UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Reliability and validity of TSQ Japanese version in patients with psychotic disorders
Title of the study (Brief title)	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	Kazunori Matsumoto
Organization	Tohoku University Graduate School of Medicine
Division name	Department of Psychiatry
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	Kazuho Tomimoto
Organization	Tohoku University Graduate School of Medicine
Division name	Department of Psychiatry
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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2012 Year 12 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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