UMIN-CTR Clinical Trial

Basic information
Public title	Effectiveness of metacognitive training for schizophrenic patients: Randomized controlled trial
Acronym	Metacognitive training for schizophrenic patients
Scientific Title	Effectiveness of metacognitive training for schizophrenic patients: Randomized controlled trial
Scientific Title:Acronym	Metacognitive training for schizophrenic patients
Region	Japan

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

Objectives
Narrative objectives1	Verify the effect of metacognitive training on schizophrenic patients
Basic objectives2	Others
Basic objectives -Others	Search for factors predicting recurrence (re-hospitalization) one year after discharge.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Score change of The Brief Assessment of Cognition in Schizophrenia 3 months after treatment start or discharge
Key secondary outcomes	Score change of Positive and Negative Syndrome Scale 3 months after treatment start or discharge

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Placebo
Stratification	YES
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Other
Interventions/Control_1	During the hospital stay for a few months, metacognitive training (MCT) will be conducted twice a week, 16 times in total, in addition to usual occupational therapy.
Interventions/Control_2	A usual occupational therapy will be carried out during the hospitalization period of a few months.
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	1) Person who is in hospital in psychiatric hospital. 2) Persons diagnosed with schizophrenia or schizophrenia affective disorder. 3) Person who prescribed occupational therapy from the attending physician. 4) After receiving sufficient explanation for the participation of this research, those who gained written consent based on the free will of the patient himself / herself.
Key exclusion criteria	1) Person who is under 20 years old or over 65 years old. 2) Persons who have mergers such as intellectual disability, alcohol / drug dependence (substance abuse / dependence), dementia, epilepsy, head trauma, cerebrovascular disease etc. 3) Persons who are unstable in medical condition and have difficulty performing MCT or cognitive function test. 4) Persons who have not received occupational therapy. 5) Persons who can not obtain consent to participate in research. 6) Person who judged that the doctor or research director is ineligible.
Target sample size	46

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

Public contact
Name of contact person	1st name Masayoshi Middle name Last name Kobayashi
Organization	Shinshu University Graduate School of Health Science
Division name	Division of Occupational Therapy
Zip code	390-8621
Address	Matsumoto
TEL	0263372403
Homepage URL
Email	mkobaya@shinshu-u.ac.jp

Sponsor
Institute	Tikumaso Mental Hospital
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	Shinshu University Graduate School of Medicine
Address	3-1-1
Tel	0263372403
Email	mkobaya@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

Other administrative information
Date of disclosure of the study information	2021 Year 06 Month 30 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	24
Results	Post evaluation showed significant improvement in BACS Verbal fluency, Executive function, and Composite score, but two-way ANOVA did not show any interaction. In PANSS, positive and negative symptoms were significantly reduced, and time x group interaction was observed in general pathology. In BCIS, self-reflection in the OT + IMI group tended to improve, but there was no difference between the groups and the interaction was small.
Results date posted	2021 Year 02 Month 10 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	Among schizophrenia patients admitted to the psychiatric emergency ward, those who received occupational therapy.The age (M (SD)) of the participants was 44.25 (8.58) years in the OT + MCT group and 43.25 (7.98) years in the OT alone group.
Participant flow	Patients who meet the criteria, n=24. Random allocation: OT+MCT group, n=12 OT alone group, n=12 4 members of the OT+MCT group were discharged during the follow-up period. 2 of the OT alone groups were discharged and another two withdrew their consent.
Adverse events	None
Outcome measures	The Brief Assessment of Cognition in Schizophrenia (BACS) Positive and Negative Syndrome Scale (PANSS) Beck Cognitive Insight Scale (BCIS) Intrinsic Motivation Inventory (IMI) Client Satisfaction Questionnaire (CSQ)
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 09 Month 04 Day
Date of IRB	2018 Year 09 Month 04 Day
Anticipated trial start date	2018 Year 09 Month 10 Day
Last follow-up date	2020 Year 12 Month 31 Day
Date of closure to data entry	2020 Year 12 Month 31 Day
Date trial data considered complete	2020 Year 12 Month 31 Day
Date analysis concluded	2021 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date	2018 Year 09 Month 12 Day
Last modified on	2021 Year 02 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000038868