UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043807 |
|---|---|
| Receipt number | R000050009 |
| Scientific Title | Effectiveness Study of Individual Metacognitive Training in Psychiatric Home Visit Nursing: A prospective, single-group study. |
| Date of disclosure of the study information | 2021/04/01 |
| Last modified on | 2023/12/01 13:01:05 |
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Basic information
Public title
Effectiveness Study of Individual Metacognitive Training in Psychiatric Home Visit Nursing: A prospective, single-group study.
Acronym
individual Metacognitive training in psychiatric home visit nursing.
Scientific Title
Effectiveness Study of Individual Metacognitive Training in Psychiatric Home Visit Nursing: A prospective, single-group study.
Scientific Title:Acronym
individual Metacognitive training in psychiatric home visit nursing.
Region
| Japan |
Condition
Condition
Schizophrenia
Classification by specialty
| Psychiatry | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine effectiveness of individual metacognitive training conducted in a psychiatric home visit nursing service.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Positive and Negative Syndrome Scale (PANSS)
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)
EuroQOL 5 dimensions 5-level(EQ-5D-5L)
Beck Depression Inventory 2(BDI-II)
Rosenberg Self-esteem Scale(RSES)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Individual Metacognitive training (MCT+)
A total of 11 sessions (once every one or two weeks)
Interventions/Control_2
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Primary diagnosis of schizophrenia
Key exclusion criteria
Individuals who have scores above 5 in "hostility", or above 6 "suspicion" of PANSS
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Hiroki |
| Middle name | |
| Last name | Tanoue |
Organization
University of Miyazaki
Division name
Faculty of Medicine, School of Nursing
Zip code
8891692
Address
5200 kihara, kiyotake, Miyazaki
TEL
0985-85-9728
hiroki_tanoue@med.miyazaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroki |
| Middle name | |
| Last name | Tanoue |
Organization
University of Miyazaki
Division name
Faculty of Medicine, School of Nursing
Zip code
8891692
Address
5200 kihara, kiyotake, Miyazaki
TEL
0985-85-9728
Homepage URL
hiroki_tanoue@med.miyazaki-u.ac.jp
Sponsor or person
Institute
University of Miyazaki, Faculty of Medicine, School of Nursing
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethics Committee of University of Miyazaki
Address
5200 kihara, kiyotake, Miyazaki
Tel
0985-85-9010
rinken@med.miyazaki-u.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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 04 | Month | 01 | 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
Completed
Date of protocol fixation
| 2020 | Year | 11 | Month | 12 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 12 | Day |
Anticipated trial start date
| 2020 | Year | 11 | Month | 12 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 04 | Month | 01 | Day |
Last modified on
| 2023 | Year | 12 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050009
