UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062966 |
|---|---|
| Receipt number | R000072074 |
| Scientific Title | A Study on the Efficacy of TF-CBT for Trauma-Related Disorders Caused by Disasters and Other Traumatic Events, Using Brain Imaging |
| Date of disclosure of the study information | 2026/09/18 |
| Last modified on | 2026/09/17 17:27:51 |
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Basic information
Public title
A Study on the Efficacy of TF-CBT for Trauma-Related Disorders Caused by Disasters and Other Traumatic Events, Using Brain Imaging
Acronym
A Study Using Brain Imaging to Examine the Efficacy of TF-CBT for Trauma-Related Disorders Such as Those Resulting from Disasters
Scientific Title
A Study on the Efficacy of TF-CBT for Trauma-Related Disorders Caused by Disasters and Other Traumatic Events, Using Brain Imaging
Scientific Title:Acronym
A Study Using Brain Imaging to Examine the Efficacy of TF-CBT for Trauma-Related Disorders Such as Those Resulting from Disasters
Region
| Japan |
Condition
Condition
Trauma-related disorders
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study to examine whether the therapeutic effects of TF-CBT are reflected in biological changes in the brain.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes in brain images acquired using diffusion kurtosis imaging (DKI) before and after intervention
Key secondary outcomes
1. Severity of PTSD symptoms as measured by the UCLA PTSD-RI
2. Assessment of social functioning using the C-GAS
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
TF-CBT is a proven psychotherapy that involves 8 to 18 weekly 80- to 90-minute sessions with a practitioner (hereinafter referred to as the therapist). The program consists of child sessions, parent sessions, and joint parent-child sessions; however, until the middle of the program, sessions are conducted separately for parents and children (child sessions and parent sessions), and toward the end, the child and parent come together in joint sessions to share what they have learned and the outcomes achieved through the program. The frequency of sessions is adjusted flexibly to suit each individual case.
Interventions/Control_2
Patients are placed on a waiting list for TF-CBT and, while receiving standard treatment such as supportive psychotherapy, await their turn to be transferred to the treatment group.
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
| 6 | years-old | <= |
Age-upper limit
| 18 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Has been diagnosed with PTSD or a trauma-related disorder.
2. Have a parent or other caretaker who is available in treatment sessions.
3. Fixed medication regimen for at least 4 weeks prior to the treatment.
Key exclusion criteria
1. Comorbidity of active psychotic symptoms and/or substance abuse.
2. Presence of severe depressive symptoms and/or serious suicidal risk.
3. Presence of oppositional attitude, severe aggression and/or antisocial behaviors.
4. parent of a caretaker who will participant in treatment has 1,2or3.
Target sample size
46
Research contact person
Name of lead principal investigator
| 1st name | Junko |
| Middle name | |
| Last name | Yagi |
Organization
Iwate Medical University
Division name
Division of Child and Adolescent Psychiatry, Department of Neuropsychiatry, School of Medicine
Zip code
028-3694
Address
1-1-1 Idaidori,Yahaba-Cho, Shiwa-Gun, Iwate 028-3694
TEL
019-651-5111
junyagi@iwate-med.ac.jp
Public contact
Name of contact person
| 1st name | Junko |
| Middle name | |
| Last name | Yagi |
Organization
Iwate Medical University
Division name
Division of Child and Adolescent Psychiatry, Department of Neuropsychiatry, School of Medicine
Zip code
028-3694
Address
1-1-1 Idaidori,Yahaba-Cho, Shiwa-Gun, Iwate 028-3694
TEL
019-651-5111
Homepage URL
junyagi@iwate-med.ac.jp
Sponsor or person
Institute
Iwate Medical University
Institute
Department
Personal name
Funding Source
Organization
Iwate Medical University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Iwate Children's Mental Health Care Center
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Iwate Med U School of Medicine IRB
Address
1-1-1 Idaidori,Yahaba-Cho, Shiwa-Gun, Iwate 028-3694
Tel
019-651-5111
kenkyu-rinri@j.iwate-med.ac.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
岩手医科大学附属病院、いわてこどもケアセンター（岩手県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 09 | Month | 18 | 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
68
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
No longer recruiting
Date of protocol fixation
| 2016 | Year | 03 | Month | 20 | Day |
Date of IRB
| 2016 | Year | 05 | Month | 28 | Day |
Anticipated trial start date
| 2016 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2027 | 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
| 2026 | Year | 09 | Month | 17 | Day |
Last modified on
| 2026 | Year | 09 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072074
