Weekly Summary Scale (SPWSS) [36]. We also
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assessed participation in social activities and satisfaction
with relationships using the Social Participation andSatisfaction scale [37].
Taijin kyofusho measure: taijin kyofusho has frequently
been discussed as a culture-specific expression of SAD
unique to East Asia, characterized by the fear of offending
others by one’s appearance or behavior [38]. It was assessedusing the Taijin Kyofusho Scale (TKSS) [39], which
consists of 31 items related to common concerns (eg, “I amafraid that when talking with others my trembling voice
will offend them” and “I am afraid that eye to eye contact
with other people will offend them”). Culturally sensitive
measures such as this may be particularly helpful inevaluating psychological interventions in different culturalcontexts.
General mood and functioning measures: we used thePatient Health Questionnaire 9-item (PHQ-9) [40,41] toassess the severity of depressive symptoms, the Generalized
Anxiety Disorder Questionnaire 7-item scale (GAD-7)[42,43] for generalized anxiety symptoms, and the Workand Social Adjustment Scale (WSAS) [44,45] for functional
impairment associated with a health problem.

We also monitored adherence to treatment, medication use, andthe incidence of adverse events. Adverse events, defined as any
unfavorable psychological, emotional, or behavioral occurrencein the study participants (regardless of whether they werecausally related to iCT-SAD), were monitored by the study
therapists and primary psychiatrists throughout the study. Of
these, we defined severe adverse events as those leading todeath, life-threatening events requiring some form of
high-intensity treatment (eg, hospital admission), or enduring
severe impairment or dysfunction. At midtreatment (week 8),
posttreatment (week 15), and follow-up assessment points (week26), the study therapists completed a web-based form on theoccurrence of any adverse events based on a verbal report fromeach participant and their primary psychiatrist.
To define response to treatment, remission from SAD, andreliable deterioration, we used the criteria described in theprevious studies of iCT-SAD [24,25,30,31], which were basedon the Jacobson and Truax methodology [46]. Response wasdefined as a pre- to posttreatment improvement on the LSAS
>31%, which is comparable with a Clinical Global Impression
improvement subscore of 2, a psychiatric measure often used
to define response [47]. Remission was defined as a drop in the
LSAS score of at least 12 points, combined with a posttreatment
score of ≤38. Reliable deterioration was defined as an increaseon the LSAS of at least 12 points and was examined frombaseline to posttreatment and from posttreatment to follow-up
assessment points.

Acceptability
The acceptability of iCT-SAD was measured based on the rateof participant dropout from the treatment, the level ofengagement with the program, and participants’ feedback about
their experience with iCT-SAD.
Dropout was defined as the premature cessation of treatment
before completing the planned number of therapy weeks
according to the protocol and not owing to participants’
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Yoshinaga et al
recovery. Previous studies of iCT-SAD observed low dropout
rates of <10% [24,25,30,31]. As this was a study in a new
cultural setting, we set the threshold that a dropout rate >20%
may suggest problems with treatment acceptability.
The level of engagement with the program was defined as therate of module completion (ie, the percentage of released
modules that were completed by participants). A previous UK
study using iCT-SAD [24] observed a module completion rateof 81%, indicating strong engagement. In this study, we defined
a completion rate of ≥70% as reflecting a good level ofengagement.
At the end of the follow-up phase, participants were invited tocomplete a web-based feedback survey about their experienceswith the treatment. This included questions about theirexperience with different modules, treatment components, andtherapist behavior, which were rated on a Likert scale from 0(not helpful at all) to 5 (extremely helpful). It also asked about
the amount of therapist contact, which was rated on a Likert
scale from 0 (too little contact) to 5 (too much contact), with ascore of 3 indicating Just the right amount. The participants
were also asked to provide overall comments and suggestions
for improvement. As an exploratory study in a new cultural
setting, we planned to review individual ratings and comments
rather than set specific mean thresholds to indicate acceptability.

