UMIN-CTR Clinical Trial

Basic information
Public title	Effect validation of Meta-cognitive training as a Transdiagnostic Approach
Acronym	Effect validation of Meta-cognitive training as a Transdiagnostic Approach
Scientific Title	Effect validation of Meta-cognitive training as a Transdiagnostic Approach
Scientific Title:Acronym	Effect validation of Meta-cognitive training as a Transdiagnostic Approach
Region	Japan

Condition
Condition	Mental disorders such as schizophrenia, mood disorder, anxiety disorder
Classification by specialty	Psychiatry Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Verify the effect of meta-cognitive training on QOL.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	EuroQol-5 dimensions-5 levels (EQ-5D-5L) (1)Pre MCT (2)Five weeks after the beginning of MCT (3)Post MCT (4)Four weeks follow-up
Key secondary outcomes	Cognitive Bias Questionnaire for psychosis(CBQp) The scores of positive symptoms in PANSS Global Assessment of Functioning(GAF) Beck Cognitive Insight Scale(BCIS) Beck Depression Inventory 2(BDI-2) Exploratory Outcomes: Self-Efficacy for Community Life Scale of Schizophrenia(SECL) Maladaptive and Adaptive Coping Styles Questionnaire(MAX) Rosenberg Self-esteem Scale(RSES) (1)Pre MCT (2)Five weeks after the beginning of MCT (3)Post MCT (4)Four weeks follow-up

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	Maneuver
Interventions/Control_1	Intervention group 1. MCT is practiced with the manual. 2. Subjects participate in ten modules of MCT in one hour group session a week. 3. The ten modules contain eight modules of Cycle A or B, and two additional modules. 4. Subjects answer the questionnaires and are estimated objectively by medical staff except the MCT practitioner at pre-MCT, after five modules, at post-MCT and four weeks follow-up.
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	Not applicable
Gender	Male and Female
Key inclusion criteria	(1) individuals who diagnosed with mental disorders (ICD-10) by psychiatrist (2) individuals who allowed to take part in this study by psychiatrist
Key exclusion criteria	(1) individuals who have scores above 5 in "hostility", or above 6 "suspicion" of PANSS
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Hiroki Middle name Last name Tanoue
Organization	University of Miyazaki
Division name	Fuculty of Medicine,School of Nursing
Zip code	8891692
Address	5200 kihara, kiyotake, Miyazaki
TEL	0985-85-9728
Email	hiroki_tanoue@med.miyazaki-u.ac.jp

Public contact
Name of contact person	1st name Hiroki Middle name Last name Tanoue
Organization	University of Miyazaki
Division name	Fuculty of Medicine,School of Nursing
Zip code	8891692
Address	5200 kihara, kiyotake, Miyazaki
TEL	0985-85-9728
Homepage URL
Email	hiroki_tanoue@med.miyazaki-u.ac.jp

Sponsor
Institute	University of Miyazaki,Fuculty of Medicine,School of Nursing
Institute
Department

Funding Source
Organization	Japan Society for the Promotion of Science
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	The Ethics Committee of University of Miyazaki
Address	5200 kihara, kiyotake, Miyazaki
Tel	0985-85-9010
Email	igakubu_kenkyu@med.miyazaki-u.ac.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	2018 Year 04 Month 26 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 07 Month 01 Day
Date of IRB	2018 Year 01 Month 17 Day
Anticipated trial start date	2018 Year 01 Month 17 Day
Last follow-up date	2019 Year 12 Month 31 Day
Date of closure to data entry	2020 Year 01 Month 31 Day
Date trial data considered complete	2020 Year 01 Month 31 Day
Date analysis concluded	2020 Year 02 Month 29 Day

Other
Other related information

Management information
Registered date	2018 Year 04 Month 26 Day
Last modified on	2020 Year 08 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036947