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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000036763
Receipt No. R000041893
Scientific Title The effect of four times programs of mindfulness and cognitive behavioral therapy for social anxiety: a pilot randomized study of individuals with high social anxiety.
Date of disclosure of the study information 2019/05/16
Last modified on 2019/05/16

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Basic information
Public title The effect of four times programs of mindfulness and cognitive behavioral therapy for social anxiety
Acronym Four times programs of mindfulness and cognitive behavioral therapy for social anxiety
Scientific Title The effect of four times programs of mindfulness and cognitive behavioral therapy for social anxiety: a pilot randomized study of individuals with high social anxiety.
Scientific Title:Acronym Four times programs of mindfulness and cognitive behavioral therapy for social anxiety
Region
Japan

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

Objectives
Narrative objectives1 To develop the four times programs of mindfulness and cognitive behavioral therapy for social anxiety and examine its effect.
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 Speech Cost/Probability bias Scale
Japanese Version of Short Fear of Negative Evaluation Scale
Japanese Version of Self-Focused Attention Scale
Japanese Version of Subjective Happiness Scale
Japanese Version of Five Facet Mindfulness Questionnaire
Japanese Version of Self-rating depression Scale


Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 Four times programs of mindfulness and cognitive behavioral therapy for social anxiety
Interventions/Control_2 The control group does not receive the program and is assessed after the end of the intervention group's program.
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
30 years-old >=
Gender Male and Female
Key inclusion criteria 44 scores or more of Japanese Version of Liebowitz Social Anxiety Scale
60 scores or less of Japanese Version of Self-rating depression Scale
To obtain the written consent of individual
Key exclusion criteria Those who are receiving treatment in psychiatry, psychosomatic medicine, and who are receiving psychological counseling
Those who are judged to have serious illness or symptoms
Target sample size 60

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 Musashino University
Organization
Division
Category of Funding Organization Other
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
2019 Year 05 Month 16 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 Open public recruiting
Date of protocol fixation
2018 Year 09 Month 01 Day
Date of IRB
2018 Year 08 Month 06 Day
Anticipated trial start date
2018 Year 09 Month 01 Day
Last follow-up date
2020 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
2019 Year 05 Month 16 Day
Last modified on
2019 Year 05 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041893

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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