Analysis
Participant demographics, clinical characteristics, activity on
the website, and categorical outcomes were analyzed
descriptively. Changes in continuous outcomes were analyzed
using linear mixed effects models, which have the advantageof accounting for nested data structures and data missing at
random. The models included time point (baseline,
midtreatment, posttreatment, and follow-up) as a categorical
fixed factor and participant as a random factor to account for
between-subject variation. All models used restricted maximum
likelihood estimation and an unstructured covariance matrix.
Q-Q plots indicated that the normality of residuals assumption
was met for all models. Effect sizes (Cohen d) were estimatedby dividing the adjusted difference by the baseline SD.
Participant feedback was analyzed descriptively.

Ethics Approval
All aspects of this study complied with the Declaration of
Helsinki, and the study protocol was reviewed and approvedby the Ethics Committee of the University of Miyazaki(reference O-0879). Written informed consent was obtained
from all the participants. Participant data confidentiality was
guaranteed, and all study data were deidentified.

Results
Participant Flow and Baseline Clinical Characteristics
A total of 16 potential participants were referred to the study,of which 1 (6%) participant was not eligible (major depressive
disorder was a primary diagnosis) and was referred elsewhere.
Of the remaining 15 participants who took part in the study andentered the treatment phase, 14 (93%) participants completed
the treatment phase (n=1, 7%, participant dropped out in week
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Yoshinaga et al6; for the analysis, week 6 questionnaire scores for thisparticipant were used as the midtreatment assessment point
where available), and 13 (93%) completed the subsequent
follow-up phase (n=1, 7%, participant declined to undertakethe follow-up phase but completed the follow-up assessment).
Baseline demographic and clinical characteristics of theparticipants are presented in Table 1. All participants met a
primary diagnosis of SAD according to the DSM-5, and almost
half (7/15, 47%) of the participants had a comorbid diagnosis,

primarily major depressive disorders (5/15, 33%). More thanhalf of the participants (9/15, 60%) were taking concurrent
antidepressant medication at baseline. Notably, 87% (13/15) ofparticipants had previously been treated with at least 1 courseofselective
serotonin
reuptakeinhibitororserotonin-noradrenaline reuptake inhibitor treatment without
substantial improvement in social anxiety; in other words, they
exhibited resistance to gold standard pharmacological treatment
for SAD at the beginning of the study [48].

Table 1. Baseline demographic and clinical characteristics (n=15).
VariableValue

Sex (female), n (%)

10 (67)Age (years), mean (SD)27.3 (6.6)

Marital status , n (%)
Single12 (80)Married3 (20)

Highest educational background , n (%)
Junior high school

1 (7)Senior high school

6 (40)≥3 years of college or university

8 (53)

Employment status , n (%)
Full-time work

4 (27)

Part-time work

1 (7)Student

5 (33)

Sick leave

3 (20)

Unemployed

2 (13)

Age of onset of SADa (years), mean (SD)

13.0 (4.1)

Duration of SAD (years), mean (SD)

14.3 (9.3)

Comorbidity (current), n (%)
Major depressive disorder

5 (33)

Panic disorder

1 (7)Autism spectrum disorder

1 (7)

None

8 (53)

Concurrent antidepressant medications (yes), n (%)
b

9 (60)

c

Number of previous courses of SSRI or SNRI treatments, n (%)

a0

2 (13)

1

7 (47)≥2

6 (40)

SAD: social anxiety disorder.

b

SSRI: selective serotonin reuptake inhibitor.

c

SNRI: serotonin-noradrenaline reuptake inhibitor.

Participant Use of iCT-SAD and Therapist Activity
Across the treatment phase, participants spent an average of
15.2 (SD 0.9) weeks, during which they logged into the programfor a mean of 43.7 (SD 13.3) hours.
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Therapists conducted a mean of 15.4 (SD 1.1) phone calls per
participant, with a mean duration of 27.7 (SD 5.7) minutes foreach call. They also made a mean of 1.3 (SD 0.5) video calls
per participant, with a mean duration of 90.1 (SD 22.5) minutes
for each call. Additionally, they sent an average of 48.8 (SDJMIR Form Res 2023 | vol. 7 | e45136 | p. 6
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17.4) asynchronous or SMS text messages to each participant.
The total amount of direct live communication with eachparticipant was therefore an average of 8.9 hours (equal to 538.6
minutes, SD 1.9 hours) during the treatment phase, with anadditional 1.2 hours (70.1 minutes, SD 0.3 hours) during thefollow-up phase. This is substantially less than the 18 to 21
hours required to deliver a course of face-to-face CT for SAD[15,26,27,29].

