UMIN-ICDS Clinical Trial

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

Psychotic disorders
A nurse working in a Psychiatric hospital

Classification by specialty

Psychiatry	Nursing	Adult

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

Email

mitsuanga@med.tohoku.ac.jp

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

Email

mitsuanga@med.tohoku.ac.jp

Institute

Tohoku University

Institute

Department

Personal name

Organization

Tohoku University

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2018

Year

02

Month

20

Day

URL releasing protocol

Publication of results

Partially published

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

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 related 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/icdr_e/ctr_view.cgi?recptno=R000035603