UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Influence the improvement of self-compassion is on the occurrence frequency and subsequent mood of mind wandering.
Title of the study (Brief title)	Influence the improvement of self-compassion is on the occurrence frequency and subsequent mood of mind wandering.
Region	Japan

Condition
Condition	Mind-wandering
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Intervention programs in order to recharge self-compassion is, to examine the effect of the occurrence frequency of Mind-wandering, the mood after the mind-wandering occurrence.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase III

Assessment
Primary outcomes	The contents of the mind wandering , the mood at the time of mind wandering occurrence , questionnaire (own benevolence , mindfulness , depressive symptoms , anxiety symptoms , mood rating )
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	Perform in the self control. The period of intervention for individual subjects is four weeks, providing a period of time to collect the experience sampling of one week before and after the intervention. To compare the sampling after sampling and the intervention of the pre-intervention in the self control. Intervention, is scheduled to perform a total of four times the population session of about 70 minutes once per week, under the guidance of the experimenter, get carried out the work to the experimental subject. First round, it notice to myself that was the mind wandering, do their own feelings and thoughts, the work for which notice body sensation in it. The second time is asked to share a past of failed experience with a group of everyone, everyone to share that it has trouble, a failure experience. The third round is, do the work of writing a letter of the kind words over to yourself. The fourth round is carried out a review and summary of the past. To enhance the program effect, with respect to the experimental subject, impose a home work during the program period. In the sampling, it is an object of the present during the performance, the contents of the mind wandering, asked about the current mood, using a questionnaire that can be created and answer on the Internet.
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	18 years-old <=
Age-upper limit	30 years-old >
Gender	Male and Female
Key inclusion criteria	Recruit recruitment of the experimental participation in university lectures, a healthy college student consent was obtained of the experimental participation.
Key exclusion criteria	He received psychotherapy before commencement of the experiment, specific and there is a person that was given a diagnosis, a person who has had trouble in extremely depressed events and interpersonal relationships to the start of the experiment before.
Target sample size	20

Research contact person
Name of lead principal investigator	Yoshinori Ito
Organization	Faculity of Education and Graduate School of Education, University of The Ryukyus
Division name	Faculity of Education and Graduate School of Education, University of The Ryukyus
Address	Senbaru 1banchi Nishihara-cho Nakagami-gun Okinawa Japan
TEL	098-895-8423
Email	satsukiyama098@gmail.com

Public contact
Name of contact person	Satsuki Sakiyama
Organization	Faculity of Education and Graduate School of Education, University of The Ryukyus
Division name	Faculity of Education and Graduate School of Education, University of The Ryukyus
Address	Senbaru 1banchi Nishihara-cho Nakagami-gun Okinawa Japan
TEL	090-8291-8246
Homepage URL
Email	satsukiyama098@gmail.com

Sponsor
Institute	University of Ryukyu
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	JAPAN SOCIETY FOR THE PROMOTION OF SCIENCE
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	琉球大学教育学部（沖縄県）

Other administrative information
Date of disclosure of the study information	2016 Year 04 Month 15 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 10 Month 25 Day
Anticipated trial start date	2015 Year 12 Month 01 Day
Last follow-up date	2016 Year 01 Month 29 Day
Date of closure to data entry	2016 Year 01 Month 31 Day
Date trial data considered complete	2016 Year 02 Month 01 Day
Date analysis concluded	2016 Year 03 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 04 Month 10 Day
Last modified on	2016 Year 04 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-bin/ctr_e/ctr_view.cgi?recptno=R000024809