UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019569 |
|---|---|
| Receipt number | R000022626 |
| Scientific Title | Efficacy of individual occupational therapy for patients with schizophrenia: a multicenter randomized controlled trial |
| Date of disclosure of the study information | 2015/11/01 |
| Last modified on | 2020/06/09 17:25:10 |
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Basic information
Public title
Efficacy of individual occupational therapy for patients with schizophrenia: a multicenter randomized controlled trial
Acronym
Efficacy of individual occupational therapy for patients with schizophrenia
Scientific Title
Efficacy of individual occupational therapy for patients with schizophrenia: a multicenter randomized controlled trial
Scientific Title:Acronym
Efficacy of individual occupational therapy for patients with schizophrenia
Region
| Japan |
Condition
Condition
schizophrenia
Classification by specialty
| Psychiatry | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
(1) Examine the efficacy of individual occupational therapy on cognitive impairment in schizophrenia
(2) Explore of factors related to rehospitalization of patients with schizophrenia
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
(1) Brief Assessment of Cognition in Schizophrenia-Japanese version (BACS-J)
Key secondary outcomes
(1) Schizophrenia cognition rating scale Japanese version (SCoRS-J)
(2) Social functioning scale Japanese version (SFS-J)
(3) Global assessment of functioning (GAF) scale
(4) Positive and negative syndrome scale (PANSS)
(5) Japanese version of client satisfaction questionnaire (CSQ-8J)
(6) Rehospitalization rate
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom | Maneuver |
Interventions/Control_1
The personalized occupational therapy compose of a combination of (1) individual interview, (2) self-monitoring program, (3) supports for going out and visit guidance, (4) personalized occupational guidance, (5) personalized psycho-education, and (6) guidance at the time of discharge. Occupational therapists implement to set the time one-to-one of these programs.
1-2 hours at a time and 3-5 times at a week.
Interventions/Control_2
The group occupational therapy is activity-oriented group treatment as usual.
1-2 hours at a time and 3-5 times at a week.
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) 20-65 years of age
(2) newly inpatients hospitalized in mental hospital or beds
(3) diagnosis of schizophrenia or schizoaffective disorder based on DSM-IV-TR criteria
Key exclusion criteria
(1) patients with mental retardation
(2) patients with any current or past histories of neurological disorders
(3) patients with alcohol or drug disorders (abuse or dependence)
(4) patients with need of individual intervention for physical dysfunction
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Masayoshi |
| Middle name | |
| Last name | Kobayashi |
Organization
Shinshu University
Division name
School of Health Sciences, Faculty of Medicine
Zip code
390-8621
Address
3-1-1, Asahi, Matsumoto, Nagano, Japan
TEL
0263-37-2403
mkobaya@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Shimada |
Organization
Medical Corporation Seitaikai Mental Support Soyokaze Hospital
Division name
Department of Rehabilitation
Zip code
386-0401
Address
3057-1, Shiogawa, Ueda, Nagano, Japan
TEL
0268-35-0305
Homepage URL
ot@seitaikai.or.jp
Sponsor or person
Institute
Shinshu University
Institute
Department
Personal name
Funding Source
Organization
Japanese Association of Occupational Therapists
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
Shinshu University
Address
3-1-1, Asahi, Matsumoto, Nagano, Japan
Tel
0263-37-2572
mdrinri@shinshu-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
信州大学大学院医学系研究科（長野県）、医療法人清泰会メンタルサポートそよかぜ病院（長野県）、長野県立こころの医療センター駒ヶ根（長野県）、医療法人愛生会松岡病院（長野県）、医療法人蜻蛉会南信病院（長野県）、長野県厚生農業協同組合連合会 北アルプス医療センター あづみ病院（長野県）、社会医療法人栗山会飯田病院（長野県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 11 | Month | 01 | 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
| 2015 | Year | 10 | Month | 06 | Day |
Date of IRB
| 2015 | Year | 10 | Month | 06 | Day |
Anticipated trial start date
| 2016 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 02 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 10 | Month | 30 | Day |
Last modified on
| 2020 | Year | 06 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022626
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