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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000033684
Receipt No. R000038403
Official scientific title of the study Examination of the effect of peer supporters on treatment of anorexia nervosa
Date of disclosure of the study information 2018/08/08
Last modified on 2018/08/08

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Basic information
Official scientific title of the study Examination of the effect of peer supporters on treatment of anorexia nervosa
Title of the study (Brief title) Effect of peer supporters in treating anorexia nervosa
Region
Japan

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

Objectives
Narrative objectives1 This study is to examine the effect of group therapy in cooperation with peer supporters for patients with anorexia nervosa.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Eating Disorder Instrument-2

This evaluations are conducted at the time of consent of participating in the research, at the end of group therapy, and 6 months after finishing group therapy.
Key secondary outcomes 1 Body Mass Index
2 Eating Attitudes Test-26
3 Recovery Assessment Scale
4 Self-identified stage of recovery Part-A, Part-B
5 Beck Hopelessness Scale
6 Self-esteem scale

These evaluations are conducted at the time of consent of participating in the research, at the end of group therapy, and 6 months after finishing group therapy.

Base
Study type Interventional

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

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Patients with anorexia nervosa participate in group therapies with peer supporters. Group therapy, once a month, total 18 times.

Interventions/Control_2 The control group for examining the therapeutic effect is patients with anorexia nervosa who had received usual inpatient treatment after being hospitalized in the psychiatric department of Hamamatsu University School of Medicine.
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
18 years-old <=
Age-upper limit
50 years-old >
Gender Female
Key inclusion criteria 1 Women who meets the diagnostic criteria of anorexia nervosa at DSM - 5 and is hospitalized in the psychiatry neurology department of Hamamatsu University School of Medicine .
2 women whose score of BMI is 14 or more.
3 Those whose age is 18 to 50 years old.
4 With regard to this research, those who were able to obtain consent from the participants themselves or parents etc. by signature.
Key exclusion criteria 1 When a mental disorder other than Anorexia nervosa is the subject.
2 Cases with severe physical complications.
3 When their physical condition is unstable or pregnant.
4 Severe death idea and suicide related behavior is recognized.
5 In cases where the psychiatric doctor judges that participation in research is inappropriate.
Target sample size 30

Research contact person
Name of lead principal investigator Yosuke Mochizuki
Organization Hamamatsu University School of Medicine
Division name Department of Psychiatry
Address 1-20-1, Handayama, Higasi-ku, Hamamatsu city, Shizuoka, 431-3192, Japan.
TEL 053-435-2295
Email yosuke-m@hama-med.ac.jp

Public contact
Name of contact person Yosuke Mochizuki
Organization Hamamatsu University School of Medicine
Division name Department of Psychiatry
Address 1-20-1, Handayama, Higasi-ku, Hamamatsu city, Shizuoka, 431-3192, Japan.
TEL 053-435-2295
Homepage URL
Email yosuke-m@hama-med.ac.jp

Sponsor
Institute Hamamatsu University School of Medicine
Institute
Department

Funding Source
Organization Japan Science and Technology Agency
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

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 08 Month 08 Day

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2018 Year 07 Month 01 Day
Anticipated trial start date
2018 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 08 Month 08 Day
Last modified on
2018 Year 08 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038403

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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