UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Community mental health efforts for patients with severe mental disorders centering on schizophrenia in Cambodia
Title of the study (Brief title)	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	Tsutomu Aoki
Organization	Asahi General Hospital
Division name	Department of Psychiatry
Address	i-1326, Asahi City, Chiba Prefecture, Japan
TEL	0479(63)8111
Email	bluetree55@me.com

Public contact
Name of contact person	Tsutomu Aoki
Organization	Asahi General Hospital
Division name	Department of Psychiatry
Address	i-1326, Asahi City, Chiba Prefecture, Japan
TEL	0479(63)8111
Homepage URL
Email	bluetree@hospital.asahi.chiba.jp

Sponsor
Institute	The Department of Psychiatry, Asahi General Hospital
Institute
Department

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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 05 Month 02 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032856