UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A randomized controlled trial of Attention Bias Modification Treatment (ABMT) for highly anxious adults: A functional MRI investigation of the neural mechanisms of the ABMT
Title of the study (Brief title)	A randomized controlled trial of Attention Bias Modification Treatment (ABMT) for highly anxious adults
Region	Japan

Condition
Condition	Anxiety
Classification by specialty	Psychiatry Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the anxiety-alleviating effect of Attention Bias Modification Treatment (ABMT) for healthy young adults with high anxiety-related personality trait using a functional magnetic resonance imaging
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Anxiety/Depressive symptoms/Personality traits/Stress responses/Endocrine responses/functional magnetic resonance imaging/cognitive functions
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Behavior,custom
Interventions/Control_1	Attention Bias Modification Treatment
Interventions/Control_2	Attention Bias Measurement Task
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	30 years-old >=
Gender	Male and Female
Key inclusion criteria	1) High score of the anxiety-related personality trait
Key exclusion criteria	1) Presence of significant psychiatric disorders determined by the Mini International Neuropsychiatric Interview 2) Presence of significant medical illnesses 3) History of traumatic brain injury 4) Patient of psychiatry 5) Psychotropic medication within the previous month 6) Over-intake of caffeine 7) Metal implants that interfere with the MRI safety 8) Pregnancy
Target sample size	50

Research contact person
Name of lead principal investigator	Hirokuni Tagaya
Organization	Kitasato University
Division name	Faculty of Allied Health Sciences
Address	1-15-1, Kitasato, Sagamihara, Kanagawa, Japan
TEL
Email

Public contact
Name of contact person
Organization	Kitasato University
Division name	Faculty of Allied Health Sciences
Address	1-15-1, Kitasato, Sagamihara, Kanagawa, Japan
TEL
Homepage URL
Email

Sponsor
Institute	Kitasato University
Institute
Department

Funding Source
Organization	1) Japan Society for the Promotion of Science 2) Kitasato University
Organization
Division
Category of Funding Organization
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	2012 Year 01 Month 07 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 12 Month 14 Day
Anticipated trial start date	2012 Year 01 Month 01 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	Published
URL releasing results	https://www.sciencedirect.com/science/article/pii/S0165032718308255?via%3Dihub
Results
Other related information

Management information
Registered date	2012 Year 01 Month 04 Day
Last modified on	2019 Year 01 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008181