UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061795 |
|---|---|
| Receipt number | R000070717 |
| Scientific Title | The effectiveness of the short-term intervention coping strategy enhancement (CSE) for people with schizophrenia who experience hallucinations and delusions in the community: A mixed-methods exploratory pilot study |
| Date of disclosure of the study information | 2026/06/04 |
| Last modified on | 2026/06/04 13:32:01 |
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Basic information
Public title
An examination of support strategies for coping with symptoms among community-dwelling individuals with Schizophrenia
Acronym
SSCS SCZ Study
Support Strategies for Coping with Symptoms in Schizophrenia
Scientific Title
The effectiveness of the short-term intervention coping strategy enhancement (CSE) for people with schizophrenia who experience hallucinations and delusions in the community: A mixed-methods exploratory pilot study
Scientific Title:Acronym
ST CSE SCZ
Short Term Coping Strategy Enhancement for Schizophrenia
Region
| Japan |
Condition
Condition
Schizophrenia
Classification by specialty
| Psychiatry | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to examine how the coping abilities of people with schizophrenia who experience chronic auditory hallucinations and delusions and live in the community change before and after four sessions of short-term coping strategy enhancement therapy conducted by visiting nurses, and to determine whether these changes are associated with changes in psychiatric symptoms and quality of life (QOL). Furthermore, based on the results of this study, we will examine whether enhancing symptom coping abilities may lead to improved quality of life and relapse prevention, and we will explore appropriate approaches to support for people with schizophrenia living in the community through home-visit nursing.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Evaluation limited to the seven BPRS items (hallucinations, impaired conceptual integration, suspiciousness, unusual thoughts, anxiety, guilt, and hostility).
2. Evaluation of the four areas of the WHOQOL-26 Japanese version (physical health: seven items, psychological health: six items, social relationships: three items, environment: eight items) and the two overall QOL items.
3. Interview-based qualitative evaluation of the effects of the short coping strategy enhancement method.
Key secondary outcomes
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
| Other |
Interventions/Control_1
The research implementer, who is a visiting nurse, will implement the short-term coping strategy enhancement method for five people with chronic schizophrenia and positive symptoms such as hallucinations and delusions in the community. The intervention period is scheduled from June to early October 2026.
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
Eligible participants must meet the following criteria:
1. Be enrolled in the Keayakinomori Hospital's Keayaki Home Care Station between June 1, 2026 and early Octover, 2026.
2. Have a diagnosis of chronic schizophrenia with stable symptoms.
3. Have permission from their primary care physician to participate in the study.
4. Have given their informed consent to participate in the study in writing.
5. Be between the ages of 18 and 65 at the time of consent.
Key exclusion criteria
The need for self-care and care for others is high, and the ability to understand and evaluate the severity of cognitive impairments is limited.
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | Yoshie |
| Middle name | |
| Last name | Okada |
Organization
International University of Health and Welfare
Division name
Department of Nursing, Narita College of Nursing
Zip code
286-8686
Address
4chome3 Kotsunomori Narita City Chiba Prefecture
TEL
0476-20-7720
yoshiok@ihwg.jp
Public contact
Name of contact person
| 1st name | Ai |
| Middle name | |
| Last name | Kajiya |
Organization
International University of Health and Welfare
Division name
Graduate School of Health and Welfare Sciences, Master's Program
Zip code
250-0045
Address
1-2-25 Shiroyama, Odawara City, Kanagawa Prefecture
TEL
090-4064-0494
Homepage URL
25S1039@g.iuhw.ac.jp
Sponsor or person
Institute
International University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
International University of Health and Welfare
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
International University of Health and Welfare
Address
250-0045 1-2-25 Shiroyama, Odawara City, Kanagawa Prefecture
Tel
0476-20-7720
yoshiok@ihwg.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
| 2026 | Year | 06 | Month | 04 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 06 | Month | 02 | Day |
Last follow-up date
| 2026 | Year | 10 | Month | 16 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 06 | Month | 04 | Day |
Last modified on
| 2026 | Year | 06 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070717
