UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000417 |
|---|---|
| Receipt number | R000000508 |
| Scientific Title | A randomized controlled trial to evaluate its effectiveness of an Assertive Community Treatment (ACT) program for people with severe mental illness |
| Date of disclosure of the study information | 2006/05/11 |
| Last modified on | 2014/03/05 10:53:42 |
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Basic information
Public title
A randomized controlled trial to evaluate its effectiveness of an Assertive Community Treatment (ACT) program for people with severe mental illness
Acronym
RCT to evaluate its effectiveness of an ACT program for people with severe mental illness
Scientific Title
A randomized controlled trial to evaluate its effectiveness of an Assertive Community Treatment (ACT) program for people with severe mental illness
Scientific Title:Acronym
RCT to evaluate its effectiveness of an ACT program for people with severe mental illness
Region
| Japan |
Condition
Condition
Schizophrenia, mood disorders, other
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate service effectiveness of a community mental health program for people with severe mental illness
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Numbers and days of rehospitalization, number of psychiatric emergency room use, months of no-show to outpatient clinics
Key secondary outcomes
Psychiatric symptoms, social functioning, and quality of life
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Community based services with the principle of Assertive Community Treatment program
Interventions/Control_2
Traditional, hospital-based psychiatric and psychosocial rehabilitation services
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
| 59 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Residence: I, M, or F city
2.Age: 18-59 years old
3.Primary Diagnosis:
Schizophrenia, mood disorder, organic disorder, and other disorders
4.High psychiatric service utilization
in last two years (2+ hospitalization/100+inpatient days/3+psychiatric ER1) use/3+Mo no-show)
5.Low level of social functioning in the previous year (Less than 50 of GAF2) score at best
Patients with schizophrenia or mood disorder must meet criteria either 4 or 5.
Patients with other disorders must meet criteria both 4 and 5.
Key exclusion criteria
Dementia, substance related disorders, mental retardation, personality disorders
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Junichiro Ito |
Organization
National Center of Neurology and Psychiatry, National Institute of Mental Health
Division name
Dep. of Psychiatric rehabilitation
Zip code
Address
1-7-1 Kohnodai, Ichikawa
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
National Institute of Mental Health
Division name
Dep. of Psychiatric rehabilitation
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
National Center of Neurology and Psychiatry
Institute
Department
Personal name
Funding Source
Organization
Japan Foundation for Aging and Health
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2006 | Year | 05 | Month | 11 | 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
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
| 2004 | Year | 04 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2004 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2007 | Year | 12 | 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
| 2006 | Year | 05 | Month | 11 | Day |
Last modified on
| 2014 | Year | 03 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000508
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