Outcomes
Preliminary Efficacy
The results for the continuous outcomes are presented in Table
2. Significant improvements were observed on the primary
outcome measure (LSAS; P<.001), indicating a reduction insocial anxiety symptoms. All secondary outcomes showedsignificant changes over the time period examined, indicating
reductions in symptoms of depression, generalized anxiety, andtaijin kyofusho; reductions in processes linked to themaintenance of social anxiety (negative social cognitions, safety
behaviors, and unhelpful social assumptions); increases in social
participation and satisfaction; and a reduction in the functional
impact of social anxiety. Effect size estimates (Cohen d) for the
LSAS were 3.66 at posttreatment and 4.05 at follow-up, which
are considered large. The pre- to posttreatment effect size
estimates for the secondary outcomes ranged between 0.68 and3.31.

Yoshinaga et alanxiety. None of the participants showed reliable deterioration
between the pre- and posttreatment assessments. Moreover, 7%(1/15) of participants showed reliable deterioration between
posttreatment and follow-up assessments. This participant had
declined to undergo the follow-up phase of the treatment.
Of the 9 participants taking antidepressant medications atbaseline, 2 (22%) showed a decrease in dosage at posttreatment;
6 (67%) remained at the same dosage; and 1 (11%) showed anincrease. In addition, 2 participants started taking antidepressantsduring the study. A sensitivity analysis excluding the 3participants who increased dosages or started antidepressantsduring the study showed a similar pre- to posttreatment effectsize (Cohen d=3.35) to the main analysis.
No severe adverse events were observed during the study.
Adverse events reported were either unrelated to the treatment(eg, feeling exhausted owing to increased demands at work andfeeling unwell owing to an adverse reaction to the COVID-19
vaccine) or reflected normal symptom fluctuation during
treatment (eg, increased anxiety symptoms before a challenging
behavioral experiment). The latter category included theparticipant who dropped out and the participant who declined
to undertake the follow-up phase. Both participants later
indicated that one of the reasons for this was finding theinteraction with their therapist anxiety provoking, especiallywhen planning and conducting challenging behavioral
experiments.

Of the 15 participants, 12 (80%) demonstrated response totreatment, and 9 (60%) demonstrated remission from social

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Table 2. Unadjusted means, SDs, adjusted differences, and effect sizes for the intent-to-treat sample (n=15).
Unadjusted mean (SD)

Adjusted difference (95% CI) P value

Within-group effect size, Cohen d (95% CI)a

Pretreatment

84.6 (14.2)

N/Ac

N/A

N/A

Midtreatment

59.1 (17.0)

25.5 (14.4 to 36.7)<.001

1.80 (1.01 to 2.59)

Posttreatment

31.7 (21.6)

51.9 (40.4 to 63.3)<.001

3.66 (2.85 to 4.46)

Follow-up

26.1 (24.0)

57.5 (46.1 to 68.9)<.001

4.05 (3.25 to 4.86)

Pretreatment

3.1 (0.7)

N/A

N/A

N/A

Midtreatment

2.2 (0.8)

0.9 (0.5 to 1.2)<.001

1.25 (0.74 to 1.76)

Posttreatment

1.5 (0.4)

1.5 (1.2 to 1.9)<.001

2.24 (1.72 to 2.77)

Follow-up

1.5 (0.5)

1.6 (1.2 to 1.9)<.001

2.31 (1.78 to 2.83)

Pretreatment

55.5 (18.2)

N/A

N/A

N/A

Midtreatment

29.8 (17.6)

25.7 (16.6 to 34.8)<.001

1.41 (0.91 to 1.91)

Posttreatment

13.2 (12.0)

41.6 (32.3 to 50.9)<.001

2.29 (1.77 to 2.80)

Follow-up

9.9 (12.2)

45.0 (35.7 to 54.3)<.001

2.47 (1.96 to 2.98)

Pretreatment

43.3 (8.5)

N/A

N/A

N/A

Midtreatment

33.3 (9.0)

9.9 (3.6 to 16.2).003

1.16 (0.43 to 1.90)

