UMIN-CTR Clinical Trial

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
Email	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
Email	ykido@hama-med.ac.jp

Sponsor
Institute	Hamamatsu University School of Nursing
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045564