UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000045513
Receipt number R000051950
Scientific Title A qualitative study of semi-structured interviews on shame and compassionate memories as a medical history interview of depressed patients and their relation to fear of compassion.
Date of disclosure of the study information 2021/09/25
Last modified on 2024/03/21 11:21:58

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Basic information

Public title

A qualitative study of semi-structured interviews on shame and compassionate memories as a medical history interview of depressed patients and their relation to fear of compassion.

Acronym

Interview study on shame memory and compassionate memory in depression

Scientific Title

A qualitative study of semi-structured interviews on shame and compassionate memories as a medical history interview of depressed patients and their relation to fear of compassion.

Scientific Title:Acronym

Interview study on shame memory and compassionate memory in depression

Region

Japan


Condition

Condition

major depressive disorder

Classification by specialty

Hepato-biliary-pancreatic medicine Psychosomatic Internal Medicine Psychiatry

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

An examination of the effects of shame and compassionate memories on depression, fear of compassion and feelings of shame.

Basic objectives2

Others

Basic objectives -Others

none

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

BDI-2, fear of compassion scale, external and internal shame scale

Key secondary outcomes



Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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

60 years-old >=

Gender

Male and Female

Key inclusion criteria

major depressive disorder

Key exclusion criteria

Risk of suicide Severe
schizophrenia
Dementia

Target sample size

16


Research contact person

Name of lead principal investigator

1st name Yoichi
Middle name
Last name Hiramatsu

Organization

Research center for child mental development chiba university

Division name

Research center for child mental development

Zip code

260-8670

Address

inohana1-8-1, chuoku, chiba city, chiba

TEL

043-226-2975

Email

hfcjf228@ybb.ne.jp


Public contact

Name of contact person

1st name Yoichi
Middle name
Last name Hiramatsu

Organization

Research center for child mental development chiba university

Division name

Research center for child mental development chiba university

Zip code

260-8670

Address

inohana1-8-1, chuoku, chiba city, chiba

TEL

043-226-2975

Homepage URL


Email

hfcjf228@ybb.ne.jp


Sponsor or person

Institute

chiba university

Institute

Department

Personal name



Funding Source

Organization

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

Research center for child mental development chiba university

Address

inohana1-8-1, chuoku, chiba city, chiba

Tel

043-226-2975

Email

hfcjf228@ybb.ne.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

2021 Year 09 Month 25 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

Suspended

Date of protocol fixation

2020 Year 11 Month 30 Day

Date of IRB

2020 Year 11 Month 30 Day

Anticipated trial start date

2021 Year 05 Month 01 Day

Last follow-up date

2024 Year 03 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

none


Management information

Registered date

2021 Year 09 Month 18 Day

Last modified on

2024 Year 03 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051950