UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000043720
Receipt No. R000049916
Scientific Title The effect of four-session program of mindfulness and cognitive behavioral therapy for social anxiety disorder
Date of disclosure of the study information 2021/03/23
Last modified on 2021/09/16

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title The effect of four-session program of mindfulness and cognitive behavioral therapy for social anxiety disorder
Acronym The four-session program of mindfulness and cognitive behavioral therapy for social anxiety disorder
Scientific Title The effect of four-session program of mindfulness and cognitive behavioral therapy for social anxiety disorder
Scientific Title:Acronym The four-session program of mindfulness and cognitive behavioral therapy for social anxiety disorder
Region
Japan

Condition
Condition Social anxiety disorder
Classification by specialty
Not applicable
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine a eight-session program of mindfulness and cognitive behavioral therapy for social anxiety disorder.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Japanese Version of Liebowitz Social Anxiety Scale
Key secondary outcomes Japanese Version of Self-rating Depression Scale
Japanese Version of Five Facet Mindfulness Questionnaire
Speech Cost/Probability bias Scale
Japanese Version of Short Fear of Negative Evaluation Scale
Japanese Version of Self-Focused Attention Scale
Japanese Version of Emotion Regulation Questionnaire

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 Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 Fight-session program of mindfulness and cognitive behavioral therapy
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 To obtain the written consent of individual
Key exclusion criteria Those who meet the diagnostic criteria of M.I.N.I. in schizophrenia or bipolar disorder
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Shota
Middle name
Last name Noda
Organization Musashino University
Division name Graduate School of Human and Social Sciences
Zip code 135-8181
Address 3-3-3 Ariake, Koutouku, Tokyo, Japan
TEL 0355307624
Email norashouta@outlook.jp

Public contact
Name of contact person
1st name Shota
Middle name
Last name Noda
Organization Musashino University
Division name Graduate School of Human and Social Sciences
Zip code 135-8181
Address 3-3-3 Ariake, Koutouku, Tokyo, Japan
TEL 0355307624
Homepage URL
Email norashouta@outlook.jp

Sponsor
Institute Musashino University
Institute
Department

Funding Source
Organization Japan society for the promotion of science
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Musashino university
Address 3-3-3 Ariake, Koutouku, Tokyo, Japan
Tel not open to the public
Email not open to the public

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

Other administrative information
Date of disclosure of the study information
2021 Year 03 Month 23 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
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

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2020 Year 09 Month 14 Day
Date of IRB
2020 Year 09 Month 14 Day
Anticipated trial start date
2020 Year 11 Month 01 Day
Last follow-up date
2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2021 Year 03 Month 23 Day
Last modified on
2021 Year 09 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049916

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.