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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000038857
Receipt No. R000044286
Scientific Title Study on the group psychoeducation for the families of adolescent patients with anorexia nervosa.
Date of disclosure of the study information 2019/12/11
Last modified on 2019/12/11

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Basic information
Public title Study on the group psychoeducation for the families of adolescent patients with anorexia nervosa.
Acronym Study on the group psychoeducation for the families of adolescent patients with anorexia nervosa.
Scientific Title Study on the group psychoeducation for the families of adolescent patients with anorexia nervosa.
Scientific Title:Acronym Study on the group psychoeducation for the families of adolescent patients with anorexia nervosa.
Region
Japan

Condition
Condition anorexia nervosa
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 1) Evaluate the feasibility of group psychoeducation for the families of adolescent patients with anorexia nervosa.
2)Evaluate the effectiveness of the program for patients' condition, mental health and quality of life (QOL) of families, and family function.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase I

Assessment
Primary outcomes a) The score of QIDS(Quick Inventory Depressive Symptomatology) of the patients' families after the program
Key secondary outcomes post-program
b) Patient weight
c) Family function(FACESKG-16(version3))
d) QOL of families (MOS 36-Item Short-Form Health Survey)
e) Program the degree of satisfaction after the program(original questionnaire)
f) Changes in remark of families (Video shooting)

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 Educational,Counseling,Training
Type of intervention
Other
Interventions/Control_1 4 sessions of weekly group psychoeducation (lecture and discussion).
The program involves psychiatrists, clinical psychologists, nutritionists, nurses, occupatinal therapists.
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
12 years-old <=
Age-upper limit
19 years-old >
Gender Male and Female
Key inclusion criteria a) Participants have children or adolescents diagnosed with anorexia nervosa using DSM-5.
b) Children of participants are between 12-18 years old.
c) Participants who are allowed to take part in this research by attending psychiatrist of the patient
d) Participants are able to give written informed consent by free will after received sufficient explanation about this research
Key exclusion criteria Participants
a) unable to give consent to participate in this research.
b) who are not allowed to take part in this research by attending psychiatrist of the patient.
c) not allowed to take part in this research by principal investigator
Target sample size 15

Research contact person
Name of lead principal investigator
1st name Nobuhiro
Middle name
Last name Sugiyama
Organization Shinshu University
Division name School of Health Sciences Department of Applied Occupational Therapy
Zip code 3908621
Address 3-1-1 Asahi Matsumoto Nagano JAPAN
TEL 0263-37-2402
Email nsugi@shinshu-u.ac.jp

Public contact
Name of contact person
1st name Miku
Middle name
Last name Nakano
Organization Shinshu University Hospital
Division name Rehabilitation Center
Zip code 3908621
Address 3-1-1 Asahi Matsumoto Nagano JAPAN
TEL 0263-37-2836
Homepage URL
Email nakano-m5@shinshu-u.ac.jp

Sponsor
Institute Shinshu University Hospital
Institute
Department

Funding Source
Organization None
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 Shinshu University
Address 3-1-1 Asahi Matsumoto Nagano
Tel 0263-37-2572
Email mdrinri@shinshu-u.ac.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 信州大学医学部附属病院(長野県)

Other administrative information
Date of disclosure of the study information
2019 Year 12 Month 11 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
2019 Year 11 Month 06 Day
Date of IRB
2019 Year 11 Month 06 Day
Anticipated trial start date
2019 Year 11 Month 06 Day
Last follow-up date
2022 Year 10 Month 08 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 12 Month 11 Day
Last modified on
2019 Year 12 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044286

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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