| 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 (Ver. 12) |
| 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 |
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| Condition | ||
| Condition | schizophrenia | |
| Classification by specialty |
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| 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 |
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| 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. |
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| 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. |
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| 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 |
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| Age-upper limit |
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| 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 |
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| 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 |
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| Target sample size | 50 | |||
| Research contact person | |||||||
| Name of lead principal investigator |
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| 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 | ||||||
| cisigaki@mail.ecc.u-tokyo.ac.jp | |||||||
| Public contact | |||||||
| Name of contact person |
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| 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 | |||||||
| 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 |
| 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 |
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| 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. |
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| Results date posted |
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| 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. |
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| 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). |
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| Adverse events | nothing |
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| Outcome measures | PANSS GAF CBQp BCIS BDI-2 EQ-5D-5L Rosenberg Self-esteem Scale |
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| Plan to share IPD | |||||||
| IPD sharing Plan description | |||||||
| Progress | |||||||
| Recruitment status | Main results already published | ||||||
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| Date trial data considered complete |
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| Date analysis concluded |
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| Link to view the page | |
| URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031283 |