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 |
Randomized Controlled Trial of Metacognitive Training: a Clinical Psychological Investigation
Randomized Controlled Trial of Metacognitive Training: a Clinical Psychological Investigation
Randomized Controlled Trial of Metacognitive Training: a Clinical Psychological Investigation
Randomized Controlled Trial of Metacognitive Training: a Clinical Psychological Investigation
Japan |
schizophrenia
Psychiatry |
Others
NO
To examine the efficacy of Metacognitive Training (MCT) for the biased cognition related with delusion of schizophrenia
Safety,Efficacy
Exploratory
Pragmatic
Not applicable
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
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
Interventional
Parallel
Randomized
Individual
Open -but assessor(s) are blinded
Active
YES
YES
Institution is considered as adjustment factor in dynamic allocation.
NO
Central registration
2
Treatment
Maneuver |
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.
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.
20 | years-old | <= |
60 | years-old | >= |
Male and Female
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
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
50
1st name | Takuma |
Middle name | |
Last name | Ishigaki |
The University of Tokyo
Graduate School of Arts and Sciences
153-8902
3-8-1 Komaba, Meguro-ku, Tokyo
03-5454-4438
cisigaki@mail.ecc.u-tokyo.ac.jp
1st name | Takuma |
Middle name | |
Last name | Ishigaki |
The University of Tokyo
Graduate School of Arts and Sciences
153-8902
3-8-1 Komaba, Meguro-ku, Tokyo
03-5454-4438
cisigaki@mail.ecc.u-tokyo.ac.jp
the University of Tokyo, Graduate School of Arts and Sciences
Japan Society for the Promotion of Science
Other
Japan
Ethics Review Committee on Experimental Research with Human Subjects
3-8-1 Komaba, Meguro-ku, Tokyo
03-5454-7617
ken9@adm.c.u-tokyo.ac.jp
NO
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)
2017 | Year | 05 | Month | 15 | Day |
https://www.sciencedirect.com/journal/schizophrenia-research/articles-in-press?page=4
Published
https://www.sciencedirect.com/journal/schizophrenia-research/articles-in-press?page=4
50
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.
2019 | Year | 11 | Month | 07 | Day |
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.
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).
nothing
PANSS
GAF
CBQp
BCIS
BDI-2
EQ-5D-5L
Rosenberg Self-esteem Scale
Main results already published
2017 | Year | 03 | Month | 31 | Day |
2017 | Year | 02 | Month | 23 | Day |
2017 | Year | 06 | Month | 01 | Day |
2018 | Year | 08 | Month | 07 | Day |
2018 | Year | 08 | Month | 07 | Day |
2018 | Year | 08 | Month | 31 | Day |
2018 | Year | 10 | Month | 31 | Day |
2017 | Year | 05 | Month | 10 | Day |
2019 | Year | 11 | Month | 07 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031283
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