Posttreatment

24.4 (10.6)

18.8 (12.6 to 25.1)<.001

2.21 (1.48 to 2.95)

Follow-up

20.0 (10.7)

22.9 (16.5 to 29.3)<.001

2.69 (1.94 to 3.44)

Pretreatment

208.7 (24.2)

N/A

N/A

N/A

Midtreatment

160.2 (35.2)

48.6 (29.2 to 67.9)<.001

2.01 (1.21 to 2.80)

Posttreatment

128.6 (46.9)

80.2 (60.9 to 99.5)<.001

3.31 (2.52 to 4.11)

Follow-up

122.4 (44.5)

86.4 (67.1 to 105.7)<.001

3.57 (2.77 to 4.37)

Pretreatment

25.8 (7.9)

N/A

N/A

N/A

Midtreatment

21.2 (7.3)

4.6 (0.1 to 9.1)

.04

0.58 (0.02 to 1.15)

Posttreatment

12.4 (7.2)

12.7 (8.1 to 17.2)<.001

1.61 (1.03 to 2.19)

Follow-up

12.3 (9.7)

12.7 (8.2 to 17.3)<.001

1.62 (1.04 to 2.20)

Pretreatment

34.2 (12.0)

N/A

N/A

N/A

Midtreatment

51.8 (16.0)−17.7 (−23.9 to −11.5)<.001

1.48 (0.96 to 2.00)

Posttreatment

56.4 (11.8)−22.3 (−28.5 to −16.1)<.001

1.87 (1.35 to 2.39)

Follow-up

52.9 (18.7)−18.8 (−25.0 to −12.5)<.001

1.57 (1.05 to 2.09)

Pretreatment

14.9 (8.0)

N/A

N/A

N/A

Midtreatment

20.5 (9.2)−5.5 (−8.1 to −2.9)<.0010.69 (0.36 to 1.02)

Posttreatment

22.9 (7.8)−7.9 (−10.6 to −5.3)<.001

0.99 (0.66 to 1.32)

Follow-up

24.1 (8.6)−9.2 (−11.8 to −6.5)<.001

1.14 (0.82 to 1.47)

Measure and time point
LSASb

d

SCQ frequency

SCQ belief

SBQe

SAQf

SPWSS

g

Social participation

Social satisfaction

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Yoshinaga et al

Unadjusted mean (SD)

Adjusted difference (95% CI) P value

Within-group effect size, Cohen d (95% CI)a

Pretreatment

136.8 (33.6)

N/A

N/A

N/A

Midtreatment

109.2 (35.5)

27.0 (9.9 to 44.0).003

0.80 (0.30 to 1.31)

Posttreatment

75.1 (25.0)

61.0 (44.0 to 78.1)<.001

1.82 (1.31 to 2.33)

Follow-up

75.6 (32.9)

60.6 (43.6 to 77.7)<.001

1.80 (1.30 to 2.31)

Pretreatment

12.3 (5.6)

N/A

N/A

N/A

Midtreatment

9.2 (5.4)

3.1 (0.9 to 5.2)

.007

0.55 (0.16 to 0.94)

Posttreatment

6.0 (5.6)

6.0 (3.7 to 8.0)<.001

1.07 (0.67 to 1.47)

Follow-up

5.9 (6.2)

6.1 (3.9 to 8.3)<.001

1.09 (0.69 to 1.49)

Pretreatment

9.3 (5.3)

N/A

N/A

N/A

Midtreatment

6.7 (3.5)

2.6 (0.6 to 4.6)

.01

0.49 (0.11 to 0.86)

Posttreatment

3.1 (2.5)

6.9 (4.0 to 8.1)<.001

1.14 (0.76 to 1.52)

Follow-up

3.0 (2.7)

6.2 (4.2 to 8.3)<.001

1.17 (0.79 to 1.55)

Pretreatment

13.5 (8.5)

N/A

N/A

N/A

Midtreatment

11.8 (9.7)

1.7 (−2.1 to 5.4)

.37

0.20 (−0.24 to 0.64)

Posttreatment

7.3 (8.3)

5.8 (1.9 to 9.6).004

0.68 (0.23 to 1.13)

