UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024087 |
|---|---|
| Receipt number | R000027729 |
| Scientific Title | The effectiveness of cognitive behavioral therapy and the alternation of brain magnetic resonance imaging. |
| Date of disclosure of the study information | 2016/09/20 |
| Last modified on | 2025/09/25 16:49:35 |
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Basic information
Public title
The effectiveness of cognitive behavioral therapy and the alternation of brain magnetic resonance imaging.
Acronym
The effectiveness of CBT and the alternation of brain MRI.
Scientific Title
The effectiveness of cognitive behavioral therapy and the alternation of brain magnetic resonance imaging.
Scientific Title:Acronym
The effectiveness of CBT and the alternation of brain MRI.
Region
| Japan |
Condition
Condition
Depression
Anxiety disorder
Obsessive compulsive disorder
Autism spectrum disorder
Attention deficit/hyper activity disorder
Adjustment Disorder
Feeding or eating disorders
Somatic Symptom Disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine efficacy of brain MRI as the biological parameter to evaluate the effectiveness of CBT for patients with depression, anxiety disorder, obsessive compulsive disorder, autism spectrum disorder, attention deficit/hyper activity disorder, adjustment disorder, feeding or eating disorders, and somatic symptom disorder.
Basic objectives2
Others
Basic objectives -Others
To reveal the characteristics of the brain MRI of patients with depression, anxiety disorder, obsessive compulsive disorder, autism spectrum disorder, and attention deficit/hyper activity disorder, adjustment disorder, feeding or eating disorders, somatic symptom disorder.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
PHQ-9:Patient Health Questionnaire
GAD-7:Generalized Anxiety Disorder
Key secondary outcomes
Beck Depression Inventory 2nd :BDI-II
Liebowitz Social Anxiety Scale :LSAS
Obsessive Compulsive Inventory :OCI
Autism-Spectrum Quotient :AQ-50
EuroQol 5 Dimension :EQ-5D
Brain MRI Resting-state functional MRI, T1-weighted image, Diffusion tensor imaging Cognitive function test
The following items are used according to the age and the disorder of a subject.
STAI
SCAS
OCD-CV
MOCI
Y-BOCS
CY-BOCS
DY-BOCS
SCSQ
AQ Children's version
PARS
ADOS
ADI-R
Vineland-II
RAADS-14
ADHD-RS
FAD
SSS
CBCL
BAI
SDS
DSRS
SCQ
SRS
YSQ
SMI
Fear of Compassion Scale
DOCS
OBQ-44
SI-R
PedsQL
C-OCI
RBS-R
QCD
General Questionnaire Sheet Ministry of Health, Labour and Welfare in Japan, Standard health screening and health guidance program
IES-R
Structured Clinical Interview For DSM-5 Disorders Research Version
IPAQ, short version, usual week
ERQ-CA
EAC-C
EAC-A
Japanese Version of the Highly Sensitive Person Scale
DASS-21
AIS
ISI
EDEQ
EDE 17.0D ver.
MCQ-30
BCQ
BSQ
MSPQ
GCS
CGI-S
BPI-J
PHQ-A
ECR-RC9
CSQ-8J
TKSS, Japanese version
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Cognitive behavioral therapy
From 12 to 35 times
Interventions/Control_2
No treatment
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
| 7 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Patient with depression, anxiety disorder, obsessive compulsive disorder, autism spectrum disorder and attention deficit/hyper activity disorder, and adjustment disorder diagnosed by DSM-IV-TR , DSM-5, DSM-5-TR.
2)Healthy control
3)People with subthreshold anxiety: those who have more than moderate or greater symptoms measured by LSAS, or any new student who answers "yes" to anxiety symptoms on the mental health checkup questionnaire and shows moderate or higher anxiety as measured by STAI questionnaire in the post-checkup interview.
Key exclusion criteria
1)organic brain disorder
2)active suicidality
3)antisocial personality disorder
4)other severe mental / physical condition
Target sample size
1100
Research contact person
Name of lead principal investigator
| 1st name | Eiji |
| Middle name | |
| Last name | Shimizu |
Organization
Graduate School of Medicine Chiba University
Division name
Department of Cognitive Behavioral Physiology, Research Center for Child Mental Development
Zip code
260-8670
Address
1-8-1 Inohana, Chuou-ku, Chiba, Japan
TEL
043-226-2027
eiji@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | Yoshiyuki |
| Middle name | |
| Last name | Hirano |
Organization
Research Center for Child Mental Development Chiba University
Division name
Department of Cognitive Information Technology
Zip code
260-8670
Address
1-8-1 Inohana, Chuou-ku, Chiba, Japan
TEL
043-226-2975
Homepage URL
hirano@chiba-u.jp
Sponsor or person
Institute
Department of Cognitive Behavioral Physiology, Graduate School of Medicine, Research Center for Child Mental Development, Chiba University
Institute
Department
Personal name
Funding Source
Organization
Department of Cognitive Behavioral Physiology, Graduate School of Medicine, Research Center for Child Mental Development, Chiba University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethics Council of the Graduate School of Medicine, Chiba University
Address
1-8-1 Inohana, Chuou-ku, Chiba, Japan
Tel
043-222-7171
igaku-rinri@office.chiba-u.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
| 2016 | Year | 09 | Month | 20 | 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
Open public recruiting
Date of protocol fixation
| 2015 | Year | 08 | Month | 31 | Day |
Date of IRB
| 2015 | Year | 08 | Month | 31 | Day |
Anticipated trial start date
| 2015 | Year | 09 | Month | 17 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 09 | Month | 16 | Day |
Last modified on
| 2025 | Year | 09 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027729
