UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029139 |
|---|---|
| Receipt number | R000032856 |
| Scientific Title | Community mental health efforts for patients with severe mental disorders centering on schizophrenia in Cambodia |
| Date of disclosure of the study information | 2017/09/14 |
| Last modified on | 2017/09/14 11:22:25 |
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Basic information
Public title
Community mental health efforts for patients with severe mental disorders centering on schizophrenia in Cambodia
Acronym
Community mental health efforts for patients with severe mental disorders centering on schizophrenia in Cambodia
Scientific Title
Community mental health efforts for patients with severe mental disorders centering on schizophrenia in Cambodia
Scientific Title:Acronym
Community mental health efforts for patients with severe mental disorders centering on schizophrenia in Cambodia
Region
| Asia(except Japan) |
Condition
Condition
Severe Mental Disorders
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Patients with severe mental disorders centering on schizophrenia, have not been able to receive mental health services in low- and middle-income countries . Efforts have been made on this important issue.
In Japan, for the treatment of patients with severe psychiatric disorders including schizophrenia, the effectiveness of supporting regional living, with multidisciplinary teams including doctors, nurses, clinical psychologists, social workers, etc., has been shown . In this intervention study, we verify the effectiveness of relocating/introducing technology in low- and middle-income countries according to local circumstances. We aim to develop a simple mental symptom evaluation scale, to verify its effectiveness, and to improve the mental health care gap between low- and middle- income countries and high-income countries. In addition, in the questionnaire survey, researchers will conduct the same mental health consciousness survey done by SUMH on the above-mentioned community mental health activities before the start of activity, and compare the results before and after in order to validate the effectiveness of community mental health activities in low- and middle-income countries.
These studies will demonstrate the effectiveness of community mental health services for patients with severe mental disorders centered on schizophrenia in low- and middle-income countries, and by promoting such efforts in low- and middle-income countries, it can be expected that the well-being of patients with severe psychiatric disorders will improve.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
1.The rate of change of BPRS due to the following intervention
Psychological education for patients and families by multidisciplinary team
Outreach service by multidisciplinary team
2. Changes in mental health awareness in 2001 and 2017
Key secondary outcomes
1.Change rate of psychiatric rehabilitation table at the end of 2 years follow-up
Change rate of GAF at the end of follow-up for 2 years
CGI-C at the end of tracking for 2 years
2.Changes in feelings and behaviors when I met a person with mental disability in 2001 and 2017
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Random allocation open comparison
Perform outreach service by multioccupational team and compare treatment continuation rate, family load, recurrence rate, treatment continuation rate, in the intervention group and the nonintervention group.
Interventions/Control_2
Psychoeducational intervention is given to patients and their families, and knowledge on schizophrenia, family load, recurrence rate, and treatment continuation rate are compared between intervention group and nonintervention group.
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
| 16 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Persons diagnosed with schizophrenia based on ICD-10 diagnostic criteria (WHO);
2) Persons between 16 and 65 years old when giving consent.
Key exclusion criteria
1) A history of head injury accompanied by loss of consciousness in the past;
2) A diagnosis of central nervous system disease (including epilepsy, inflammatory disease, degenerative disease, cerebrovascular disease), or suspicions of such a disease;
3) Severe heart disease, respiratory disease, gastrointestinal disease, kidney disease, or poor general health;
4) A diagnosis of malignant tumor and currently receiving treatment;
5) Pregnant or suspected to be pregnant;6) Lactating;
7) Others deemed inappropriate for participation in this research by the attending physician.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tsutomu Aoki |
Organization
Asahi General Hospital
Division name
Department of Psychiatry
Zip code
Address
i-1326, Asahi City, Chiba Prefecture, Japan
TEL
0479(63)8111
bluetree55@me.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tsutomu Aoki |
Organization
Asahi General Hospital
Division name
Department of Psychiatry
Zip code
Address
i-1326, Asahi City, Chiba Prefecture, Japan
TEL
0479(63)8111
Homepage URL
bluetree@hospital.asahi.chiba.jp
Sponsor or person
Institute
The Department of Psychiatry, Asahi General Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Supporters for Mental Health
Transcultural Psychiatric Organization Cambodia
The Department of Psychiatry, Cambodia Siem Reap Provincial Hospital
Kinshicho Kubota Clinic
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
| 2017 | Year | 09 | Month | 14 | 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
Preinitiation
Date of protocol fixation
| 2017 | Year | 05 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 30 | Day |
Date of closure to data entry
| 2020 | Year | 03 | Month | 30 | Day |
Date trial data considered complete
| 2020 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2021 | Year | 03 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 09 | Month | 14 | Day |
Last modified on
| 2017 | Year | 09 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032856
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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