UMIN-ICDS Clinical Trial

Unique ID issued by UMIN UMIN000034204
Receipt number R000038995
Scientific Title Family Cognitive Remediation Therapy for Children and Adolescents with Anorexia Nervosa: A Feasibility Study
Date of disclosure of the study information 2018/09/20
Last modified on 2023/07/06 20:35:38

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Basic information

Public title

Family Cognitive Remediation Therapy for Children and Adolescents with Anorexia Nervosa: A Feasibility Study

Acronym

Family Cognitive Remediation Therapy for Children and Adolescents with Anorexia Nervosa

Scientific Title

Family Cognitive Remediation Therapy for Children and Adolescents with Anorexia Nervosa: A Feasibility Study

Scientific Title:Acronym

Family Cognitive Remediation Therapy for Children and Adolescents with Anorexia Nervosa

Region

Japan


Condition

Condition

Anorexia Nervosa

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The objective of this study is to evaluate feasibility of Cognitive Remediation Therapy for children and adolescents with Anorexia Nervosa.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Dropout rates

Key secondary outcomes

Change in each measure(below 1-12)between the pre- and post- CRT
1.Body Mass Index
2.Standard body weight ratio
3.Blood test(leptin and ghrelin)
4.The Rey-Ostterrieth Complex Figure Test Order of Construction Index
5.The Rey-Ostterrieth Complex Figure Test Style Index
6.The Rey-Ostterrieth Complex Figure Test Central Coherence Index
7.The Brixton Spatial Anticipation Test the number of error
8.The Brixton Spatial Anticipation Test score
9.Children's version of Eating Attitude Test with 26 items/The Eating Attitude Test with 26 items
10.Motivational ruler
11.The Children's Depression Inventory/Beck's Depression Inventory-2
12.Rosenberg Self-Esteem Scale
13.Worksheets
14.Post-CRT Questionnaire(Children and adolescents)
15.Post-CRT Questionnaire(Family)
16.Dropout reasons


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Behavior,custom

Interventions/Control_1

4 sessions of Cognitive Remediation Therapy(weekly, each session 40 minutes)

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

10 years-old <=

Age-upper limit

19 years-old >

Gender

Male and Female

Key inclusion criteria

1.patients in whom anorexia nervosa was diagnosed by a psychiatrist at Shinshu University Hospital using DSM-5
2.outpatients or hospitalized patients
3.patients between age 10 and 18 years old
4.patients consenting to participation in this study

Key exclusion criteria

1.patients with an Intelligence Quotient of less than, or equal to 70
2.patients who have history of brain injury
3.patients who have history of psychosis
4.patients who have history of drug abuse/dependence
5.patients who have active suicidality
6.patients who have critical physical disease
7.patients assessed by a doctor as unfit for the study

Target sample size

10


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Rie Kuge

Organization

Shinshu University Hospital

Division name

Mental Health Clinic for Children

Zip code


Address

3-1-1 Asahi, Matsumoto, Nagano

TEL

0263-37-3060

Email

rkuge@shinshu-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Rie Kuge

Organization

Shinshu University Hospital

Division name

Mental Health Clinic for Children

Zip code


Address

3-1-1 Asahi, Matsumoto, Nagano

TEL

0263-37-3060

Homepage URL


Email

rkuge@shinshu-u.ac.jp


Sponsor or person

Institute

Shinshu University Hospital

Institute

Department

Personal name



Funding Source

Organization

Shinshu University Hospital
Shinshu Public Utility Foundation for Promotion of Medical Science

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

信州大学医学部附属病院(長野県)


Other administrative information

Date of disclosure of the study information

2018 Year 09 Month 20 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

No longer recruiting

Date of protocol fixation

2018 Year 09 Month 04 Day

Date of IRB

2018 Year 09 Month 04 Day

Anticipated trial start date

2018 Year 10 Month 01 Day

Last follow-up date

2023 Year 09 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 09 Month 19 Day

Last modified on

2023 Year 07 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000038995


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name