UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057271 |
|---|---|
| Receipt number | R000057383 |
| Scientific Title | Evaluation of the effectiveness of an early occupational therapy program to promote motivation for occupation among Inpatients in a psychiatric hospital:A mixed methods study |
| Date of disclosure of the study information | 2025/03/12 |
| Last modified on | 2025/09/13 19:52:40 |
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Basic information
Public title
Evaluation of the effectiveness of an early occupational therapy program to promote motivation for occupation among Inpatients in a psychiatric hospital:A mixed methods study
Acronym
Evaluation of the effectiveness of an early occupational therapy program to promote motivation for occupation:A mixed methods study
Scientific Title
Evaluation of the effectiveness of an early occupational therapy program to promote motivation for occupation among Inpatients in a psychiatric hospital:A mixed methods study
Scientific Title:Acronym
Evaluation of the effectiveness of an early occupational therapy program to promote motivation for occupation:A mixed methods study
Region
| Japan |
Condition
Condition
Mental disorders
Classification by specialty
| Psychiatry | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effectiveness of an early group occupational therapy program for psychiatric inpatients using a mixed research method based on a convergent design.
Basic objectives2
Others
Basic objectives -Others
To evaluate the change in intrinsic motivation, self-recognition about occupation, patterns of occupation, self-efficacy, and social functioning
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Intrinsic Motivation Inventory(short-term outcome)
Occupational Self Assessment Short Form(long-term outome)
Key secondary outcomes
Occupational Self Assessment Short Form
Intrinsic Motivation Inventory
Occupational Questionnaire
General Self Efficacy Scale
Life Assessment Scale for the Mentally Ill
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
To give knowledge about occupation and health.
Set and implement goals for participant occupation and health
Interventions/Control_2
To give only standard occupational therapy
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
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Mentally ill patients who have been hospitalized in a psychiatric hospital for less than 3 months
Key exclusion criteria
Those who find it difficult to participate in the 90~120 minute program
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | SASAKI |
Organization
Ibaraki Prefectural University of Health Sciences
Division name
Department of Occupational Therapy
Zip code
300-0394
Address
4669-2 Ami, Ami-machi, Inashiki-gun, Ibaraki
TEL
029-840-2220
ssakita@ipu.ac.jp
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | SASAKI |
Organization
Ibaraki Prefectural University of Health Sciences
Division name
Department of Occupational Therapy
Zip code
300-0394
Address
4669-2 Ami, Ami-machi, Inashiki-gun, Ibaraki
TEL
029-840-2220
Homepage URL
sasakita@ipu.ac.jp
Sponsor or person
Institute
Ibaraki Prefectural University of Health Sciences
Institute
Department
Personal name
Takeshi SASAKI
Funding Source
Organization
Ibaraki Prefectural University of Health Sciences
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Metropolitan University
Address
7-2-10 Higashiogu Arakawa-ku Tokyo
Tel
03-3819-1211
sasakita@ipu.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
| 2025 | Year | 03 | Month | 12 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
24
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
Main results already published
Date of protocol fixation
| 2022 | Year | 12 | Month | 19 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 19 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 19 | Day |
Last follow-up date
| 2024 | Year | 12 | 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
| 2025 | Year | 03 | Month | 12 | Day |
Last modified on
| 2025 | Year | 09 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057383
