UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033683 |
|---|---|
| Receipt number | R000038310 |
| Scientific Title | 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 | 2019/08/19 11:36:34 |
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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
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
yosuke-m@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicene, Department of Psychiatry
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038310
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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