UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041341 |
|---|---|
| Receipt number | R000047072 |
| Scientific Title | Functional MRI study of treatment mechanisms of Eye Movement Desensitization and Reprocessing for Posttraumatic stress symptoms |
| Date of disclosure of the study information | 2020/08/10 |
| Last modified on | 2021/02/06 15:28:39 |
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Basic information
Public title
Functional MRI study of treatment mechanisms of Eye Movement Desensitization and Reprocessing for Posttraumatic stress symptoms
Acronym
Functional MRI study of treatment mechanisms of EMDR for PTSS
Scientific Title
Functional MRI study of treatment mechanisms of Eye Movement Desensitization and Reprocessing for Posttraumatic stress symptoms
Scientific Title:Acronym
Functional MRI study of treatment mechanisms of EMDR for PTSS
Region
| Japan |
Condition
Condition
Posttraumatic stress symptoms
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effectiveness on brain function of Eye Movement Desensitization and Reprocessing(EMDR) for patients with posttraumatic stress symptoms who have traumatic experiences that do not meet the A criterion for PTSD in DSM-5.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
resting-state fMRI before and after EMDR treatment
Key secondary outcomes
Clinician-Administered PTSD
Dissociative Experiences Scale-2
Impact of Event Scale-revised
Beck Depression Inventory-2
State-Trait Anxiety Inventory
Posttraumatic Cognition Inventory
Multidimensional Assessment of Interoceptive Awareness
Toronto Alexithymia Scale
MRI
T1-weighted image
T2-weighted image
1H-MRS
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
3
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Participants are divided into the PTSS group, PTSD group and healthy control.
PTSS group: patients with post-traumatic stress symptoms(PTSS) who have traumatic experiences that do not meet the A criterion for PTSD in DSM-5
PTSS group
EMDR(maximum 15 sessions(60-90 minute) once every 1-2 weeks) and treatment as usual
Interventions/Control_2
PTSD group
EMDR(maximum 15 sessions(60-90 minute) once every 1-2 weeks) and treatment as usual
Interventions/Control_3
healthy control
no treatment
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
| 55 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
PTSS group
1.Aged 20 to 55 years old.
2.Subjects who have traumatic experiences that do not meet the A criterion for PTSD in DSM-5.
3.Subjects who meet two or more of the B-E criteria for PTSD in DSM-5 and who meet the F and G criteria.
4.Intelligent quotient above 80 by JART.
5.Subjects who give full consent in the participation of the study.
PTSD group
1.Aged 20 to 55 years old.
2.Subjects who meet the diagnostic criteria for PTSD in DSM-5 as a primary diagnostic.
3.Intelligent quotient above 80.
4.Subjects who give full consent in the participation of the study.
healthy control
1.Aged 20 to 55 years old.
2.Intelligent quotient above 80.
3.Subjects who give full consent in the participation of the study.
Key exclusion criteria
PTSS group
1.Prior treatment of EMDR.
2.Subjects who have a high urgency for treatment, such as an imminent suicide attempt.
3.Subjects with intracranial occupational lesions or vascular lesions such as cerebral infarction.
4.Subjects with neurological diseases such as epilepsy.
5.MRI contraindicated.
6.Pregnancy or possible pregnancy.
PTSD group
1.Prior treatment of EMDR.
2.Subjects whose main diagnosis is mental disorders other than PTSD.
3.Subjects who have a high urgency for treatment, such as an imminent suicide attempt.
4.Subjects with intracranial occupational lesions or vascular lesions such as cerebral infarction.
5.Subjects with neurological diseases such as epilepsy.
6.MRI contraindicated.
7.Pregnancy or possible pregnancy.
healthy control
1.Subjects who suspected of mental disorder by M.I.N.I
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | Jun |
| Middle name | |
| Last name | Inoue |
Organization
Hamamatsu University School of Medicine
Division name
Department of Child and Adolescent Psychiatry
Zip code
431-3192
Address
1-20-1 Handayama, Higashi-Ku, Hamamatsu city, Shizuoka 431-3192, Japan
TEL
053-435-2058
juninoue@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | Jun |
| Middle name | |
| Last name | Inoue |
Organization
Hamamatsu University School of Medicine
Division name
Department of Child and Adolescent Psychiatry
Zip code
431-3192
Address
1-20-1 Handayama, Higashi-Ku, Hamamatsu city, Shizuoka 431-3192, Japan
TEL
053-435-2058
Homepage URL
juninoue@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hamamatsu University School of Medicine
Address
1-20-1 Handayama, Higashi-Ku, Hamamatsu city, Shizuoka 431-3192, Japan
Tel
053-435-2680
rinri@hama-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
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 08 | Month | 10 | 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
| 2020 | Year | 07 | Month | 21 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 21 | Day |
Anticipated trial start date
| 2020 | Year | 08 | Month | 13 | Day |
Last follow-up date
| 2025 | Year | 07 | 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
| 2020 | Year | 08 | Month | 06 | Day |
Last modified on
| 2021 | Year | 02 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047072
