UMIN-CTR Clinical Trial

Basic information
Public title	Pilot trial of Metacognitive Training
Acronym	Pilot trial of Metacognitive Training
Scientific Title	Pilot trial of Metacognitive Training
Scientific Title:Acronym	Pilot trial of Metacognitive Training
Region	Japan

Condition
Condition	Schizophrenia
Classification by specialty	Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The trial aims to investigate the effectiveness of the Japanese version of Metacognitive Training on metacogntion and reasoning bias in Japanese outpatients with schizophrenia.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase I

Assessment
Primary outcomes	a)Metacognition assessed by the Beck Cognitive Insight Scale b)Jumping to conclusion assessed by the beads task
Key secondary outcomes	a)change in distress caused by positive symptoms measured by the Psychotic Symptoms Rating Scale b)psychiatric symptom change measured by PANSS c)change in theory of mind assessed by WAIS-3 picture arrangement d)change in depression assessed by the Beck Depression Inventory 2

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Placebo
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Pseudo-randomization

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	Metacognitive Training weekly 60 min session for eight weeks
Interventions/Control_2	Treatment as usual
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	65 years-old >=
Gender	Male and Female
Key inclusion criteria	a) diagnosis of schizophrenia (DSM-4TR) b) age between 20 and 65. c) those who can understand the objective and procedure of the study and of free will give written consent. d) those who are users of psychiatric outpatient service
Key exclusion criteria	a) those with history of substance abuse within the past three months of the screening date b) those who are expected to be absent for more than 50% of the intervention. c) those with estimated premorbid IQ below 70 d) those who are expected to need change in medication during the intervention period due to unstable psychotic symptoms e) those assessed to be not fit for intervention by the psychiatrist in charge or the researcher
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Akiko Middle name Last name Kikuchi
Organization	National Institute of Mental Health, National Center of Neurology and Psychiatry
Division name	Department of Forensic Psychiatry
Zip code	187-8553
Address	4-1-1, Ogawa Higashi, Kodaira, Tokyo, Japan
TEL	042-341-2711
Email	akikuchi@ncnp.go.jp

Public contact
Name of contact person	1st name Akiko Middle name Last name Kikuchi
Organization	National Institute of Mental Health, National Center of Neurology and Psychiatry
Division name	Department of Forensic Psychiatry
Zip code	187-8553
Address	4-1-1, Ogawa Higashi, Kodaira, Tokyo, Japan
TEL	042-341-2711
Homepage URL
Email	akikuchi@ncnp.go.jp

Sponsor
Institute	National Institute of Mental Health, National Center of Neurology and Psychiatry
Institute
Department

Funding Source
Organization	Ministry of Health Labor and Welfare
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

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

IRB Contact (For public release)
Organization	National Center of Neurology and Psychiatry
Address	4-1-1 Ogawa Higashi, Kodaira, Tokyo, Japan
Tel	042-341-2711
Email	rinri-jimu@ncnp.go.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	2014 Year 07 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	No longer recruiting
Date of protocol fixation	2013 Year 09 Month 20 Day
Date of IRB
Anticipated trial start date	2013 Year 12 Month 01 Day
Last follow-up date	2015 Year 12 Month 28 Day
Date of closure to data entry	2016 Year 01 Month 30 Day
Date trial data considered complete	2016 Year 03 Month 10 Day
Date analysis concluded	2016 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date	2014 Year 07 Month 14 Day
Last modified on	2020 Year 01 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000016931