UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036763 |
|---|---|
| Receipt number | R000041893 |
| Scientific Title | The effect of four-session program 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 | 2020/12/10 14:02:50 |
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Basic information
Public title
The effect of four-session program of mindfulness and cognitive behavioral therapy for social anxiety
Acronym
The four-session program of mindfulness and cognitive behavioral therapy for social anxiety
Scientific Title
The effect of four-session program of mindfulness and cognitive behavioral therapy for social anxiety: a pilot randomized study of individuals with high social anxiety.
Scientific Title:Acronym
The four-session program 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 a four-session program 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-session program 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
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
norashouta@outlook.jp
Sponsor or person
Institute
Musashino University
Institute
Department
Personal name
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
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
71
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
Completed
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 | 16 | 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
| 2020 | Year | 12 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041893
