UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043002 |
|---|---|
| Receipt number | 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 10:42:27 |
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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
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
haitani-tomosumi@rehab.go.jp
Sponsor or person
Institute
Research institute, National Rehabilitation Center for Persons with Disabilities
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049094
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
