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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000041341
Receipt No. 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

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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
Email 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
Email juninoue@hama-med.ac.jp

Sponsor
Institute Hamamatsu University School of Medicine
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047072

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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