UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028209
Receipt number R000032289
Scientific Title A randomized controlled trial of a Cognitive Behavioral Intervention for Anger Management
Date of disclosure of the study information 2020/04/01
Last modified on 2020/07/15 14:44:40

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Basic information

Public title

A randomized controlled trial of a Cognitive Behavioral Intervention for Anger Management

Acronym

CBT for Anger Management

Scientific Title

A randomized controlled trial of a Cognitive Behavioral Intervention for Anger Management

Scientific Title:Acronym

CBT for Anger Management

Region

Japan


Condition

Condition

healthy person

Classification by specialty

Not applicable Adult Child

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

(1)the construction of CBT based group sessions for anger
(2)the effects of this program on the anger outcomes

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

STAXI(State-Trait Anger Expression Inventory)

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Behavior,custom Other

Interventions/Control_1

Eight group 40-minutes sessions about anger problems (Intervention Group)

Interventions/Control_2

Eight group 40-minutes sessions excluding anger problems (Control Group)

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


Not applicable

Gender

Male and Female

Key inclusion criteria

(1)Undergraduates
(2)The signature on the letter of consent

Key exclusion criteria

None

Target sample size

150


Research contact person

Name of lead principal investigator

1st name Katsutoshi
Middle name
Last name Tanaka

Organization

Kitasato University Graduate School of Medical Sciences

Division name

Kitasato University Graduate School of Medical Sciences

Zip code

252-0373

Address

1-15-1 Kitasato, Sagamihara-Shi, Kanagawa, 252-0373, Japan

TEL

042-778-7962

Email

k-tanaka@kitasato-u.ac.jp


Public contact

Name of contact person

1st name Katsutoshi
Middle name
Last name Tanaka

Organization

Kitasato University Graduate School of Medical Sciences

Division name

Department of Medical Science

Zip code

252-0373

Address

1-15-1 Kitasato, Sagamihara-Shi, Kanagawa, 252-0373, Japan

TEL

042-778-7962

Homepage URL


Email

k-tanaka@kitasato-u.ac.jp


Sponsor or person

Institute

Kitasato University Graduate School of Medical Sciences

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Kitasato University Graduate School of Medical Sciences

Address

1-15-1 Kitasato, Sagamihara-Shi, Kanagawa, 252-0373, Japan

Tel

042-778-9603

Email

matsunao@kitasato-u.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

2020 Year 04 Month 01 Day


Related information

URL releasing protocol

http://mlib.kitasato-u.ac.jp/homepage/ktms/kaishi/pdf/KMJ50-1/KMJ50-1.html

Publication of results

Published


Result

URL related to results and publications

http://mlib.kitasato-u.ac.jp/homepage/ktms/kaishi/pdf/KMJ50-1/KMJ50-1.html

Number of participants that the trial has enrolled

179

Results

It was clarified that all variables had a large effect immediately after the completion of the program.
Urthermore, it was clarified that the effect was strong in 4 subscales, but not in Anger Control, at 5-6 weeks after the completion of the program. Also, the tendency to keep anger from showing was found to be slightly affected. Therefore, the results show that the effects of this program lasted for up to 5-6 weeks after the completion of the program.

Results date posted

2020 Year 07 Month 15 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

university student

Participant flow

To convey the purpose of the study, all participants received an explanation of the research outline, purpose, and various matters concerning the protection of personal information, and written consent for participation in the study was obtained from each participant. We randomly assigned participants to the intervention group and the control group using the permuted block method (block size = 2) for 179 students.

Adverse events

None

Outcome measures

STAXI

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2017 Year 07 Month 01 Day

Date of IRB

2017 Year 05 Month 29 Day

Anticipated trial start date

2017 Year 09 Month 01 Day

Last follow-up date

2018 Year 01 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

2017 Year 07 Month 13 Day

Last modified on

2020 Year 07 Month 15 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032289


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name