UMIN-CTR Clinical Trial

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