UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000048086 |
|---|---|
| Receipt number | 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 14:47:26 |
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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
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
kfumi@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000054800
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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