UMIN-CTR Clinical Trial

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

a psychotic disorder or a mood disorder with psychotic features

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

NO

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

Primary outcomes

reliabirity and validity of TSQ Japanese version

Key secondary outcomes

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Department of Psychiatry
Tohoku University Graduate School of Medicine

Institute

Department

Personal name

Organization

Miyagi Prefecture

Organization

Division

Category of Funding Organization

Local Government

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2016

Year

12

Month

14

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2016

Year

12

Month

14

Day

Last modified on

2018

Year

04

Month

11

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027980