UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039965 |
|---|---|
| Receipt number | R000045564 |
| Scientific Title | Cognitive behavioral therapy for home-visit nursing users with psychosis: a pilot study |
| Date of disclosure of the study information | 2020/04/01 |
| Last modified on | 2022/09/27 09:06:17 |
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Basic information
Public title
Cognitive behavioral therapy for home-visit nursing users with psychosis: a pilot study
Acronym
Cognitive behavioral therapy for home-visit nursing users with psychosis: a pilot study
Scientific Title
Cognitive behavioral therapy for home-visit nursing users with psychosis: a pilot study
Scientific Title:Acronym
Cognitive behavioral therapy for home-visit nursing users with psychosis: a pilot study
Region
| Japan |
Condition
Condition
Schizophrenia
Classification by specialty
| Psychiatry | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, psychiatric visiting nursing staff (nurses and occupational therapists) who received training on LI-CBTp provided LI-CBTp to their users, which helped to reduce psychiatric symptoms and personal recovery. Conducting small-scale before-and-after trials to verify the impact confirmed the feasibility of large-scale intervention trials (RCTs) and revised points (study design, intervention criteria, sample size, Indicators, timing of intervention, etc.)
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Brief Psychiatric Rating Scale (BPRS)
The Japanese Version of the Questionnaire about the Process of Recovery (QPR-J)
The World Health Organization Disability Assessment Schedule (WHODAS2.0)
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
| Behavior,custom |
Interventions/Control_1
Cognitive behavioral technic for psychosis (Low-intensity CBT-p)
Period: About 6 months (12 times)
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
For users who meet all of the following criteria.
1. Those who have hallucinations and / or delusional symptoms (or both) and are diagnosed with mental illness and continue treatment
2. Persons who have contracted with a psychiatric nursing home provider and are regularly receiving psychiatric home nursing
3. Over 20 years old
4. A person who has obtained consent for this study by signing the consent form
Key exclusion criteria
Subjects who meet the following criteria will not be included in this study.
1. Those who cannot communicate in Japanese
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Yoshifumi |
| Middle name | |
| Last name | Kido |
Organization
Hamamatsu University School of Medicine
Division name
Faculty of Nursing
Zip code
431-3192
Address
1-20-1, Handayama, Higashi-ku, Hamamatsu-city
TEL
053-435-2823
ykido@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | Yoshifumi |
| Middle name | |
| Last name | Kido |
Organization
Hamamatsu University School of Medicine
Division name
Faculty of Nursing
Zip code
431-3192
Address
1-20-1, Handayama, Higashi-ku, Hamamatsu-city
TEL
053-435-2823
Homepage URL
ykido@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Nursing
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
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 University School of Medicine
Address
1-20-1, Handayama, Higashi-ku, Hamamatsu-city
Tel
053-435-2111
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
| 2020 | 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 | 01 | Month | 17 | Day |
Date of IRB
| 2020 | Year | 01 | Month | 22 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2022 | 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
| 2020 | Year | 03 | Month | 27 | Day |
Last modified on
| 2022 | Year | 09 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045564
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
