UMIN-CTR Clinical Trial

Basic information
Public title	Examination of the effect of peer supporters on treatment of anorexia nervosa
Acronym	Effect of peer supporters in treating anorexia nervosa
Scientific Title	Examination of the effect of peer supporters on treatment of anorexia nervosa
Scientific Title:Acronym	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	1st name Yosuke Middle name Last name Mochizuki
Organization	Hamamatsu University School of Medicine
Division name	Department of Psychiatry
Zip code	431-3192
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	1st name Yosuke Middle name Last name Mochizuki
Organization	Hamamatsu University School of Medicine
Division name	Department of Psychiatry
Zip code	431-3192
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)

IRB Contact (For public release)
Organization	Hamamatsu University School of Medicine
Address	1-20-1, Handayama, Higasi-ku, Hamamatsu city, Shizuoka, 431-3192, Japan.
Tel	053-435-2680
Email	rinri@hama-med.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

Other administrative information
Date of disclosure of the study information	2018 Year 08 Month 08 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	Open public recruiting
Date of protocol fixation	2018 Year 07 Month 01 Day
Date of IRB	2018 Year 06 Month 05 Day
Anticipated trial start date	2018 Year 08 Month 01 Day
Last follow-up date	2023 Year 03 Month 31 Day
Date of closure to data entry	2023 Year 03 Month 31 Day
Date trial data considered complete	2023 Year 03 Month 31 Day
Date analysis concluded	2024 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date	2018 Year 08 Month 08 Day
Last modified on	2019 Year 08 Month 19 Day

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