UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056608 |
|---|---|
| Receipt number | R000064536 |
| Scientific Title | Effectiveness of cognitive behavioral techniques for psychosis used in outpatient nursing counseling room: a randomized controlled trial |
| Date of disclosure of the study information | 2024/12/31 |
| Last modified on | 2025/01/31 14:45:03 |
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Basic information
Public title
Effectiveness of cognitive behavioral techniques for psychosis used in outpatient nursing counseling room: a randomized controlled trial
Acronym
Effectiveness of cognitive behavioral techniques for psychosis used in outpatient nursing counseling room: a randomized controlled trial
Scientific Title
Effectiveness of cognitive behavioral techniques for psychosis used in outpatient nursing counseling room: a randomized controlled trial
Scientific Title:Acronym
Effectiveness of cognitive behavioral techniques for psychosis used in outpatient nursing counseling room: a randomized controlled trial
Region
| Japan |
Condition
Condition
schizophrenia
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine whether using cognitive-behavioral techniques for psychosis in outpatient nursing counseling room care is more effective in improving psychiatric symptoms, general functioning, and illness awareness compared to regular outpatient nursing care.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Both intervention and control groups will undergo a pre-intervention evaluation.Next, a post-intervention evaluation will be conducted after a total of 10 sessions, and a follow-up evaluation will be conducted 3 months after the end of the intervention.The primary endpoint will be change in psychiatric symptoms as measured by the PANSS.
Key secondary outcomes
Global Assessment of Functioning (GAF), disease awareness (SAI-J), recovery (RAS), and hospitalization.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
[Outpatient nursing counseling room using cognitive-behavioral techniques]
A total of 10 sessions will be offered.The intervention will be based on the Cognitive Behavioral Techniques for Hallucination and Delusion Symptoms: a Guide for Mental Health Supporters (NEOMED BeST, 2019).The flow of the sessions is as follows
1-2: Build rapport and cooperation.
3rd-5th: Develop a shared understanding of the patient's symptoms and problems.
6th-9th: Aim to acquire new coping behaviors.
10: Review relapse prevention plan to maintain symptoms and prevent relapse.
Each session will include an understanding of symptoms, normalization, stress vulnerability model, and introduction to coping techniques based on the cognitive model, which will be reviewed with the patient and nurse together.Feedback is provided after each session, and homework is set to be worked on before the next meeting.The home work is recorded using an application and used in sessions and in real life.
Interventions/Control_2
[TAU: normal outpatient nursing]
The 10 sessions consist of supportive interventions that focus on listening and empathy, organizing problems, and referring to resources for support.
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1 Schizophrenia
ICD10: F2 Schizophrenia, schizotypal disorder and delusional disorder
DSM5TR:schizophrenia spectrum disorder and other psychiatric disorders
2 those with persistent positive symptoms (hallucinations and delusions)
3 those deemed necessary by a physician
4 those who have signed a consent form for participation in this study
5 18years of age or olde
Key exclusion criteria
1. Has intellectual disability.(If the patient is considered to have an IQ of about 70 or less based on the attending physician's overall judgment)
2. Has a substance-induced psychotic disorder or organic mental disorder.
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Yoshifumi |
| Middle name | |
| Last name | Kido |
Organization
Hamamatsu University School of Medicine
Division name
Department of Nursing, Faculty of Medicine
Zip code
431-3192
Address
Department of Nursing, Faculty of Medicine
TEL
0534352111
ykido@hama-med.ad.jp
Public contact
Name of contact person
| 1st name | Yoshifumi |
| Middle name | |
| Last name | Kido |
Organization
Hamamatsu University School of Medicine
Division name
Department of Nursing, Faculty of Medicine
Zip code
431-3192
Address
Department of Nursing, Faculty of Medicine
TEL
053-435-2823
Homepage URL
ykido@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine
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
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hamamatsu Medical University, Department of Life Sciences and Medicine, Research Ethics Committee
Address
1-20-1 Handayama, Chuo-ku, Hamamatsu City, Shizuoka Prefecture
Tel
053-435-2823
rinri@hama-med.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 | 12 | Month | 31 | 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 | 12 | Month | 13 | Day |
Date of IRB
| 2024 | Year | 12 | Month | 13 | Day |
Anticipated trial start date
| 2025 | Year | 01 | Month | 05 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 01 | 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 | 12 | Month | 30 | Day |
Last modified on
| 2025 | Year | 01 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064536
