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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024345
Receipt No. R000028029
Scientific Title The study of an occupational therapy group program utilizing the method of "drawing one's Inner Weather"promoting their expressions of valuable occupations for psychiatric day care users.
Date of disclosure of the study information 2016/10/09
Last modified on 2017/10/13

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Basic information
Public title The study of an occupational therapy group program utilizing the method of "drawing one's Inner Weather"promoting their expressions of valuable occupations for psychiatric day care users.
Acronym The study of an occupational therapy group program utilizing the method of "drawing one's Inner Weather"promoting their expressions of valuable occupations for psychiatric day care users.
Scientific Title The study of an occupational therapy group program utilizing the method of "drawing one's Inner Weather"promoting their expressions of valuable occupations for psychiatric day care users.
Scientific Title:Acronym The study of an occupational therapy group program utilizing the method of "drawing one's Inner Weather"promoting their expressions of valuable occupations for psychiatric day care users.
Region
Japan

Condition
Condition Schizophrenia, Mood disorder, Epilepsy
Classification by specialty
Psychosomatic Internal Medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is examining the efficacy of an occupational therapy group program utilizing the "drawing one's Inner Weather" of which aim is to assist psychiatric day care users express and promote better understanding of the valuable occupations in their daily lives, to be able to live by their own values.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase II,III

Assessment
Primary outcomes Evaluation time: pre-intervention and post-intervention (after 12 weeks).
Evaluation form: free description type questionnaire about "matters you want to improve in your daily life".
Key secondary outcomes Evaluation time: pre-intervention and post-intervention (after 12 weeks).
Evaluation form: WHO Quality of Life 26 (WHO QOL26),Occupational Self Assessment Version 2.1 (OSA II) and Life Assessment Scale for the Mentally III (LASMI).

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Pseudo-randomization

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 Intervention group: The occupational therapy group will use a so-called "drawing one's internal weather map" method (90 minutes, once per week, 12 weeks).
Interventions/Control_2 Control group: usual psychiatric day care program (12 weeks).
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) Use a psychiatric day care service
2) Understand the research contents, and agree to participate it
Key exclusion criteria 1) Not be able to continue attending psychiatric day care setting during research period
2) Unstable mental condition
3) Unable to communicate verbally
4) Unable to complete self-completed evaluation forms
5) Unable to adapt to groups
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Sachina Komikado
Organization Tokyo Metroporitan University
Division name Master Course, Department of Occupational Therapy, Graduate School of Human Health Sciences
Zip code
Address 7-2-10, Higashiogu, Arakawa-ku, Tokyo, Japan
TEL 03-3819-1211
Email komikado-sachina@ed.tmu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Sachina Komikado
Organization Tokyo Metroporitan University
Division name Master Course, Department of Occupational Therapy, Graduate School of Human Health Sciences
Zip code
Address 7-2-10, Higashiogu, Arakawa-ku, Tokyo, Japan
TEL 03-3819-1211
Homepage URL
Email komikado-sachina@ed.tmu.ac.jp

Sponsor
Institute Tokyo Metroporitan 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
Address
Tel
Email

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
2016 Year 10 Month 09 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
2016 Year 07 Month 22 Day
Date of IRB
Anticipated trial start date
2016 Year 10 Month 08 Day
Last follow-up date
2017 Year 09 Month 15 Day
Date of closure to data entry
2017 Year 10 Month 01 Day
Date trial data considered complete
2017 Year 12 Month 31 Day
Date analysis concluded
2018 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2016 Year 10 Month 09 Day
Last modified on
2017 Year 10 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028029

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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