UMIN-CTR Clinical Trial

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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000037547