UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000029146
Receipt number R000033325
Scientific Title Feasibility study of Meta Cognitive Training for At-Risk Mental State in Japan
Date of disclosure of the study information 2017/12/01
Last modified on 2023/03/27 09:58:06

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Basic information

Public title

Feasibility study of Meta Cognitive Training for At-Risk Mental State in Japan

Acronym

Feasibility study of Meta Cognitive Training for At-Risk Mental State in Japan

Scientific Title

Feasibility study of Meta Cognitive Training for At-Risk Mental State in Japan

Scientific Title:Acronym

Feasibility study of Meta Cognitive Training for At-Risk Mental State in Japan

Region

Japan


Condition

Condition

At-Risk Mental State

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate feasibility of individualized Metacognitive Trainig for At-Risk Mental State

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Total Score of PANSS(Positive and Negative Syndrome Scale)

Key secondary outcomes

Positive Scale, Negative Scale, and General Psychopathology scale of PANSS(Positive and Negative Syndrome Scale)
Postive Symptom Scales of CAARMS (unusual thought content, non-bizarre ideas, perceptural abnormalities, disorganised speech)
BDI-II(Beck Depression Inventory)
CBQp(Cognitive Biases Questionnaire for Psychosis)
BAI(Beck Anxiety Inventory)
BCIS(Beck Cognitive Insight Scale)
BCSS(Brief Core Schema Scale)
GAF(The Global Assessment of Functioning)
SOFAS(Social and Occupational Functioning Assessment Scale)
Suicidality and self harm on CAARMS
Aggression/Dangerous Behaviour on CAARMS
CGIC(Clinical Global Impression of Change)
Japanese version of the Questionnare about the Process of Recovery


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

Treatment

Type of intervention

Behavior,custom

Interventions/Control_1

Individualized Metacognitive Training for At-Risk Mental State

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

14 years-old <=

Age-upper limit

35 years-old >=

Gender

Male and Female

Key inclusion criteria

A)meet ARMS criteria at the PACE clinic
B)age 14-35 years
C)impairment in social functioning before initiation of intervention
D)netive Japanese speaker
E)under treatment in Tohoku University Hospital
F)obtain written informed consent

Key exclusion criteria

A)use of antipsychotic medication during the past 1 month
B)severe learning impairment
C)problems due to an organic condition
D)have a previous history of Psychosis
E)Existing serious suicidal ideation or dangerous behavior
F)alcohol dependence or substance dependence
G)IQ below 70

Target sample size

15


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, Japan

TEL

022-717-7262

Email

kaz-mat@umin.net


Public contact

Name of contact person

1st name
Middle name
Last name Yumiko Hamaie

Organization

Tohoku University Hospital

Division name

Department of Psychiatry

Zip code


Address

1-1, Seiryo-machi, Aoba-ku, Sendai, Japan

TEL

022-717-7262

Homepage URL


Email

hama-ie72@umin.ac.jp


Sponsor or person

Institute

Department of Psychiatry, Tohoku University Graduate 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


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

2017 Year 12 Month 01 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

Completed

Date of protocol fixation

2017 Year 11 Month 01 Day

Date of IRB

2018 Year 08 Month 22 Day

Anticipated trial start date

2017 Year 11 Month 01 Day

Last follow-up date

2022 Year 12 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

2017 Year 09 Month 14 Day

Last modified on

2023 Year 03 Month 27 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033325


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name