UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033001
Receipt number R000037547
Scientific Title The recovery of patients with mental disorders, and of their family, when treated with family behavioural interventions in an outreach programme: A single arm study
Date of disclosure of the study information 2018/06/15
Last modified on 2020/06/20 13:10:41

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Basic information

Public title

The recovery of patients with mental disorders, and of their family, when treated with family behavioural interventions in an outreach programme: A single arm study

Acronym

The BFT project

Scientific Title

The recovery of patients with mental disorders, and of their family, when treated with family behavioural interventions in an outreach programme: A single arm study

Scientific Title:Acronym

The BFT project

Region

Japan


Condition

Condition

Schizophrenia

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy of Behavioral Family Therapy to Japanese patients with schizophrenia and their families in the outreach framework

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

QPR-J itmes(Japanese version of the Questionnaire about the Process of Recovery

Key secondary outcomes

Resilience Scale-14 items version, CES-D(NIMH Center for Epidemiologic Studies-Depression Scale), GAD-7(Generalized Anxiety Disorder), FACES3(Family Adaptability and Cohesion Evaluation), Zarit Burden Interview, EuroQol-5 itmes(cost utility), CSQ-8J(Client Satisfaction Questionnaire-8-Japanese vesion)


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is considered as a block.

Blocking

NO

Concealment

No need to know


Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Behavior,custom

Interventions/Control_1

Meriden Behavioral Family Therapy as outreeach framework

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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients with the diagnsis of F2 by ICD-10(schizophrenia schizotypal or delusional disorders) and their arbitrary family members

Ability for both patients and family menbers to both understand and agree with informed consent in Japanese

Ability for both patients and family menbers to perform the intervention on the designated days after the agreement with informed consent

Key exclusion criteria

Strong suicidal ideation for either patients or family menbers

For patients receiving treatment by a mental health practitioner, unavailability of practitioner's permission for the patient to participate in the trial

Unavailability of the permission from both the immediate supervisor and the administrator of a therapist to participate in the trial

Target sample size

150


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Atsushi Sato

Organization

Kyoto Notre Dame University

Division name

Department of Social Work and Life Design

Zip code


Address

1 Minami-Nonogamicho, Shimogamo, Sakyoku, Kyoto 606-0847 Japan

TEL

075-706-3684

Email

asato@notredame.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Mirai So

Organization

Tokyo Dental College Ichikawa General Hospital

Division name

Department of Psychiatry

Zip code


Address

5-11-13 Sugano, Ichikawa-shi, Chiba, 272-8513, Japan

TEL

047-322-0151

Homepage URL


Email

somirai@tdc.ac.jp


Sponsor or person

Institute

Meriden Japan

Institute

Department

Personal name



Funding Source

Organization

Grants-in-Aid for Scientific Research

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


Email



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 06 Month 15 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

Enrolling by invitation

Date of protocol fixation

2018 Year 05 Month 20 Day

Date of IRB

2018 Year 05 Month 31 Day

Anticipated trial start date

2018 Year 06 Month 12 Day

Last follow-up date

2023 Year 06 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 06 Month 15 Day

Last modified on

2020 Year 06 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037547


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name