UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039485 |
|---|---|
| Receipt number | R000045023 |
| Scientific Title | Guided Internet-based cognitive behavioral therapy for anorexia nervosa: a pilot single-arm study |
| Date of disclosure of the study information | 2020/02/14 |
| Last modified on | 2021/06/24 02:26:12 |
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Basic information
Public title
Guided Internet-based cognitive behavioral therapy for anorexia nervosa: a pilot single-arm study
Acronym
Guided ICBT for anorexia nrevosa: a pilot feasibility study
Scientific Title
Guided Internet-based cognitive behavioral therapy for anorexia nervosa: a pilot single-arm study
Scientific Title:Acronym
Guided ICBT for anorexia nrevosa: a pilot feasibility study
Region
| Japan |
Condition
Condition
anorexia nrevosa
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine effectiveness and feasibility of Guided Internet-based cognitive behavioral therapy for patients with anorexia nrevosa
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The change of EDE-Q global score for pre- and post- 12 weeks-treatment
Key secondary outcomes
Eating Disorder examination questionnaire (EDE-Q)(Restraint;Eating Concern; Shape Concern; Weight Concern)
Body Checking Questionnaire(BCQ)
Body shape questionnaire(BSQ)
Metacognitions Questionnaire(MCQ-30)
Body Mass Index(BMI)
Menstrual abnormalities
EQ-5D
Client Satisfaction Questionnaire(CSQ)
Working Alliance Inventory Short Form (WAI-SF)
Patient Health Questionnaire-9 (PHQ-9)
Generalized Anxiety Disorder -7 (GAD-7)
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
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Guided Internet-Based Cognitive Behavioral Therapy
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
| 15 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Female
Key inclusion criteria
Patients who met the current diagnosis of anorexia nervosa according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria
Key exclusion criteria
Psychotic disorder
Highly likely to attempt suicide
Organic brain complications/disorders
Antisocial personality disorder
Mental retardation
Other severe mental / physical condition
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Jumpei |
| Middle name | |
| Last name | Takahashi |
Organization
Chiba University
Division name
Research center for child mental development
Zip code
260-8677
Address
1-8-1, Inohana, Chuouku, