UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022114
Receipt number R000025492
Scientific Title Compassion Mind Training for Major Depression.
Date of disclosure of the study information 2016/05/10
Last modified on 2019/05/02 11:46:57

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Basic information

Public title

Compassion Mind Training for Major Depression.

Acronym

Compassion Mind Training for Major Depression.

Scientific Title

Compassion Mind Training for Major Depression.

Scientific Title:Acronym

Compassion Mind Training for Major Depression.

Region

Japan


Condition

Condition

Major Depression

Classification by specialty

Psychosomatic Internal Medicine Psychiatry

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To estimate effect size and feasibility of Compassion Mind Training for Major Depression

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

BDI-II

Key secondary outcomes

Self-Compassion Scale - Japanese
Fear of Compassion Scale Japanese version


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

Interventions/Control_1

Compassion Mind Training (Group)

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

20 years-old <=

Age-upper limit

65 years-old >=

Gender

Male and Female

Key inclusion criteria

Primary diagnosis of Major Depressive Disorders (Mini-international Neuropsychiatric Interview)

Key exclusion criteria

psychotic disorder
active suicidality
organic brain disorder
antisocial personality disorder
other severe mental / physical condition

Target sample size

10


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kenichi Asano

Organization

Chiba University

Division name

Research Center for Child Mental Development

Zip code


Address

1-8-1, inohana, Chuo-ku, Chiba city

TEL

043-226-2975

Email

kenichi.asano1225@gmail.com


Public contact

Name of contact person

1st name
Middle name
Last name Kenichi Asano

Organization

Chiba University

Division name

Research Center for Child Mental Development

Zip code


Address

1-8-1, inohana, Chuo-ku, Chiba city

TEL

043-226-2975

Homepage URL


Email

kenichi.asano1225@gmail.com


Sponsor or person

Institute

Chiba University

Institute

Department

Personal name



Funding Source

Organization

The Ministry of Education, Culture, Sports,Science and Technology

Organization

Division

Category of Funding Organization

Japanese Governmental office

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



Other administrative information

Date of disclosure of the study information

2016 Year 05 Month 10 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 04 Month 01 Day

Date of IRB

2016 Year 04 Month 06 Day

Anticipated trial start date

2016 Year 04 Month 28 Day

Last follow-up date

2019 Year 03 Month 31 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 04 Month 28 Day

Last modified on

2019 Year 05 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025492


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name