Follow-up

6.8 (9.3)

6.3 (2.4 to 10.1).002

0.74 (0.28 to 1.19)

Measure and time point
TKSSh

i

PHQ-9

GAD-7

j

WSASk

a

Within-group effect sizes represent change from baseline using the adjusted difference scores at each time point.

b

LSAS: Liebowitz Social Anxiety Scale.

c

N/A: not applicable.

d

SCQ: Social Cognitions Questionnaire (mean scores).

e

SBQ: Social Behavior Questionnaire.

f

SAQ: Social Attitudes Questionnaire.

g

SPWSS: Social Phobia Weekly Summary Scale.

h

TKSS: Taijin Kyofusho Scale.

i

PHQ-9: Patient Health Questionnaire 9-item.

j

GAD-7: Generalized Anxiety Disorder Questionnaire 7-item.

k

WSAS: Work and Social Adjustment Scale.

Acceptability
As described earlier, 7% (1/15) of participants dropped out
during the treatment phase. This reflected a good overall levelof treatment acceptability. The core modules were released to,and completed by, all the participants. On average, 13.0 (SD3.6) additional modules were released and 11.8 (SD 3.8) optional
modules were completed. On average, participants completed
94% of the modules released to them, indicating a strong levelof engagement with the program. They also completed anaverage of 17.6 (SD 7.8) behavioral experiments.
A total of 87% (13/15) of participants, all of whom completed
the treatment and follow-up phases, responded to the feedback
survey. The participant who dropped out and the participant
who declined the follow-up phase did not respond to invitations
to submit feedback. As presented in Table 3, respondents’ meanhttps://formative.jmir.org/2023/1/e45136

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ratings on a Likert scale from 0 (not helpful at all) to 5
(extremely helpful) indicated that the core modules of Safety
behaviors, Behavioral experiments, and Feeling self-conscious
were perceived as the most helpful. The treatment components
rated as the most helpful were phone calls, written example
vignettes, and behavioral experiment logs. The virtual audiencefeature received the lowest mean rating, although it had greater
variability, and all other treatment components received ratings>3.62. The most helpful therapist behaviors were making
suggestions for behavioral experiments, explaining things in
the program, and providing reminders (eg, about working on
the site, experiments, or completing questionnaires).
Respondents’ comments also highlighted the helpfulness of thetherapist having an affirming attitude, focusing on the client’s
strengths, flexibility in approach, and openness to questions.
Respondents also rated the amount of contact from their therapist
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JMIR FORMATIVE RESEARCH
on a Likert scale, ranging from 0 (too little contact) to 5 (toomuch contact), with a score of 3 indicating Just the right amount.
The mean rating was 3.23 (SD 0.44).
Respondents’ suggestions for improvement included fixing
technical issues such as delays in receiving 2-factor

Yoshinaga et alauthentication codes to access the site and including more video
illustrations or testimony involving Japanese clients. Some
respondents also noted difficulty in finding time to work on thetreatment site regularly because of their busy schedules.

Table 3. Mean ratings on a Likert scale for participant experience with the therapy (n=13)a.
Item

Values, mean (SD)Core modulesb
Introducing the treatment

4.46 (0.66)

Getting started

4.38 (0.77)

Feeling self-conscious

4.69 (0.48)

Safety behaviors

4.85 (0.38)

My attention and safety behavior experiment4.54 (0.66)

Watching your conversation videos

4.46 (0.78)

Getting Out of your head and into the world

4.38 (0.77)

Behavioral experiments

4.77 (0.60)

Treatment componentsbVideo examples

4.00 (0.71)

Written vignettes examples

4.46 (0.66)

Testimonies from previous clients

3.85 (0.69)

Street surveys

3.85 (1.07)

Attention training exercises (video and audio)

4.00 (0.82)

Behavioral experiment log

4.31 (0.63)

Webcam

3.69 (0.95)

Library

3.77 (1.24)

My model3.62 (0.65)

Virtual audiences

2.62 (1.66)

Messaging function (e-mails) within website

3.92 (1.12)

SMS text messages

3.92 (1.04)

Phone calls

4.69 (0.63)

Webcam chats

4.23 (0.83)

