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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000025267
Receipt No. R000027980
Scientific Title Reliability and validity of TSQ Japanese version in patients with psychotic disorders
Date of disclosure of the study information 2016/12/14
Last modified on 2018/04/11

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Basic information
Public title Reliability and validity of TSQ Japanese version in patients with psychotic disorders
Acronym Reliability and validity of TSQ Japanese version in patients with psychotic disorders
Scientific Title Reliability and validity of TSQ Japanese version in patients with psychotic disorders
Scientific Title:Acronym Reliability and validity of TSQ Japanese version in patients with psychotic disorders
Region
Japan

Condition
Condition a psychotic disorder or a mood disorder with psychotic features
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Patients with psychosis, such as schizophrenia, often have a pre-onset history of trauma. After the onset of the disease, they often experience traumatic events, too. For example, in a meta-analysis by Achim et al (2011), the prevalence rate of posttraumatic stress disorder (PTSD) in psychosis was estimated to be 12.4%. In Japan, psychiatrists often miss these traumas and PTSD of psychosis in clinical settings. Besides, assessment, diagnosis, treatment, and support may not be supplied appropriately.
Trauma Screening Questionnaire (TSQ) is a brief screening instrument of PTSD, developed by Brewin (2002). In this study, we will test the reliability and validity of TSQ Japanese version in patients with psychotic disorders. It is expected that with the development of TSQ Japanese version, psychiatrists will be able to screen and assess the PTSD of psychosis proactively and reveal the problems of trauma and PTSD.
Basic objectives2 Others
Basic objectives -Others reliabirity and validity of TSQ Japanese version
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes reliabirity and validity of TSQ Japanese version
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Other
Interventions/Control_1 For testing the predictive validity, we will administer the TSQ Japanese version and Clinician-Administered PTSD Scale for DSM-5(CAPS-5) in the same day to 75 subjects, taking into account their most stressful traumatic event in the past.
We will administer TSQ Japanese version two times in one week intervals to 20 out of 75 subjects, as a way to evaluate retest reliability of the scale. In this case, we will conduct CAPS-5 in the same day with second assessment of TSQ Japanese version.
Interventions/Control_2
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
59 years-old >=
Gender Male and Female
Key inclusion criteria A)Diagnosis of a psychotic disorder or mood disorder with psychotic features according to the Mini-International Neuropsychiatric Interview(M.I.N.I) japanese version 5.0.0.
B)Age 20 to 59 years.
C)Psychiatric outpatient or inpatient.
D)Previous exposure to at least one traumatic event according to criteria from the DSM-5.
E)A native speaker of Japanese.
Key exclusion criteria A)Intellectual disability(DSM-5).
B)Organic brain syndrome.
C)Being incapable of conducting interview due to extremely high suicidal risk, excitement, physical status and so on.
D)Being hospitalised forcibly.
Target sample size 75

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazunori Matsumoto
Organization Tohoku University Graduate School of Medicine
Division name Department of Psychiatry
Zip code
Address 1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8574
TEL 022-717-7262
Email kaz-mat@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazuho Tomimoto
Organization Tohoku University Graduate School of Medicine
Division name Department of Psychiatry
Zip code
Address 1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8574
TEL 022-717-7262
Homepage URL
Email kazuho-thk@umin.ac.jp

Sponsor
Institute Department of Psychiatry
Tohoku University Graduate School of Medicine
Institute
Department

Funding Source
Organization Miyagi Prefecture
Organization
Division
Category of Funding Organization Local Government
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 12 Month 14 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 Preinitiation
Date of protocol fixation
2012 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 01 Month 15 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
2016 Year 12 Month 14 Day
Last modified on
2018 Year 04 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027980

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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