UMIN-CTR Clinical Trial

Basic information
Public title	Psychosocial effects of an individual occupational therapy using life review and collage book making for long-term hospitalized patients with schizophrenia.
Acronym	Psychosocial effects of life review and collage book making for long-term hospitalized patients with schizophrenia.
Scientific Title	Psychosocial effects of an individual occupational therapy using life review and collage book making for long-term hospitalized patients with schizophrenia.
Scientific Title:Acronym	Psychosocial effects of life review and collage book making for long-term hospitalized patients with schizophrenia.
Region	Japan

Condition
Condition	schizophrenia
Classification by specialty	Psychiatry Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the psychosocial effects of a life review-based collage book making program as an individual occupational therapy for long-term hospitalized patients with schizophrenia.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Psychological aspects are assessed using the Profile of Mood States (POMS) Brief Form and the Recovery Assessment Scale (RAS), and social functions are assessed using the Life Skills Profile (LSP). Assessments are conducted at three time points: pre-intervention, post-intervention, and 3 months after the end of the intervention.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	In addition to the occupational therapy programs already attending, each participant receives a life review-based collage book making program as an individual occupational therapy session of approximately 60 minutes once a week for 6 weeks.
Interventions/Control_2	Each participant continues only the occupational therapy programs they are already receiving.
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	1. diagnosed by a psychiatrist as Schizophrenia 2. hospitalized in a psychiatric hospital for more than 1 year 3.verbal communication is possible 4.judged by the psychiatrist in charge of the patient to be psychiatrically stable and able to participate in the study 5.The participants must have been informed of and fully understood the study and have given their own written consent to participate in the study.
Key exclusion criteria	1.significant lack of awareness of illness 2.incapable of understanding the content of questionnaires or instructions.
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Hitoshi Middle name Last name Okamura
Organization	Hiroshima University
Division name	Graduate School of Biomedical and Health Sciences
Zip code	734-8551
Address	1-2-3, Kasumi, Minami-ku, Hiroshima, JAPAN
TEL	082-257-5450
Email	hokamura@hiroshima-u.ac.jp

Public contact
Name of contact person	1st name Fumiko Middle name Last name Kaneko
Organization	Hiroshima University
Division name	Graduate School of Biomedical and Health Sciences
Zip code	734-8551
Address	1-2-3, Kasumi, Minami-ku, Hiroshima, JAPAN
TEL	082-257-5451
Homepage URL
Email	kfumi@hiroshima-u.ac.jp

Sponsor
Institute	Hiroshima University
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Ethical Committee of Graduate School of Biomedical and Health Sciences, Hiroshima University
Address	1-2-3, Kasumi, Minami-ku, Hiroshima, JAPAN
Tel	082-257-5400
Email	hhanaoka@hiroshima-u.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	2022 Year 06 Month 17 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	51
Results
Results date posted
Results Delayed	Delay expected
Results Delay Reason	Now, we are working to publish.
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	2013 Year 05 Month 01 Day
Date of IRB	2013 Year 05 Month 01 Day
Anticipated trial start date	2013 Year 05 Month 24 Day
Last follow-up date	2018 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	2022 Year 06 Month 17 Day
Last modified on	2022 Year 06 Month 17 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054800

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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