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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000033001
Receipt No. 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 2019/01/18

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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
Institute Meriden Japan
Institute
Department

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
Anticipated trial start date
2018 Year 06 Month 12 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 06 Month 15 Day
Last modified on
2019 Year 01 Month 18 Day


Link to view the page
URL(English) https://upload.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


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