UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000033683
Receipt No. R000038310
Official scientific title of the study A study on the effect of peer support activities to patients with anorexia nervosa on recovery of peer supporters
Date of disclosure of the study information 2018/08/08
Last modified on 2018/08/08

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Official scientific title of the study A study on the effect of peer support activities to patients with anorexia nervosa on recovery of peer supporters
Title of the study (Brief title) 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 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 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)

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 06 Month 19 Day
Anticipated trial start date
2018 Year 07 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=R000038310

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.