UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031916 |
|---|---|
| Receipt number | R000036443 |
| Scientific Title | Research on the effects of cognitive behavioral therapy for stuttering |
| Date of disclosure of the study information | 2018/03/27 |
| Last modified on | 2019/08/21 10:01:17 |
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Basic information
Public title
Research on the effects of cognitive behavioral therapy for stuttering
Acronym
Cognitive behavioral therapy for stuttering
Scientific Title
Research on the effects of cognitive behavioral therapy for stuttering
Scientific Title:Acronym
Cognitive behavioral therapy for stuttering
Region
| Japan |
Condition
Condition
Stuttering
Classification by specialty
| Psychiatry | Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To measure the effect of cognitive behavioral therapy for stuttering.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Subjective severity of stuttering using visual analog scale.
Before intervention,the halfway point, the end of intervention.
Key secondary outcomes
Liebowitz social anxiety scale-Japanese(LSAS-J)
Frequency of stuttering
Patient health quetionnaire-9(PHQ-9)
Generalized anxiety disorder-7(GAD-7)
Euro Qol 5 dimension(EQ-5D)
Fear of negative evaluation scale(FNE shortened version)
Social phobia inventory(SPIN)
Overall assessment of the speaker's experiences of stuttering(OASES Japanese version)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Cognitive behavioral therapy and speech therapy.Once in one to two weeks.
Interventions/Control_2
Speech therapy.Once in three to four weeks.
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
| 12 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Diagnosed with stuttering by otolaryngologist.
Applicable to diagnostic criteria for DSM-5.
Mental and physical conditions where cognitive behavioral therapy can be practiced for at least one years.
Key exclusion criteria
psychosis,major depression,bipolar disorder,dependence on drugs,other severe mental/ physical condition.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Omori Fukie |
Organization
Teikyo University Chiba Medical Center
Division name
Department of otolaryngology
Zip code
Address
3426-3 Anesaki,Ichihara Chiba,Japan
TEL
0436-62-1211
fukie@med.teikyo-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Omori Fukie |
Organization
Teikyo University Chiba Medical Center
Division name
Teikyo University Chiba Medical Center
Zip code
Address
3426-3 Anesaki,Ichihara Chiba,Japan
TEL
0436-62-1211
Homepage URL
fukie@med.teikyo-u.ac.jp
Sponsor or person
Institute
Teikyo University Chiba Medical Center
Department of otolaryngology
Institute
Department
Personal name
Funding Source
Organization
Teikyo University Chiba Medical Center
Department of otolaryngology
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
Address
Tel
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
| 2018 | Year | 03 | Month | 27 | 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
Completed
Date of protocol fixation
| 2018 | Year | 03 | Month | 27 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 01 | Day |
Anticipated trial start date
| 2018 | Year | 03 | Month | 27 | Day |
Last follow-up date
| 2019 | Year | 05 | 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
| 2018 | Year | 03 | Month | 27 | Day |
Last modified on
| 2019 | Year | 08 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036443
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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