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
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
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
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
