UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038857 |
|---|---|
| Receipt number | 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 | 2023/06/14 11:45:53 |
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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
| Not applicable |
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 under 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 | Rie |
| Middle name | |
| Last name | Kuge |
Organization
Shinshu University Hospital
Division name
Mental Health Clinic for Children
Zip code
3908621
Address
3-1-1 Asahi Matsumoto Nagano JAPAN
TEL
0263-37-3390
rkuge@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
nakano-m5@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University Hospital
Institute
Department
Personal name
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
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
Completed
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
| 2023 | Year | 03 | Month | 31 | 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
| 2023 | Year | 06 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044286
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
