UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027075 |
|---|---|
| Receipt number | 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 | 2021/02/21 22:14:26 |
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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 | Yuki |
| Middle name | |
| Last name | Matsuo |
Organization
Tokyo Metropolitan Children's Medical Center
Division name
Division of Child and Adolescent Psyciatry
Zip code
1838561
Address
2-8-29 Musashidai Fuchu-shi Tokyo
TEL
042-300-5111
yuuki_matsuo@tmhp.jp
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Matsuo |
Organization
Tokyo Metropolitan Children's Medical Center
Division name
Division of Child and Adolescent Psyciatry
Zip code
1838561
Address
2-8-29 Musashidai Fuchu-shi Tokyo
TEL
042-300-5111
Homepage URL
yuuki_matsuo@tmhp.jp
Sponsor or person
Institute
Tokyo Metropolitan Children's Medical Center
Institute
Department
Personal name
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
Tokyo Metropolitan Children's Medical Center
Address
2-8-29 Musashidai Fuchu-shi Tokyo
Tel
042-300-5111
yuuki_matsuo@tmhp.jp
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
| 2021 | Year | 02 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030976
