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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000048086
Receipt No. R000054800
Scientific Title Psychosocial effects of an individual occupational therapy using life review and collage book making for long-term hospitalized patients with schizophrenia.
Date of disclosure of the study information 2022/06/17
Last modified on 2022/06/17

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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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