UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054290 |
|---|---|
| Receipt number | R000062009 |
| Scientific Title | Cross-sectional research on the interrelationships between metacognition, effort-avoidance, and clinical symptoms in patients with schizophrenia |
| Date of disclosure of the study information | 2024/05/01 |
| Last modified on | 2025/05/02 10:36:22 |
* 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
Research on the relationship between behavioral characteristics and clinical evaluation in schizophrenia patients
Acronym
Research on behavior and clinical symptoms of schizophrenia patients
Scientific Title
Cross-sectional research on the interrelationships between metacognition, effort-avoidance, and clinical symptoms in patients with schizophrenia
Scientific Title:Acronym
Interrelationships between metacognition, effort-avoidance behavior, and clinical symptoms in patients with schizophrenia
Region
| Japan |
Condition
Condition
schizophrenia
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To quantitatively evaluate metacognitive ability and cognitive effort avoidance in patients with schizophrenia and clarify the relationship between these behavioral characteristics and clinical symptoms.
Basic objectives2
Others
Basic objectives -Others
Classification of schizophrenia patients and elucidation of behavioral pathology.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Parameters of behavioral tasks that measure metacognition and cognitive effort avoidance.
Metacognitive sensitivity
Metacognitive bias
Effort avoidance tendency
Key secondary outcomes
Clinical evaluation for schizophrenia.
Positive and Negative Syndrome Scale (PANSS)
Brief Positive Symptom Scale (BPRS)
Brief Negative Symptom Scale (BNSS)
Specific Levels of Functioning Scale (SLOF)
Montreal Cognitive Assessment (MoCA-J)
The Brief Assessment of Cognition in Schizophrenia (BACS-J)
Beck Depression Inventory (BDI)
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Those who have been diagnosed with schizophrenia.
Those who have been discharged from hospital for at least 2 months and whose symptoms and medication status are stable.
Key exclusion criteria
Those whose symptoms and medication status are not stable.
Difficulty completing behavioral tasks due to severe psychiatric symptoms or decline in cognitive function.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Kazuki |
| Middle name | |
| Last name | Yoshida |
Organization
Hokkaido University
Division name
Faculty of Health Sciences
Zip code
060-0812
Address
Kita 12, Nishi 5, Kita-ku, Sapporo
TEL
0117063414
ot-k-yoshida@huhp.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Kazuki |
| Middle name | |
| Last name | Yoshida |
Organization
Hokkaido University
Division name
Faculty of Health Sciences
Zip code
060-0812
Address
Kita 12, Nishi 5, Kita-ku, Sapporo
TEL
0117063414
Homepage URL
ot-k-yoshida@huhp.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University
Institute
Department
Personal name
Yoshida Kazuki
Funding Source
Organization
Japan Society for the Promotion of Science, Grants-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of the Faculty of Health Sciences, Hokkaido University
Address
Nishi 5, Kita 12, Kita-ku, Sapporo, Hokkaido
Tel
011-706-3316
shomu@hs.hokudai.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
| 2024 | Year | 05 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 01 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A cross-sectional study will examine the interaction between metacognition, cognitive effort avoidance behaviors, and clinical assessment in patients with schizophrenia.
Management information
Registered date
| 2024 | Year | 05 | Month | 01 | Day |
Last modified on
| 2025 | Year | 05 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062009
