UMIN-CTR Clinical Trial

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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