UMIN-CTR Clinical Trial

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
Institute	Tanamura internal medicine, pediatrics clinic
Institute
Department

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000022338