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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000027075
Receipt No. R000030976
Scientific Title Practicability of a Multiple Family Therapy for adolescents with Anorexia Nervosa.A Pilot Study
Date of disclosure of the study information 2017/05/01
Last modified on 2017/10/25

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Basic information
Public title Practicability of a Multiple Family Therapy for adolescents with Anorexia Nervosa.A Pilot Study
Acronym Practicability of a Multiple Family Therapy for adolescents with Anorexia Nervosa.A Pilot Study
Scientific Title Practicability of a Multiple Family Therapy for adolescents with Anorexia Nervosa.A Pilot Study
Scientific Title:Acronym Practicability of a Multiple Family Therapy for adolescents with Anorexia Nervosa.A Pilot Study
Region
Japan

Condition
Condition Anorexia Nervosa
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To study the practicability of Multiple Family Therapy for adolescents with Anorexia Nervosa
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes dropout rate/reasons
Key secondary outcomes BMI,ideal body weight,ch-EAT/EAT,Motivational ruler,BDI,RSES,GAF,GHQ-30,FACES-3,Satisfaction questionnaire post final session

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 4 sessions of Multiple Family Therapy
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
13 years-old <=
Age-upper limit
18 years-old >=
Gender Male and Female
Key inclusion criteria 1)patients who were diagnosed as anorexia nervosa by child and adolescent psychiatrists at the Department of Child and Adolescent Psychiatry at Tokyo Metropolitan Children's Medical Center, using ICD-10
2)inpatients/outpatients
3)patients and caregivers who recived psychological education of Anorexia Nervosa
4)patients between age 13 and 18 years old
5)patients consenting to participation in this study
Key exclusion criteria 1)patients with an intelligence Quotient of less than, or equal to 70
2)patients who have history of organic brain disease
3)patients who have history of Substance Related and Addictive Disorders
4)patients who have active and imminent suicidality
5)patients who have critical physical disease
6)patients judged by a doctor as unfit for the study
Target sample size 15

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuki Matsuo
Organization Tokyo Metropolitan Children's Medical Center
Division name Division of Child and Adolescent Psyciatry
Zip code
Address 2-8-29 Musashidai Fuchu-shi Tokyo
TEL 042-300-5111
Email yuuki_matsuo@tmhp.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yuki Matsuo
Organization Tokyo Metropolitan Children's Medical Center
Division name Division of Child and Adolescent Psyciatry
Zip code
Address 2-8-29 Musashidai Fuchu-shi Tokyo
TEL 042-300-5111
Homepage URL
Email yuuki_matsuo@tmhp.jp

Sponsor
Institute Tokyo Metropolitan Children's Medical Center
Institute
Department

Funding Source
Organization Tokyo Metropolitan Children's Medical Center
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
2017 Year 05 Month 01 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
2017 Year 05 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 05 Month 01 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
2017 Year 04 Month 20 Day
Last modified on
2017 Year 10 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030976

Research Plan
Registered date File name
2017/10/25 研究計画書.docx

Research case data specifications
Registered date File name

Research case data
Registered date File name


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