UMIN-ICDS Clinical Trial

Public title

A randomised controlled trial of internet-delivered cognitive therapy for social anxiety disorder (iCT-SAD) in Japan

Acronym

A randomised controlled trial of internet-delivered cognitive therapy for social anxiety disorder (iCT-SAD) in Japan

Scientific Title

An evaluation of the efficacy of internet-delivered cognitive therapy for social anxiety disorder (iCT-SAD) in Japan: a randomised controlled trial

Scientific Title:Acronym

An evaluation of the efficacy of internet-delivered cognitive therapy for social anxiety disorder (iCT-SAD) in Japan: a randomised controlled trial

Region

Japan

Condition

Social anxiety disorder

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To evaluate whether Japanese iCT-SAD in combination with treatment as usual (iCT-SAD + TAU) is superior to TAU alone in clients with social anxiety disorder

Basic objectives2

Others

Basic objectives -Others

The secondary objectives are as follows:
- To examine whether the Japanese iCT-SAD programme is acceptable to clients
- To evaluate how the outcomes of the iCT-SAD + TAU intervention compare to previous studies of the iCT-SAD programme in the UK and Hong Kong
- An exploratory examination of whether baseline clinical and demographic characteristics are associated with clinical outcomes in the iCT-SAD + TAU arm
- An exploratory examination of candidate mediators of the relationship between treatment arm and clinical outcome

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase III

Primary outcomes

Liebowitz Social Anxiety Scale (LSAS) (self-report) [Pre (week 0), Mid (week 8), Post (week 15), 3-mo FU (week 27, Intervention arm only)]

Key secondary outcomes

[efficacy measures]
- Proportion of participants who met the SAD diagnostic criteria evaluated using the Anxiety and Related Disorders Interview Schedule for DSM-5 (ADIS-5) [Pre (week 0), Post (week 15), 3-mo FU (week 27, Intervention arm only)]
- Social Cognitions Questionnaire (SCQ) [Pre (week 0), Mid (week 8), Post (week 15), 3-mo FU (week 27, Intervention arm only)]
- Social Behavioural Questionnaire (SBQ) [Pre (week 0), Mid (week 8), Post (week 15), 3-mo FU (week 27, Intervention arm only)]
- Social Attitudes Questionnaire (SAQ) [Pre (week 0), Mid (week 8), Post (week 15), 3-mo FU (week 27, Intervention arm only)]
- Social Phobia Weekly Summary Scale (SPWSS) [Pre (week 0), Mid (week 8), Post (week 15), 3-mo FU (week 27, Intervention arm only)]
- Social Participation and Satisfaction Scale (SPSS) [Pre (week 0), Mid (week 8), Post (week 15), 3-mo FU (week 27, Intervention arm only)]
- Patient Health Questionnaire-9 (PHQ-9) [Pre (week 0), Mid (week 8), Post (week 15), 3-mo FU (week 27, Intervention arm only)]
- Generalized Anxiety Disorder-7 (GAD-7) [Pre (week 0), Mid (week 8), Post (week 15), 3-mo FU (week 27, Intervention arm only)]
- Work and Social Adjustment Scale (WSAS) [Pre (week 0), Mid (week 8), Post (week 15), 3-mo FU (week 27, Intervention arm only)]

[response to treatment]
- Response: Improvement in the LSAS between pre- and post-treatment greater than 31%
- Remission: Decrease in the LSAS score of at least 12 points and post-treatment score of 38 points or less
- Reliable deterioration: Increase of at least 12 points in the LSAS score

[acceptability measures]
- Dropout rate
- Rates of module completion (Intervention arm only)
- Participants' feedback about their experience with iCT-SAD (Intervention arm only)

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Central registration

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Behavior,custom

Interventions/Control_1

Intervention: iCT-SAD + TAU, therapist-guided modular online cognitive therapy for social anxiety based on the Clark and Wells (1995) cognitive model in addition to treatment as usual (14 weeks + 3-month booster phase, N=30)

Interventions/Control_2

Control: Treatment as usual (TAU) alone, provided by a primary psychiatrist including medication monitoring and supportive counselling, with at least monthly visit (14 weeks, N=30)

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

18

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

- Primary diagnosis of SAD based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)
- Aged 18 years or over
- Regular, private access to an appropriate internet enable device
- Resident in Japan and proficient in Japanese (written and spoken)
- Able to visit their primary psychiatrist regularly during the study (at least monthly in person) for safety monitoring
- Participant not currently undertaking other structured psychological therapy and agrees not to start such interventions during the study

Key exclusion criteria

- Current psychosis, bipolar disorder, or antisocial personality disorder
- Current alcohol/substance use disorder (moderate or severe)
- Active suicidal ideation with intent or plan
- Previously received CT or cognitive behavioural therapy for SAD (defined as at least 5 sessions and including an exposure component)

Target sample size

60

Name of lead principal investigator

1st name	Naoki
Middle name
Last name	Yoshinaga

Organization

University of Miyazaki

Division name

School of Nursing, Faculty of Medicine

Zip code

889-1692

Address

5200 Kihara, Kiyotake, Miyazaki, 889-1692, Japan.

TEL

0985-85-9784(+81-985-85-9784)

Email

naoki-y@med.miyazaki-u.ac.jp

Name of contact person

1st name	Naoki
Middle name
Last name	Yoshinaga

Organization

University of Miyazaki

Division name

School of Nursing, Faculty of Medicine

Zip code

889-1692

Address

5200 Kihara, Kiyotake, Miyazaki, Japan.

TEL

0985-85-9784(+81-985-85-9784)

Homepage URL

https://naoki-y.wixsite.com/ictsad

Email

naoki-y@med.miyazaki-u.ac.jp

Institute

University of Miyazaki

Institute

Department

Personal name

Organization

MEXT(Japan)

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Daiwa Anglo-Japanese Foundation, Wellcome Trust, Oxford Health NIHR Biomedical Research Centre

Organization

The Ethics Committee of the University of Miyazaki

Address

5200 Kihara, Kiyotake, Miyazaki, Japan.

Tel

0985-85-9403(+81-985-85-9403)

Email

rinken@med.miyazaki-u.ac.jp

Secondary IDs

YES

Study ID_1

ISRCTN82859645

Org. issuing International ID_1

ISRCTN Registry

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2023

Year

11

Month

20

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Open public recruiting

Date of protocol fixation

2023

Year

10

Month

18

Day

Date of IRB

2023

Year

11

Month

01

Day

Anticipated trial start date

2023

Year

12

Month

01

Day

Last follow-up date

2025

Year

12

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2023

Year

11

Month

06

Day

Last modified on

2024

Year

01

Month

29

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060093