UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022966
Receipt number R000026425
Scientific Title Investigation of the treatment mechanisms of mindfulness programs
Date of disclosure of the study information 2016/07/01
Last modified on 2020/07/23 17:54:00

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Basic information

Public title

Investigation of the treatment mechanisms of mindfulness programs

Acronym

Investigation of the treatment mechanisms of mindfulness programs

Scientific Title

Investigation of the treatment mechanisms of mindfulness programs

Scientific Title:Acronym

Investigation of the treatment mechanisms of mindfulness programs

Region

Japan


Condition

Condition

depression, anxiety

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To clarify how eight-week mindfulness program for patients of mental illness effects to their mind-wandering, depression, and anxiety.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Below outcomes at after the intervention and follow-up
Japanese Version of Beck Depression Inventory-2
Japanese Version of State-Trait Anxiety Inventory
Electroencephalogram, relates to mind-wandering

Key secondary outcomes

Below outcomes at after the intervention and follow-up
Japanese Version of Five Facet Mindfulness Questionnaire
Japanese Version of Mindful Attention Awareness Scale
Japanese Version of Mind-Wandering Questionnaire
The short form of the Japanese version of the Self-Compassion Scale
Japanese Version of BIS/BAS scales


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Behavior,custom Maneuver

Interventions/Control_1

Eight-mindfulness program

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

65 years-old >=

Gender

Male and Female

Key inclusion criteria

People who complains depression or anxiety.

Key exclusion criteria

People who diagnosed or suspected by M.I.N.I. as below diseases

Personality disorder, eating disorder, bipolar 1 disorder, bipolar 2 disorder (manic phase), schizophrenia, autism spectrum disorder, ADHD, obsessive-compulsive disorder, PTSD

Target sample size

20


Research contact person

Name of lead principal investigator

1st name Hiroaki
Middle name
Last name Kumano

Organization

Waseda University

Division name

Faculty of Human Science

Zip code

359-1192

Address

2-579-15, Mikajima, Tokorozawa, Saitama

TEL

04-2949-8113(8321)

Email

hikumano@waseda.jp


Public contact

Name of contact person

1st name Toru
Middle name
Last name Takahashi

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(8321)

Homepage URL


Email

totakahashi@akane.waseda.jp


Sponsor or person

Institute

Waseda University

Institute

Department

Personal name



Funding Source

Organization

Waseda University

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

Waseda University

Address

2-579-15, Mikajima, Tokorozawa, Saitama

Tel

04-2949-8113(8321)

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

2016 Year 07 Month 01 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

2016 Year 07 Month 30 Day

Date of IRB

2016 Year 07 Month 02 Day

Anticipated trial start date

2016 Year 07 Month 23 Day

Last follow-up date

2018 Year 10 Month 13 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2016 Year 07 Month 01 Day

Last modified on

2020 Year 07 Month 23 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026425


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name