UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000019563
Receipt number R000022338
Scientific Title A comparative investigation about "behavior change" effect of listen to "reason of change as motivational interviewing methods" vs "reason of no change as CBT methods"
Date of disclosure of the study information 2015/10/29
Last modified on 2019/11/01 10:30:38

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Basic information

Public title

A comparative investigation about "behavior change" effect of listen to "reason of change as motivational interviewing methods" vs "reason of no change as CBT methods"

Acronym

Effect of listen to "reason of change as motivational interviewing methods" vs "reason of no change as CBT methods"

Scientific Title

A comparative investigation about "behavior change" effect of listen to "reason of change as motivational interviewing methods" vs "reason of no change as CBT methods"

Scientific Title:Acronym

Effect of listen to "reason of change as motivational interviewing methods" vs "reason of no change as CBT methods"

Region

Japan


Condition

Condition

behavioral change

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examine whether asking reason for behaviour change in motivational interviewing (MI) can improve motivation for behaviour change.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

their level of perceived importance and confidence to behaviour change

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Cluster

Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation

NO

Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Behavior,custom

Interventions/Control_1

Intervention we performed for each workshop.
To divide groups(participants) into pairs.They conducted interview which either interview A:"Interview based on a manual to ask why and how of change(5 minutes)", interview B: "Interview based on a manual to ask the failure of change(5 minutes) " is performed alternatively.
Next then, in the same way, the other interview is performed alternately.
Evaluation point
1. last-minute first interview session
2. Immediately after first interview session
3. Immediately after second interview session

Interventions/Control_2

Before the first workshop, computers generate random number for decide whether to perform either of the interview ahead.
Second workshop or later, at last-minute the workshop, to select which either the interview more less number of samples.
Respectively, to end the data collection reaches the 100 or more cases.We roughly scheduled for 1 year.

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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Participants in the workshop for behavior change

Key exclusion criteria

A person who has knowledge of motivational interviewing method

Target sample size

200


Research contact person

Name of lead principal investigator

1st name Makiko
Middle name
Last name Sampei

Organization

Tanamura internal medicine, pediatrics clinic

Division name

department of counseling

Zip code

260-0021

Address

2-5-21 shinjyuku chuou-ku Chiba city Chiba prefecture Japan

TEL

+81-43-241-3912

Email

msampei.tky@gmail.com


Public contact

Name of contact person

1st name Makiko
Middle name
Last name Sampei

Organization

Tanamura internal medicine, pediatrics clinic

Division name

department of counseling

Zip code

260-0021

Address

2-5-21 shinjyuku chuou-ku Chiba city Chiba prefecture Japan

TEL

+81-43-241-3912

Homepage URL


Email

msampei.tky@gmail.com


Sponsor or person

Institute

Tanamura internal medicine, pediatrics clinic

Institute

Department

Personal name



Funding Source

Organization

NO

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

Tanamura internal medicine, pediatrics clinic

Address

2-5-21 shinjyuku chuou-ku Chiba city Chiba prefecture Japan

Tel

+81-43-241-3912

Email

msampei.tky@gmail.com


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

2015 Year 10 Month 29 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

2015 Year 10 Month 11 Day

Date of IRB

2015 Year 11 Month 30 Day

Anticipated trial start date

2015 Year 10 Month 30 Day

Last follow-up date

2018 Year 08 Month 24 Day

Date of closure to data entry

2018 Year 10 Month 03 Day

Date trial data considered complete

2019 Year 03 Month 17 Day

Date analysis concluded

2019 Year 12 Month 05 Day


Other

Other related information



Management information

Registered date

2015 Year 10 Month 29 Day

Last modified on

2019 Year 11 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022338


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name