UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000032393
Receipt number R000036947
Scientific Title Effect validation of Meta-cognitive training as a Transdiagnostic Approach
Date of disclosure of the study information 2018/04/26
Last modified on 2020/08/26 09:15:05

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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 or person

Institute

University of Miyazaki,Fuculty of Medicine,School of Nursing

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036947


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name