UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000021858
Receipt number R000024809
Scientific Title Influence the improvement of self-compassion is on the occurrence frequency and subsequent mood of mind wandering.
Date of disclosure of the study information 2016/04/15
Last modified on 2016/04/10 18:31:23

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Basic information

Public title

Influence the improvement of self-compassion is on the occurrence frequency and subsequent mood of mind wandering.

Acronym

Influence the improvement of self-compassion is on the occurrence frequency and subsequent mood of mind wandering.

Scientific Title

Influence the improvement of self-compassion is on the occurrence frequency and subsequent mood of mind wandering.

Scientific Title:Acronym

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



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



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

1st name
Middle name
Last name 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

Zip code


Address

Senbaru 1banchi Nishihara-cho Nakagami-gun Okinawa Japan

TEL

098-895-8423

Email

satsukiyama098@gmail.com


Public contact

Name of contact person

1st name
Middle name
Last name 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

Zip code


Address

Senbaru 1banchi Nishihara-cho Nakagami-gun Okinawa Japan

TEL

090-8291-8246

Homepage URL


Email

satsukiyama098@gmail.com


Sponsor or person

Institute

University of Ryukyu

Institute

Department

Personal name



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)



IRB Contact (For public release)

Organization


Address


Tel


Email



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


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 25 Day

Date of IRB


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


Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024809


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name