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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000031916
Receipt No. 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

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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
Email 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
Email fukie@med.teikyo-u.ac.jp

Sponsor
Institute Teikyo University Chiba Medical Center
Department of otolaryngology
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036443

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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