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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000043002
Receipt No. R000049094
Scientific Title Effects of mindfulness training on psycho-behavioral aspects and daily communications in people who stutter
Date of disclosure of the study information 2021/01/14
Last modified on 2021/01/14

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Basic information
Public title Effects of mindfulness training on psycho-behavioral aspects and daily communications in people who stutter
Acronym Study on brief mindfulness training in stuttering
Scientific Title Effects of mindfulness training on psycho-behavioral aspects and daily communications in people who stutter
Scientific Title:Acronym Study on brief mindfulness training in stuttering
Region
Japan

Condition
Condition stuttering
Classification by specialty
Psychosomatic Internal Medicine Oto-rhino-laryngology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Identifying efficacy of brief mindfulness training in people who stutter
Basic objectives2 Others
Basic objectives -Others Investigating changes in social interaction situations in daily lives and process of the changes of people who stutter through brief mindfulness training
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Scores of the Japanese version of the Overall Assessment of the Speaker's Experience of Stuttering (pre and post 8-week intervention)
Key secondary outcomes Stuttering severity (pre and post 8-week intervention)
Scores of the Liebowitz social anxiety scale (pre and post 8-week intervention)
Psycho-behavioral aspects in social interaction situations measured through ecological momentary assessments (pre and post 8-week intervention)
Psycho-behavioral aspects measured through daily diary methods (during 8-week intervention)

Base
Study type Interventional

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

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 Mindfulness training through guidance audio source (8-weeks and 20 minutes per day)
Interventions/Control_2 waiting
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
65 years-old >
Gender Male and Female
Key inclusion criteria being judged to have stuttering
Key exclusion criteria 1. receiving continuous treatments of mental disorders or stuttering
2. taking medicine for mental disorders
3. having severe mental disorders other than stuttering
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Tomosumi
Middle name
Last name Haitani
Organization National Rehabilitation Center for Persons with Disabilities
Division name Research institute
Zip code 3598555
Address 4-1 Namiki, Tokorozawa, Saitama
TEL 04-2995-3100
Email haitani-tomosumi@rehab.go.jp

Public contact
Name of contact person
1st name Tomosumi
Middle name
Last name Haitani
Organization National Rehabilitation Center for Persons with Disabilities
Division name Research institute
Zip code 3598555
Address 4-1 Namiki, Tokorozawa, Saitama
TEL 04-2995-3100
Homepage URL
Email haitani-tomosumi@rehab.go.jp

Sponsor
Institute Research institute, National Rehabilitation Center for Persons with Disabilities
Institute
Department

Funding Source
Organization Research institute, National Rehabilitation Center for Persons with Disabilities
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 National Rehabilitation Center for Persons with Disabilities
Address 4-1 Namiki, Tokorozawa, Saitama
Tel 04-2995-3100
Email kikakurinnri@mhlw.go.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

Other administrative information
Date of disclosure of the study information
2021 Year 01 Month 14 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
2019 Year 05 Month 09 Day
Date of IRB
2019 Year 05 Month 29 Day
Anticipated trial start date
2019 Year 11 Month 26 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 01 Month 14 Day
Last modified on
2021 Year 01 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049094

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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