UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Neural basis for Cognitive Bias Modification for Interpretation
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Ryuta Kawashima
Organization	Tohoku University
Division name	Institute of Development, Aging and Cancer
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	Kohei Sakaki
Organization	Tohoku University
Division name	Graduate School of Medicine
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
Institute	Institute of Development, Aging and Cancer, Tohoku University
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2016 Year 07 Month 12 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026932