UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
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 2018/12/07

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Middle name
Last name Takuma Ishigaki
Organization the University of Tokyo
Division name Graduate School of Arts and Sciences
Zip code
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
Middle name
Last name Takuma Ishigaki
Organization the University of Tokyo
Division name Graduate School of Arts and Sciences
Zip code
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
Address
Tel
Email

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
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 No longer recruiting
Date of protocol fixation
2017 Year 03 Month 31 Day
Date of IRB
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
2018 Year 12 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


Contact us.