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Recruitment status Main results already published
Unique ID issued by UMIN UMIN000027301
Receipt No. 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

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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
Institute the University of Tokyo, Graduate School of Arts and Sciences
Institute
Department

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
URL(English) https://upload.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


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