UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000023374
Receipt number R000026932
Scientific Title Neural basis for Cognitive Bias Modification for Interpretation
Date of disclosure of the study information 2016/08/01
Last modified on 2016/07/28 16:39:00

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Basic information

Public title

Neural basis for Cognitive Bias Modification for Interpretation

Acronym

Neural basis for Cognitive Bias Modification for Interpretation

Scientific Title

Neural basis for Cognitive Bias Modification for Interpretation

Scientific Title:Acronym

Neural basis for Cognitive Bias Modification for Interpretation

Region

Japan


Condition

Condition

none

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Understanding neural basis for cognitive bias modification for interpretation

Basic objectives2

Others

Basic objectives -Others

Basic natural science

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Regional brain activity changes correlated to increase of positive interpretation of ambiguous social situations

Key secondary outcomes

Social anxiety, Depression, Personality traits


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Behavior,custom

Interventions/Control_1

Imagining ambiguous social scenarios followed positive outcome, ~1 hour/day, 4 days/2 weeks

Interventions/Control_2

Imagining consistently positive social scenarios, ~1 hour/day, 4 days/2 weeks

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

Healthy university students, Social anxiety tendency (More than 17 points of Fear of Negative Evaluation Scale)

Key exclusion criteria

MRI contraindication
Auditory inability
left handedness
Past history of neurological illness

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Ryuta Kawashima

Organization

Tohoku University

Division name

Institute of Development, Aging and Cancer

Zip code


Address

Seiryo-machi 4-1, Aoba-ku, Sendai 980-8575

TEL

022-717-7988

Email

fbi@idac.tohoku.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kohei Sakaki

Organization

Tohoku University

Division name

Graduate School of Medicine

Zip code


Address

Seiryo-machi 2-1, Aoba-ku, Sendai 980-8575

TEL

022-717-8585

Homepage URL


Email

kohei.sakaki.q1@dc.tohoku.ac.jp


Sponsor or person

Institute

Institute of Development, Aging and Cancer, Tohoku University

Institute

Department

Personal name



Funding Source

Organization

Tohoku 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


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 08 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

Preinitiation

Date of protocol fixation

2016 Year 07 Month 12 Day

Date of IRB


Anticipated trial start date

2016 Year 08 Month 15 Day

Last follow-up date


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 28 Day

Last modified on

2016 Year 07 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026932


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name