UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054690 |
|---|---|
| Receipt number | R000061593 |
| Scientific Title | Examination of Cognitive Function Improvement Therapy for Schizophrenia Patients Attending Psychiatric Day Care for Employment Transition |
| Date of disclosure of the study information | 2024/06/18 |
| Last modified on | 2024/06/18 12:37:43 |
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Basic information
Public title
Examination of Cognitive Function Improvement Therapy for Schizophrenia Patients Attending Psychiatric Day Care for Employment Transition
Acronym
Examination of Cognitive Function Improvement Therapy for Schizophrenia Patients Attending Psychiatric Day Care for Employment Transition
Scientific Title
Examination of Cognitive Function Improvement Therapy for Schizophrenia Patients Attending Psychiatric Day Care for Employment Transition
Scientific Title:Acronym
"Cognitive Improvement Therapy for Employment Transition in Schizophrenia Patients Attending Psychiatric Day Care Trial" (CITE-SchizoPDCT)
Region
| Japan |
Condition
Condition
schizophrenia
Classification by specialty
| Psychiatry | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Implementing Cognitive Remediation Therapy for Schizophrenia Patients Attending Psychiatric Day Care: Examining Pre- and Post-Intervention Effects and Exploring Factors Related to Transition to Employment
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
One week before the intervention, a cognitive function test is conducted, and within one week after the intervention, another cognitive function test is performed.
Key secondary outcomes
Age, gender, educational background, illness history, Japanese Adult Reading Test (JART), Positive and Negative Syndrome Scale (PANSS), divergent thinking tests (Idea Fluency Test, Design Fluency Test, and the modified Tinkertoy Test), Life Skills Profile
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Cognitive Remediation Therapy
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients diagnosed with schizophrenia attending psychiatric day care
Key exclusion criteria
Patients with a history of head trauma or brain injury
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yasuhisa |
| Middle name | |
| Last name | Nakamura |
Organization
Nihon Fukushi University
Division name
School of Health Sciences
Zip code
4750012
Address
26-2 Higashi-Ikemi-cho, Handa City, Aichi Prefecture
TEL
0569200131
n-yasu@n-fukushi.ac.jp
Public contact
Name of contact person
| 1st name | Yasuhisa |
| Middle name | |
| Last name | Nakamura |
Organization
Nihon Fukushi University
Division name
School of Health Sciences
Zip code
4750012
Address
26-2 Higashi-Ikemi-cho, Handa City, Aichi Prefecture
TEL
0569200131
Homepage URL
n-yasu@n-fukushi.ac.jp
Sponsor or person
Institute
Nihon Fukushi University
Institute
Department
Personal name
yasuhisa nakamura
Funding Source
Organization
Grants-in-Aid for Scientific Research
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
Kariya Hospital Ethics Committee
Address
2-30 Kandacho, Kariya City, Aichi Prefecture
Tel
0566-21-3511
n-yasu@n-fukushi.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 | 06 | Month | 18 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-bin/ctr/ctr_up_rec_f3.cgi
Publication of results
Unpublished
Result
URL related to results and publications
https://center6.umin.ac.jp/cgi-bin/ctr/ctr_up_rec_f5.cgi
Number of participants that the trial has enrolled
21
Results
A study was conducted on 21 patients with schizophrenia using the VCAT-J. Subsequently, the patients were divided into two groups: those who transitioned from psychiatric day care to employment support facilities within one year and those who did not. A comparison between these groups revealed a tendency for those who transitioned to have shown improvements in negative symptoms as measured by the VCAT-J.
Results date posted
| 2024 | Year | 06 | Month | 18 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The participants were patients diagnosed with schizophrenia, receiving outpatient treatment, and attending day care for more than three months. The study targeted individuals aged 20 years and older. Those with other comorbid conditions were excluded.
Participant flow
Participants were recruited by posting notices in the psychiatric day care center. Those who expressed interest and met the eligibility criteria were given an explanation of the study's outline and participated after providing written informed consent.
Adverse events
Adverse events may include the recurrence of psychiatric symptoms of schizophrenia or psychological burden. In such cases, participants were allowed to miss the program or withdraw their consent to continue the study if continuation became difficult.
Outcome measures
The evaluation items included basic information such as age, gender, illness history, educational background, and CPZ equivalent values. Psychiatric symptoms were assessed using GAF and PANSS. Cognitive function was measured using the Japanese versions of BACS, IFT, DFT, and m-TTT. Life skills were evaluated using LSP, with measurements taken before and after the intervention.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 01 | Month | 01 | Day |
Anticipated trial start date
| 2017 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2020 | 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
| 2024 | Year | 06 | Month | 18 | Day |
Last modified on
| 2024 | Year | 06 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061593
