UMIN-CTR Clinical Trial

Basic information
Public title	A study on the effect of peer support activities to patients with anorexia nervosa on recovery of peer supporters
Acronym	Recovery of peer supporters with Anorexia nervosa
Scientific Title	A study on the effect of peer support activities to patients with anorexia nervosa on recovery of peer supporters
Scientific Title:Acronym	Recovery of peer supporters with Anorexia nervosa
Region	Japan

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

Objectives
Narrative objectives1	The purpose of this study is to examine the effect of peer support activities to patients with Anorexia nervosa on the recovery of peer supporters themselves.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Recovery Assessment Scale(Japanese version) It will be carried out within one month after obtaining research consent. During the research period, this evaluation is continued every 3 months.
Key secondary outcomes	Body Mass Index Eating Disorder Instrument-2(Japanese version) Eating Attitudes Test-26(Japanese version) Self-identified stage of recovery Part-A, Part-B(Japanese version) Beck Hopelessness Scale(Japanese version) Self-esteem scale It will be carried out within one month after obtaining research consent. During the research period, these evaluations are continued every 3 months.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification	NO
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	We will make the peer supporters participate in group therapy for patients with anorexia nervosa. The group therapy is set once a month, 18 times in total. We will let the peer supporters join the support group for them once a month.
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	18 years-old <=
Age-upper limit	Not applicable
Gender	Female
Key inclusion criteria	1 Women over the age of 18 who has been diagnosed anorexia nervosa at DSM-5. 2 Women who has been treated as outpatient or hospitalized at Hamamatsu University School of Medicine Department of Psychiatry. 3 Women who judged that the psychiatric doctor is capable of activities as a peer supporter 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	10

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 Medicene, Department of Psychiatry
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 06 Month 19 Day
Date of IRB	2018 Year 06 Month 11 Day
Anticipated trial start date	2018 Year 07 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=R000038310