UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031268 |
|---|---|
| Receipt number | R000035603 |
| Scientific Title | Development of a comprehensive treatment based on psychosocial approach for support for the individuals with early psychosis |
| Date of disclosure of the study information | 2018/02/20 |
| Last modified on | 2018/02/13 13:18:29 |
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Basic information
Public title
Development of a comprehensive treatment based on psychosocial approach for support for the individuals with early psychosis
Acronym
Development of a comprehensive treatment based on psychosocial approach for support for the individuals with early psychosis
Scientific Title
Development of a comprehensive treatment based on psychosocial approach for support for the individuals with early psychosis
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Norika Mitsunaga |
Organization
Tohoku University Graduate School of Medicine
Division name
2-1,Seiryo-machi, Aoba-Ku, Sendai, 980-8575, Japan
Zip code
Address
+81-22-717-7916
TEL
022-717-7916
mitsuanga@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Norika Mitsunaga |
Organization
Tohoku University Graduate School of Medicine
Division name
2-1,Seiryo-machi, Aoba-Ku, Sendai, 980-8575, Japan
Zip code
Address
+81-22-717-7916
TEL
022-717-7916
Homepage URL
mitsuanga@med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
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)
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
| 2018 | Year | 02 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Partially 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
Main results already published
Date of protocol fixation
| 2013 | Year | 03 | Month | 15 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035603
