UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000027301
Receipt number R000031283
Scientific Title Randomized Controlled Trial of Metacognitive Training: a Clinical Psychological Investigation
Date of disclosure of the study information 2017/05/15
Last modified on 2019/11/07 14:38:54

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Basic information

Public title

Randomized Controlled Trial of Metacognitive Training: a Clinical Psychological Investigation

Acronym

Randomized Controlled Trial of Metacognitive Training: a Clinical Psychological Investigation

Scientific Title

Randomized Controlled Trial of Metacognitive Training: a Clinical Psychological Investigation

Scientific Title:Acronym

Randomized Controlled Trial of Metacognitive Training: a Clinical Psychological Investigation

Region

Japan


Condition

Condition

schizophrenia

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examine the efficacy of Metacognitive Training (MCT) for the biased cognition related with delusion of schizophrenia

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

The scores of positive symptoms in PANSS
(1)Pre MCT
(2)Five weeks after the beginning of MCT
(3)Post MCT
(4)Four weeks follow-up

Key secondary outcomes

Global Assessment of Functioning(GAF), Cognitive Bias Questionnaire for psychosis(CBQp), Beck Cognitive Insight Scale(BCIS), Self-Efficacy for Community Life Scale of Schizophrenia(SECL), Maladaptive and Adaptive Coping Styles Questionnaire(MAX), EQ-5D-5L, Beck Depression Inventory 2(BDI-2), 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

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

Active

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is considered as adjustment factor in dynamic allocation.

Blocking

NO

Concealment

Central registration


Intervention

No. of arms

2

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

Control group
1. Subjects continue to receive usual medical care.
2. Subjects answer the questionnaires and are estimated objectively by medical staff except the MCT practitioner at pre-waiting, after five, ten and fourteen weeks.

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

60 years-old >=

Gender

Male and Female

Key inclusion criteria

people
(1)diagnosed with schizophrenia(ICD-10) by psychiatrist
(2)correspond to "psychotic disorder" in M.I.N.I.
(3)allowed to take part in this research by psychiatrist
(4)score above 2 in "delusion" of PANSS

Key exclusion criteria

people
(1)with intellectual disorder, developmental disorder, organic brain dysfunction and substance abuse
(2)score above 5 in "hostility", or above 6 "suspicion" of PANSS

Target sample size

50


Research contact person

Name of lead principal investigator

1st name Takuma
Middle name
Last name Ishigaki

Organization

The University of Tokyo

Division name

Graduate School of Arts and Sciences

Zip code

153-8902

Address

3-8-1 Komaba, Meguro-ku, Tokyo

TEL

03-5454-4438

Email

cisigaki@mail.ecc.u-tokyo.ac.jp


Public contact

Name of contact person

1st name Takuma
Middle name
Last name Ishigaki

Organization

The University of Tokyo

Division name

Graduate School of Arts and Sciences

Zip code

153-8902

Address

3-8-1 Komaba, Meguro-ku, Tokyo

TEL

03-5454-4438

Homepage URL


Email

cisigaki@mail.ecc.u-tokyo.ac.jp


Sponsor or person

Institute

the University of Tokyo, Graduate School of Arts and Sciences

Institute

Department

Personal name



Funding Source

Organization

Japan Society for the Promotion of Science

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Ethics Review Committee on Experimental Research with Human Subjects

Address

3-8-1 Komaba, Meguro-ku, Tokyo

Tel

03-5454-7617

Email

ken9@adm.c.u-tokyo.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

肥前精神医療センター(佐賀県)、大内病院(東京都)、メンタルサポートそよかぜ病院(長野県)、若草病院(宮崎県)、谷口病院(宮崎県)、札幌花園病院(北海道)


Other administrative information

Date of disclosure of the study information

2017 Year 05 Month 15 Day


Related information

URL releasing protocol

https://www.sciencedirect.com/journal/schizophrenia-research/articles-in-press?page=4

Publication of results

Published


Result

URL related to results and publications

https://www.sciencedirect.com/journal/schizophrenia-research/articles-in-press?page=4

Number of participants that the trial has enrolled

50

Results

The primary outcome was positive symptom score, as measured by PANSS. GAF and measures of cognitive biases were secondary outcomes. The severity of PANSS positive symptoms declined significantly in the TAU?+?MCT treatment group compared with the TAU group. GAF also showed significantly greater improvement in the TAU?+?MCT group compared with the TAU group. There was also a trend for greater efficacy of MCT on cognitive biases.

Results date posted

2019 Year 11 Month 07 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

1. The people fulfilled criteria for a schizophrenia, schizotypal and delusional disorders according to ICD-10 (F20-F29).
2. They were 20-60 years old, male and female
3. The people fulfilled of criteria for a schizophrenia spectrum disorder according to the Mini-International Neuropsychiatric Interview (M.I.N.I.)
4. A minimal symptom threshold was defined for inclusion criteria: above 3 on the delusion component of the PANSS.
5. Exclusion criteria were patients who had an intellectual disability, developmental disorder, dementia deficiency, personality disorder, organic brain damage, or history of substance abuse.
6. People who scored above 5 on the PANSS hostility item, or who scored above 6 on the suspiciousness item were excluded.

Participant flow

1. 78 people who fulfilled the criteria of ICD-10 were recruited.
2. 13 people were estimated below 2 points in delusion of PANSS.
3. Ages of 6 people failed to fulfill the condition.
4. 5 people failed to fulfill the condition of M.I.N.I.
5. 1 people was estimated above 5 points in hostility of PANSS.
6. 3 in 53 people who fulfilled all of the conditions declined to participate in this research.
7. 50 people were randomly divided into MCT+TAU group (n=24) and TAU group (n=26).

Adverse events

nothing

Outcome measures

PANSS
GAF
CBQp
BCIS
BDI-2
EQ-5D-5L
Rosenberg Self-esteem Scale

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Main results already published

Date of protocol fixation

2017 Year 03 Month 31 Day

Date of IRB

2017 Year 02 Month 23 Day

Anticipated trial start date

2017 Year 06 Month 01 Day

Last follow-up date

2018 Year 08 Month 07 Day

Date of closure to data entry

2018 Year 08 Month 07 Day

Date trial data considered complete

2018 Year 08 Month 31 Day

Date analysis concluded

2018 Year 10 Month 31 Day


Other

Other related information



Management information

Registered date

2017 Year 05 Month 10 Day

Last modified on

2019 Year 11 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031283


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name