UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044810 |
|---|---|
| Receipt number | R000051175 |
| Scientific Title | An evaluation of the feasibility, acceptability, and preliminary efficacy of internet-delivered cognitive therapy for social anxiety disorder in Japan: A single-group pilot trial |
| Date of disclosure of the study information | 2021/07/10 |
| Last modified on | 2023/06/16 17:37:28 |
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Basic information
Public title
A pilot study of internet cognitive therapy for social anxiety disorder in Japan
Acronym
A pilot study of internet cognitive therapy for social anxiety disorder in Japan
Scientific Title
An evaluation of the feasibility, acceptability, and preliminary efficacy of internet-delivered cognitive therapy for social anxiety disorder in Japan: A single-group pilot trial
Scientific Title:Acronym
A pilot study of internet cognitive therapy for social anxiety disorder in Japan
Region
| Japan |
Condition
Condition
Social anxiety disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the feasibility, acceptability, and preliminary efficacy of internet-delivered cognitive therapy for Japanese individuals with social anxiety disorder
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Liebowitz Social Anxiety Scale (LSAS) (self-report) [Pre, Mid, Post, 3-mo Follow-up]
Key secondary outcomes
Taijin Kyofusho Scale (TKS Scale) [Pre, Mid, Post, 3-mo Follow-up]
Patient Health Questionnaire-9 (PHQ-9) [Pre, Mid, Post, 3-mo Follow-up]
Generalized Anxiety Disorder-7 (GAD-7) [Pre, Mid, Post, 3-mo Follow-up]
Social Participation and Satisfaction Scale (SPSS) [Pre, Mid, Post, 3-mo Follow-up]
Work and Social Adjustment Scale (WSAS) [Pre, Mid, Post, 3-mo Follow-up]
Adverse event [Pre, Mid, Post, 3-mo Follow-up]
Weekly process assessment: LSAS, PHQ-9, GAD-7, WSAS, Social Phobia Weekly Summary Scale (SPWSS), Social Cognitions Questionnaire (SCQ)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Therapist-supported internet-delivered cognitive therapy (14-16 weeks, N=12-16)
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Diagnosis of social anxiety disorder based on DSM-5
Informed consent given
Aged 18 years or over
Able to access the internet and use an appropriate device
Regularly meet their primary psychiatrist to monitor safety and risk
Key exclusion criteria
Currently receiving any other psychological intervention
Previously received cognitive/behavioural therapy for social anxiety disorder
Intellectual disability or intellectual developmental disorder
Current alcohol or substance dependence
Presence or suspected presence of psychosis, bipolar disorder or serious personality disorder
Suicidal intent or recurrent self-harming behavior
Neurologic or neuropsychiatric disorder that adversely affects the cognitive performance
Target sample size
16
Research contact person
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-city, Miyazaki
TEL
0985-85-9784
naoki-y@med.miyazaki-u.ac.jp
Public contact
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-city, Miyazaki
TEL
0985-85-9784
Homepage URL
naoki-y@med.miyazaki-u.ac.jp
Sponsor or person
Institute
University of Miyazaki
Institute
Department
Personal name
Funding Source
Organization
MEXT(Japan)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Fukunaga Internal and Neuropsychiatry Clinic (Miyazaki), Wakakusa Hospital (Miyazaki), International University of Health and Welfare Narita Hospital (Chiba), Higashi Omiya Mental Clinic (Saitama), Kokoro no Clinica OASIS (Miyagi), Chiba University Hospital (Chiba), Akasaka Clinic for Psychiatry and Psychosomatic Medicine (Warakukai Medical Corp) (Tokyo), Gokiso Kokoro no Clinic (Aichi), Gokiso Counseling Office (Aichi)
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee, University of Miyazaki
Address
Kihara 5200, Kiyotake, Miyazaki-city, Miyazaki, Japan
Tel
0985-85-9010
igakubu_kenkyu@med.miyazaki-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
福永内科神経科医院（宮崎）、若草病院（宮崎）、国際医療福祉大学成田病院（千葉）、東大宮メンタルクリニック（埼玉）、こころのクリニックOASIS（宮城）、千葉大学医学部附属病院（千葉）、医療法人和楽会心療内科・神経科赤坂クリニック（東京）、御器所こころのクリニック（愛知）、ごきそカウンセリングオフィス（愛知）
Fukunaga Internal and Neuropsychiatry Clinic (Miyazaki), Wakakusa Hospital (Miyazaki), International University of Health and Welfare Narita Hospital (Chiba), Higashi Omiya Mental Clinic (Saitama), Kokoro no Clinica OASIS (Miyagi), Chiba University Hospital (Chiba), Akasaka Clinic for Psychiatry and Psychosomatic Medicine (Warakukai Medical Corp) (Tokyo), Gokiso Kokoro no Clinic (Aichi), Gokiso Counseling Office (Aichi)
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 07 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://formative.jmir.org/2023/1/e45136
Number of participants that the trial has enrolled
15
Results
iCT-SAD led to significant improvements in social anxiety symptoms during the treatment phase, 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% of participants demonstrated reliable improvement, and 60% of participants demonstrated remission from social anxiety. No serious adverse events occurred.
Results date posted
| 2022 | Year | 12 | Month | 20 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
No serious adverse events occurred.
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 01 | Month | 14 | Day |
Date of IRB
| 2021 | Year | 02 | Month | 01 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 10 | Day |
Last follow-up date
| 2022 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
| 2022 | Year | 11 | Month | 30 | Day |
Date trial data considered complete
| 2022 | Year | 11 | Month | 30 | Day |
Date analysis concluded
| 2022 | Year | 12 | Month | 15 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 07 | Month | 09 | Day |
Last modified on
| 2023 | Year | 06 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051175
