UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000024345
Receipt number 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 19:29:36

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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 or person

Institute

Tokyo Metroporitan 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


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

Value
https://center6.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