UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000044956
Receipt number R000051349
Scientific Title Efficacy of metacognitive training for long-term hospitalized patients with schizophrenia
Date of disclosure of the study information 2021/07/27
Last modified on 2021/07/26 13:00:40

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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 or person

Institute

Shinshu University

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051349


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name