UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000039327
Receipt number R000044854
Scientific Title Relationships among mindfulness, attention control function, mind wandering, and emotion
Date of disclosure of the study information 2020/01/30
Last modified on 2020/01/30 20:42:14

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Relationships among mindfulness, attention control function, mind wandering, and emotion

Acronym

Relationships among mindfulness, attention control function, mind wandering, and emotion

Scientific Title

Relationships among mindfulness, attention control function, mind wandering, and emotion

Scientific Title:Acronym

Relationships among mindfulness, attention control function, mind wandering, and emotion

Region

Japan


Condition

Condition

Healthy people

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examine the effects of mindfulness training and attention training technique on mind wandering and emotions.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Changes in mind wandering (MWQ, SART error, SART RTCV) after two weeks of training.

Key secondary outcomes

Changes in depression (BDI-II) and anxiety(STAI) after two weeks of training, and changes in mood before and after training (BMC-J).


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

3

Purpose of intervention

Treatment

Type of intervention

Behavior,custom

Interventions/Control_1

2 weeks mindfulness training

Interventions/Control_2

2 weeks attention training technique

Interventions/Control_3

No interventions

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

40 years-old >

Gender

Male and Female

Key inclusion criteria

Healthy people enrolled in Waseda University

Key exclusion criteria

/having illness or injury
/taking medicine
/feeling extreme lack of sleep or fatigue on the day of the experiment
/having psychological counseling
/having severe psychological distress or traumatic experience in the past
/participating in other intervention studies

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Kaneo
Middle name
Last name Nedate

Organization

Waseda University

Division name

Faculty of Human Science

Zip code

359-1192

Address

2-579-15, Mikajima, Tokorozawa, Saitama

TEL

04-2949-8113

Email

nedate@waseda.jp


Public contact

Name of contact person

1st name Ayumi
Middle name
Last name Umeda

Organization

Waseda University

Division name

Graduate School of Human Science

Zip code

359-1192

Address

2-579-15, Mikajima, Tokorozawa, Saitama

TEL

04-2949-8113

Homepage URL


Email

umeda-a@fuji.waseda.jp


Sponsor or person

Institute

Waseda University

Institute

Department

Personal name



Funding Source

Organization

Waseda University

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

Office of Research Ethics concerning Research with Human Subjects

Address

1-104, Totsuka-machi, Shinjuku-ku, Tokyo

Tel

03-5272-1639

Email

rinri@list.waseda.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 01 Month 30 Day


Related information

URL releasing protocol

https://www.micenavi.jp/jpa2019/search/detail_program/id:479

Publication of results

Partially published


Result

URL related to results and publications

https://www.micenavi.jp/jpa2019/search/detail_program/id:479

Number of participants that the trial has enrolled

37

Results

Only the control group had improved SART error.

Results date posted

2020 Year 01 Month 30 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Health people in Waseda University

Participant flow

Participants were randomly assigned to three groups. They participated in pre-assessment, intervention, and post-assessment.

Adverse events


Nothing

Outcome measures

mind wandering (MWQ, SART error, SART RTCV)

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2017 Year 08 Month 21 Day

Date of IRB

2017 Year 11 Month 02 Day

Anticipated trial start date

2017 Year 11 Month 09 Day

Last follow-up date

2018 Year 08 Month 09 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2020 Year 01 Month 30 Day

Last modified on

2020 Year 01 Month 30 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044854


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name