UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055180 |
|---|---|
| Receipt number | R000063042 |
| Scientific Title | A Randomized Controlled Trial of the Efficacy of Compassionate Mind Training for Adults Who Stutter |
| Date of disclosure of the study information | 2024/08/07 |
| Last modified on | 2024/08/06 17:47:42 |
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Basic information
Public title
A Randomized Controlled Trial of the Efficacy of Compassionate Mind Training for Adults Who Stutter
Acronym
A Randomized Controlled Trial of the Efficacy of Compassionate Mind Training for Adults Who Stutter
Scientific Title
A Randomized Controlled Trial of the Efficacy of Compassionate Mind Training for Adults Who Stutter
Scientific Title:Acronym
A Randomized Controlled Trial of the Efficacy of Compassionate Mind Training for Adults Who Stutter
Region
| Japan |
Condition
Condition
Developmental stuttering
Classification by specialty
| Psychosomatic Internal Medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To identify the effectiveness of compassionate mind training for adults who stutter
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
36-Item Short-Form Health Survey (SF-36) scores in the intervention and waitlist groups
Key secondary outcomes
Comparison of the following scores between intervention and waitlist groups
1, Comprehensive Self-Acceptance Scale for Stuttering (CSASS)
2, short Japanese version of the Self-Stigma of Stuttering Scale (4S-J-16)
3, Unhelpful Thoughts and Beliefs About Stuttering (UTBAS) scales
4, Overall Assessment of the Speaker's Experience of Stuttering for Adults
5, Five Facet Mindfulness Questionnaire
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Double blind -all involved are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
YES
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Weekly online, group-based Compassion Mind Training (8 weeks, 1 hour 30 minutes per session) and Homework during the intervention period
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
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
developmental stuttering
Key exclusion criteria
1, Has not received language training or psychological intervention/treatment within the past 6 months
2, Those who do not have a serious mental disorder other than stuttering
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Shoko |
| Middle name | |
| Last name | Miyamoto |
Organization
University of Tsukuba
Division name
Institute of Human Sciences
Zip code
305-8572
Address
Tennodai, Tsukuba, Ibaraki 305-8572, Japan
TEL
029-853-5602
smymt@human.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Mizuki |
| Middle name | |
| Last name | Aoki |
Organization
University of Tsukuba
Division name
Graduate School of Comprehensive Human Sciences
Zip code
305-8572
Address
Tennodai, Tsukuba, Ibaraki 305-8572, Japan
TEL
029-853-5606
Homepage URL
s2330362@u.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
Grants-in-Aid for Scientific Research (KAKENHI)
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
Research Ethics Committee, Institute of Human Sciences, Tsukuba University
Address
1-1-1 Tennodai, Tsukuba City, Ibaraki
Tel
029-853-5605
hitorinri@un.tsukuba.ac.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
| 2024 | Year | 08 | Month | 07 | 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
| 2024 | Year | 05 | Month | 30 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 18 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 23 | Day |
Last follow-up date
| 2025 | Year | 01 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 08 | Month | 06 | Day |
Last modified on
| 2024 | Year | 08 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063042