Therapist behaviorsb
Suggestions for new behavioral experiments

4.62 (0.65)

General encouragement

4.54 (0.78)

Clarification for completed modules

4.31 (0.85)

Clarification for completed experiments

4.38 (0.77)

Helping me reexamine my beliefs

4.23 (1.01)

Explaining things in the internet program

4.54 (0.78)

Reminders (eg, to log on, to complete questionnaires, and to complete behavioral experiments)

4.54 (0.66)

The amount of therapist contactc

3.23 (0.71)a

A total of 2 of the 15 participants who dropped out of treatment or declined to undergo the follow-up phase did not respond to invitations to submit
feedback.
b

Rated on a Likert scale from 0 (not helpful at all) to 5 (extremely helpful).

c

Rated on a Likert scale from 0 (too little contact) to 5 (too much contact), with a score of 3 indicating Just the right amount.

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Benchmarking Against UK and Hong Kong Efficacy
Table 4 presents a comparison of the results of this study withthose of previous UK and Hong Kong studies [24,25,30,31].

Participants in Japan showed at least as much improvement as
those in the United Kingdom and Hong Kong. The larger effectsize relative to other studies may have resulted from the higher
baseline severity and lower baseline SD in this sample.

Table 4. Comparison of results with UK and Hong Kong studies using internet-delivered cognitive therapy for social anxiety disorder (iCT-SAD).
Stott et al [25], 2013

Clark et al [24], 2022

Study type

Single-arm trial

RCTa (iCT-SAD arm) Single-arm trial

RCT (iCT-SAD arm)Single-arm trial

Location

United Kingdom

United Kingdom

Hong Kong

Hong Kong

Japan

Participants, N

11

49

6

22

15

LSASb at baseline, mean (SD)80.0 (24.6)

77.7 (17.7)

75.8 (30.4)

76.1 (19.7)

84.6 (14.2)

LSAS at posttreatment, mean(SD)

39.8 (30.1)

32.2 (19.6)

22.0 (21.0)

21.1 (21.0)

31.7 (21.6)

2.57

1.77

2.79

3.73

Effect size (pre- to posttreatment 1.63
Cohen d)a

Thew et al [31], 2019 Thew et al [30], 2022 This studycResponse rate (%)d

81.8

85.4

83.3

95.5

80

Remission rate (%)d

63.6

75

83.3

86.4

60

RCT: randomized controlled trial.

b

LSAS: Liebowitz Social Anxiety Scale.

c

For comparability, all effect sizes shown are within-group and are calculated using raw unadjusted mean LSAS scores and the baseline SD, as thesevalues are available in all papers.
d

The criteria to define response and remission were the same across studies and relate to the posttreatment assessment.

Discussion
Principal Findings and Comparison With Prior Work
This study aimed to examine the preliminary efficacy andacceptability of culturally adapted Japanese iCT-SAD in
Japanese clinical settings and to understand whether the UK
and Hong Kong findings [24,25,30,31] could be replicated whentranslated and culturally adapted iCT-SAD was used in theJapanese context. The results yielded 2 key findings. First, thetreatment led to significant improvements on all outcome
measures, and these improvements were maintained during thefollow-up phase. Although controlled studies are needed formore robust comparisons, the within-group LSAS effect sizein this pilot trial was comparable with those obtained in studiesof the English-language program in the United Kingdom andHong Kong [24,25,30,31]. Furthermore, in line with the previous
UK and Hong Kong studies, Japanese iCT-SAD required lesstherapist contact time per client (8.97 hours) compared with
face-to-face CT (18-21 hours), representing a time saving of
50% to 58% compared with an equivalent treatment. This
provides an initial indication that previous findings can be
successfully replicated when translated and culturally adapted
iCT-SAD is used in a different cultural setting. Second, theacceptability of the intervention was demonstrated by mostparticipants completing the treatment, showing a strong levelof engagement in the program, and providing positive feedback.
The baseline clinical characteristics of our participants wereslightly different from those observed in the previous UK andHong Kong studies. This sample had a relatively higher severityof social anxiety and depressive symptoms at baseline. However,https://formative.jmir.org/2023/1/e45136

