UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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.
Title of the study (Brief 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.
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	Sachina Komikado
Organization	Tokyo Metroporitan University
Division name	Master Course, Department of Occupational Therapy, Graduate School of Human Health Sciences
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	Sachina Komikado
Organization	Tokyo Metroporitan University
Division name	Master Course, Department of Occupational Therapy, Graduate School of Human Health Sciences
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 07 Month 22 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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