UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000026785
Receipt number R000030582
Scientific Title Development of the interventional program using cognitive behavior therapy (CBT) for adolescents and adults who stutter
Date of disclosure of the study information 2017/03/31
Last modified on 2022/03/15 17:23:30

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Basic information

Public title

Development of the interventional program using cognitive behavior therapy (CBT) for adolescents and adults who stutter

Acronym

CBT intervention for adolescents and adults who stutter

Scientific Title

Development of the interventional program using cognitive behavior therapy (CBT) for adolescents and adults who stutter

Scientific Title:Acronym

CBT intervention for adolescents and adults who stutter

Region

Japan


Condition

Condition

Stuttering

Classification by specialty

Psychiatry Oto-rhino-laryngology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the treatment efficacy on stuttering of group training based on cognitive behavior therapy (CBT) for adolescents and adults who stutter

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

"The Stuttering Test" before the intervention, at the end of the intervention, and one month after the end of the intervention.

Key secondary outcomes

Questionnaires filled before the intervention, at the end of the intervention, and one month after the end of the intervention (Overall Assessment of the Speaker's Experience of Stuttering (OASES), Japanese edition, Liebowitz Social Anxiety Scale in Japanese (LSAS-J), Stuttering Distress Questionnaire, Erickson Scale of Communication Attitudes, modified (S-24), Self-Assessment Scale of Speech, Preparatory behavior checklist for those who tend to stutter just before speech, Thought Chain Chart for those who stutter, UTBAS-6, General Self-Efficasy Scale(GSES), PHQ9)


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

YES

Dynamic allocation

NO

Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Other

Interventions/Control_1

Five weekly training sessions of two hours for adults and five daily sessions of two hours for the students of junior high and high schools.

Interventions/Control_2


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

70 years-old >=

Gender

Male and Female

Key inclusion criteria

Persons who stutter older than 11 years old (junior high school students and above). Those who volunteer for participating in this group training program among stuttering patients of our hospital and those who apply to the program through public recruitment.

Key exclusion criteria

Persons who can not speak at all because of severe stuttering. Persons with severe depression, or mental retardation. Persons who will not follow instructions. Persons who do not want improvement of stuttering.

Target sample size

50


Research contact person

Name of lead principal investigator

1st name Tomohito
Middle name
Last name Houjou

Organization

National Rehabilitation Center for Persons with Disabilities

Division name

Hospital

Zip code

359-8555

Address

4-1 Namiki, Tokorozawa, Saitama, 359-8555

TEL

04-2995-3100

Email

houjou-tomohito@rehab.go.jp


Public contact

Name of contact person

1st name Tomohito
Middle name
Last name Houjou

Organization

National Rehabilitation Center for Persons with Disabilities

Division name

Hospital

Zip code

359-8555

Address

4-1 Namiki, Tokorozawa, Saitama, 359-8555

TEL

04-2995-3100

Homepage URL

http://www.kitsuon-kenkyu.org/

Email

houjou-tomohito@rehab.go.jp


Sponsor or person

Institute

National Rehabilitation Center for Persons with Disabilities

Institute

Department

Personal name



Funding Source

Organization

Japan Agency for Medical Research and Development

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

IRB, National Rehabilitation Center for Persons with Disabilities

Address

4-1 Namiki, Tokorozawa, Saitama, 359-8555

Tel

04-2995-3100

Email

kikakurinri@rehab.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

2017 Year 03 Month 31 Day


Related information

URL releasing protocol

http://www.jssfd.org/dl/gakkaishi04.pdf

Publication of results

Published


Result

URL related to results and publications

http://www.jssfd.org/dl/gakkaishi04.pdf

Number of participants that the trial has enrolled

48

Results

Please see:
http://www.jssfd.org/dl/gakkaishi04.pdf

Results date posted

2022 Year 03 Month 15 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Please see:
http://www.jssfd.org/dl/gakkaishi04.pdf

Participant flow

Please see:
http://www.jssfd.org/dl/gakkaishi04.pdf

Adverse events

Please see:
http://www.jssfd.org/dl/gakkaishi04.pdf

Outcome measures

Please see:
http://www.jssfd.org/dl/gakkaishi04.pdf

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Main results already published

Date of protocol fixation

2017 Year 03 Month 15 Day

Date of IRB

2016 Year 10 Month 31 Day

Anticipated trial start date

2017 Year 03 Month 18 Day

Last follow-up date

2019 Year 09 Month 19 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2017 Year 03 Month 30 Day

Last modified on

2022 Year 03 Month 15 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030582


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name