UMIN-CTR Clinical Trial

Basic information
Public title	Efficacy of metacognitive training for long-term hospitalized patients with schizophrenia
Acronym	Efficacy of metacognitive training for long-term hospitalized patients with schizophrenia
Scientific Title	Efficacy of metacognitive training for long-term hospitalized patients with schizophrenia
Scientific Title:Acronym	Efficacy of metacognitive training for long-term hospitalized patients with schizophrenia
Region	Japan

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

Objectives
Narrative objectives1	To investigate the effectiveness of metacognitive training (MCT) in long-term hospitalized patients with schizophrenia by comparing it with the usual care group.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Japanese version of Montreal Cognitive Assessment (MoCA-J)
Key secondary outcomes	Positive and Negative Syndrome Scale (PANSS) Beck Cognitive Insight Scale (BCIS-J) Global Assessment of Functioning (GAF)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	MCT will be introduced once a week in addition to regular occupational therapy for a total of 16 sessions. The target group will receive regular occupational therapy.
Interventions/Control_2	Assign two groups: intervention group and target group.
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	80 years-old >
Gender	Male and Female
Key inclusion criteria	1) Patients who have been hospitalized at Uematsu Hospital for more than one year (2) Patients with a diagnosis of schizophrenia (3) Patients undergoing occupational therapy (4) Patients who have given written consent to participate in this study based on their own free will after receiving sufficient explanation.
Key exclusion criteria	1) Patients under 20 years old. 2) Intellectual disability. Patients with complications such as alcohol or drug dependence, dementia, epilepsy, head trauma, cerebrovascular disease, etc. 3) Patients who have difficulty in performing MCT. 4) Patients who are not receiving occupational therapy. (5) Patients who cannot give consent to participate in the study 6) Patients who are judged ineligible by the attending physician or principal investigator
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Masayoshi Middle name Last name Kobayashi
Organization	Shinshu University
Division name	Graduate School of General Medical Science and Engineering
Zip code	390-8621
Address	Nagano,Matsumoto,asahi 3-1-1
TEL	0263372403
Email	mkobaya@shinshu-u.ac.jp

Public contact
Name of contact person	1st name Rumi Middle name Last name Sunohara
Organization	NAGANO UNIVERSITY OF HEALTH AND MEDICINE
Division name	Department of Rehabilitation, Faculty of Health Sciences
Zip code	380
Address	Nagano,Nagano.Kawanakajima-machi,Imaihara11-1
TEL	026-283-6111
Homepage URL
Email	sunohara.rumi@shitoku.ac.jp

Sponsor
Institute	Shinshu University
Institute
Department

Funding Source
Organization	Shinshu University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Ethics Committee ,Shinshu University School of Medicine
Address	Nagano,Matsumoto,Asahi 3-1-1
Tel	0263-37-2572
Email	mdrinri@shinshu-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	上松病院（長野県）

Other administrative information
Date of disclosure of the study information	2021 Year 07 Month 27 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	Preinitiation
Date of protocol fixation	2021 Year 06 Month 10 Day
Date of IRB	2021 Year 06 Month 11 Day
Anticipated trial start date	2021 Year 08 Month 17 Day
Last follow-up date	2022 Year 08 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	2021 Year 07 Month 26 Day
Last modified on	2021 Year 07 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051349