UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007007 |
|---|---|
| Receipt number | R000008181 |
| Scientific Title | 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 |
| Date of disclosure of the study information | 2012/01/07 |
| Last modified on | 2019/01/08 10:32:16 |
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Basic information
Public title
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
Acronym
A randomized controlled trial of Attention Bias Modification Treatment (ABMT) for highly anxious adults
Scientific Title
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
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Hirokuni Tagaya |
Organization
Kitasato University
Division name
Faculty of Allied Health Sciences
Zip code
Address
1-15-1, Kitasato, Sagamihara, Kanagawa, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Kitasato University
Division name
Faculty of Allied Health Sciences
Zip code
Address
1-15-1, Kitasato, Sagamihara, Kanagawa, Japan
TEL
Homepage URL
Sponsor or person
Institute
Kitasato University
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.sciencedirect.com/science/article/pii/S0165032718308255?via%3Dihub
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
| 2011 | Year | 12 | Month | 14 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008181