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this severity was similar to that observed in previous studies of
SAD in Japan [15,49]. In addition, many participants in thisstudy were taking antidepressants at baseline and had previously
been treated with at least 1 selective serotonin reuptake inhibitoror serotonin-noradrenaline reuptake inhibitor. This is commonly
seen among Japanese clinical samples seeking psychologicaltreatment because pharmacotherapy has historically been morecommon in Japan [21,49-52]. Therefore, this sample appears
to be representative of clinical SAD samples in Japan.
The findings of this study are consistent with those of otherstudies of culturally adapted CBT internet interventions, whichhave typically found that these interventions have been well
accepted by participants with positive outcomes for problems
including SAD [53-56], depression [57-59], and insomnia[60,61]. However, it has been highlighted that the exact detailsof the cultural adaptations made are not always provided andcould be made more explicit in future studies [32].
A total of 33% (5/15) of the participants had a comorbid major
depressive disorder at baseline; 4 (80%) of these 5 participants
successfully worked on and completed iCT-SAD, showing
improvements in both SAD and depression. This is consistent
with previous studies on CT-SAD and iCT-SAD, which haveindicated that when depression symptoms are secondary to SAD,
the provision of SAD-focused treatment tends to also relieve
depression [15,24,26-30]. The iCT-SAD program contains an
optional Managing my mood module, which can be provided
to clients who require further support around this or in situations
where low mood may be reducing motivation to work on otheraspects of treatment. The program also administers the PHQ-9
weekly, which allows the therapist to monitor symptoms ofdepressed mood and clinical risk, and if warranted based on
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JMIR FORMATIVE RESEARCH
their clinical judgment, to take immediate steps to supportclients’ safety. Clinicians who are assessing comorbid SAD anddepression are encouraged to inquire about the chronology ofthese 2 problems, current risk, and the client’s goals for therapy
when making treatment-related decisions.
As client adherence is a key determinant of the effectiveness ofinternet treatment for anxiety and depressive disorders [62], wemust caution that 1 participant dropped out of treatment and 1
participant declined to undertake the follow-up phase because
they found the interaction with their therapist anxiety provoking.
It is notable that this is not something that they were able toexpress directly to their therapist and reflects a broader challenge
in treating SAD as clients may view the therapist as a phobic
object [63] and therefore use safety behaviors such as avoiding
sharing their opinions. It is possible this may be particularlycommon in Japanese or other East Asian contexts because
Japanese clients tend to view the therapist as an authority figureand deify the therapist [64]. Early modules in iCT-SAD aim toelicit potential concerns from clients about treatment in generaland treatment in a web-based format, which can facilitate
discussions with the therapist and address potential barriers toengagement. However, the results of this study highlight theneed for therapists to keep this in mind throughout treatment
and to take opportunities to ask directly about treatment-related
concerns.

Limitations
The main limitations of this study include (1) the small numberof participants, (2) no control group for comparison, (3) threeparticipants having started or increased antidepressants during

Yoshinaga et al
the study, and (4) participant feedback not being based on thewhole study sample. Furthermore, (5) iCT-SAD was provided
in combination with usual care, which means that the specificeffects of iCT-SAD alone cannot be fully evaluated using thisstudy design. The participants were already receiving usual careon a regular basis from their psychiatrist at the time ofrecruitment. Although this means that the improvements
observed cannot be due to the effects of initiating work with a
psychiatrist, it could perhaps be that other aspects of continued
psychiatrist contact, or the combination with iCT-SAD,
contributed to the improvements observed in this study.
Notwithstanding these limitations, this study yielded promisingfindings that warrant further investigation in a larger randomized
controlled trial.

Conclusions
This pilot trial suggests that translated and culturally adapted
iCT-SAD shows promising initial efficacy and acceptability inthe treatment of SAD with Japanese clients. This is evidenced
by the excellent clinical outcomes obtained in treatment using
the Japanese iCT-SAD modules, the low dropout rate from thetreatment, a strong level of participant engagement in the
program, and the positive feedback provided by participants,
all of which are comparable with what was observed in the
English-language program in the UK and Hong Kong studies.
iCT-SAD shows promise as a way of providing evidence-based
psychological therapies for a wide range of people experiencing
social anxiety in Japan. Future studies should build on thesepreliminary findings by conducting a randomized controlled
trial with larger samples.

