UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Development of a comprehensive treatment based on psychosocial approach for support for the individuals with early psychosis
Title of the study (Brief title)	Development of a comprehensive treatment based on psychosocial approach for support for the individuals with early psychosis
Region	Japan

Condition
Condition	Psychotic disorders A nurse working in a Psychiatric hospital
Classification by specialty	Psychiatry Nursing Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Focusing on individuals with early psychosis hospitalized in a psychiatric ward, we aim to: 1. provide a comprehensive assessment that covers aspects such as psychiatric symptoms and psychosocial functioning; 2. create a care plan that focuses on improving psychological adaptation and social function, 3. develop a psychoeducational and relapse prevention program for early psychosis that encompasses cognitive-behavioral approach; and 4. train more nurses in order to implement and adapt this approach to the present conditions in Japan. To achieve this, we would like to create a program in Japan that draws upon programs being used in another developed nation, the United Kingdom. Additionally, we intend to conduct surveys of patients and families as well as qualitative research including citation of individual examples on how the treatment benefits patients individually. By understanding the effectiveness of treatment, interventional needs, and satisfaction levels, we hope to develop a higher-quality support program. We will also conduct a questionnaire survey regarding nurses'level of interest in this psychosocial approach, and their thoughts on its future feasibility.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Psychiatric symptoms: We will assess psychiatric symptoms using the Positive And Negative Syndrome Scale, Beck Cognitive Insight Scale, and Beck Depression Inventory. Surveys: We will survey the level of insufficiency of and level of satisfaction with the service via self-evaluations regarding the outcome of the program, and assess the knowledge of and response to the treatment and the illness. These surveys will be conducted on both patients and their families separately. An additional survey will be conducted targeting on the nurses who would provide the service based on present program in the future.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom Other
Interventions/Control_1	1. Comprehensive assessment: We aim to perform initial assessments in around 3 sessions. 2. Creation of the care plan: The care plan will be created after conducting the comprehensive assessments, and will be based on the information acquired from the psychiatrists and other staffs in charge of the patients. 3. Psychosocial intervention: The psychosocial intervention will be performed in accordance with the care plan, to support the patients' psychological issues and social functioning, and to provide psychoeducation, as required. 4. Performance of relapse drills: Relapse drills will be performed in accordance with the relapse-drill protocol. An additional survey will be conducted targeting on the nurses who would provide the service based on present program in the future.
Interventions/Control_2
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	14 years-old <=
Age-upper limit	36 years-old >
Gender	Male and Female
Key inclusion criteria	Inclusion criteria: We will target approximately 20 individuals with psychotic disorders aged 14 to 36 years, who have had an onset of a psychotic disorder within the past five years. Diagnosis will be based on the Diagnostic and Statistical Manual of Mental Disorders-IV (American Psychiatric Association), and diagnoses may include brief psychotic disorder, schizophreniform disorder, schizophrenia, delusional disorder, schizoaffective disorder, and mood disorders with psychotic features.
Key exclusion criteria	Cases with neurological disorders or substance dependence will be excluded.
Target sample size	20

Research contact person
Name of lead principal investigator	Norika Mitsunaga
Organization	Tohoku University Graduate School of Medicine
Division name	2-1,Seiryo-machi, Aoba-Ku, Sendai, 980-8575, Japan
Address	+81-22-717-7916
TEL	022-717-7916
Email	mitsuanga@med.tohoku.ac.jp

Public contact
Name of contact person	Norika Mitsunaga
Organization	Tohoku University Graduate School of Medicine
Division name	2-1,Seiryo-machi, Aoba-Ku, Sendai, 980-8575, Japan
Address	+81-22-717-7916
TEL	022-717-7916
Homepage URL
Email	mitsuanga@med.tohoku.ac.jp

Sponsor
Institute	Tohoku University
Institute
Department

Funding Source
Organization	Tohoku University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
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	2018 Year 02 Month 20 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2013 Year 03 Month 15 Day
Anticipated trial start date	2017 Year 02 Month 20 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
Other related information

Management information
Registered date	2018 Year 02 Month 13 Day
Last modified on	2018 Year 02 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035603