UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033684
Receipt number R000038403
Scientific Title 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 2019/08/19 11:32:40

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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 or person

Institute

Hamamatsu University School of Medicine

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

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

Value
https://center6.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