Acknowledgments
The authors wish to thank the study participants. The authors also thank Dr Hiromitsu Fukunaga, Dr Kentaro Mizuno, Dr Junya
Okazaki, Dr Eiji Shimizu, Dr Arisa Tsurue, Dr Michiyo Iwakiri, and Professor Yasushi Ishida for supporting participant recruitment;
Dr Taichiro Kishimoto for providing and updating information regarding government regulations and guidelines for telemedicine
and telepsychiatry in Japan; and Dr Osamu Kobori for helping with the translation and cultural adaptation process of the treatment
contents. This work was supported by Grants-in-Aid for Scientific Research from the Japan Society for the Promotion of Science(18K13350 and 20H01769 to NY), Research Grant from the Public Health Research Foundation (to NY), Research Grant fromthe Telecommunications Advancement Foundation (to NY), Grant from The Daiwa Anglo-Japanese Foundation (13068 and
13890 to GRT), Wellcome Trust (069777 and 200796 to DMC), and the Oxford Health National Institute for Health and Care
Research Biomedical Research Centre (to GRT and DMC). The views expressed are those of the authors and not necessarily
those of the Japan Society for the Promotion of Science, the National Health Service, the National Institute for Health and Care
Research, the Department of Health, or other organizations.

Data Availability
Anonymized data from this paper are available for research purposes on request to the corresponding author. Broader public data
sharing for this study has been restricted by the Ethics Committee at the University of Miyazaki because the consent obtained
from the participants does not cover the unlimited public sharing of the data.

Authors' Contributions
NY, GRT, and DMC conceptualized and designed this study. NY, YH, JM, HT, RT, MA, and YK performed the screening andprovided therapy. NY and GRT supervised the study therapists. YH managed and monitored the progress of the study. AS andSHLG provided technical support for developing and managing the program websites. GRT contributed to data analysis. NY andGRT drafted the first manuscript. All authors critically revised the first version of the manuscript for important intellectual content
and approved the final version.

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Conflicts of Interest
None declared.

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Yoshinaga et al

Abbreviations
CBT: cognitive behavioral therapy
CT: cognitive therapy
DSM-5: Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition
GAD-7: Generalized Anxiety Disorder Questionnaire 7-item
iCT-SAD: internet-delivered cognitive therapy for social anxiety disorder
LSAS: Liebowitz Social Anxiety Scale
PHQ-9: Patient Health Questionnaire 9-item
SAD: social anxiety disorder
SAQ: Social Attitudes Questionnaire
SBQ: Social Behavior Questionnaire
SCQ: Social Cognitions Questionnaire
SPWSS: Social Phobia Weekly Summary Scale
TKSS: Taijin Kyofusho Scale
WSAS: Work and Social Adjustment Scale

Edited by T Leung; submitted 17.12.22; peer-reviewed by A Nakagawa, S Schueller; comments to author 20.01.23; revised version
received 15.02.23; accepted 31.03.23; published 05.05.23
Please cite as:
Yoshinaga N, Thew GR, Hayashi Y, Matsuoka J, Tanoue H, Takanashi R, Araki M, Kanai Y, Smith A, Grant SHL, Clark DM
Preliminary Evaluation of Translated and Culturally Adapted Internet-Delivered Cognitive Therapy for Social Anxiety Disorder:
Multicenter, Single-Arm Trial in JapanJMIR Form Res 2023;7:e45136
URL: https://formative.jmir.org/2023/1/e45136
doi: 10.2196/45136
PMID: 37145850©Naoki Yoshinaga, Graham R Thew, Yuta Hayashi, Jun Matsuoka, Hiroki Tanoue, Rieko Takanashi, Mutsumi Araki, Yoshihiro
Kanai, Alisha Smith, Sophie H L Grant, David M Clark. Originally published in JMIR Formative Research(https://formative.jmir.org), 05.05.2023. This is an open-access article distributed under the terms of the Creative Commons
Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction
in any medium, provided the original work, first published in JMIR Formative Research, is properly cited. The complete
bibliographic information, a link to the original publication on https://formative.jmir.org, as well as this copyright and license
information must be included.

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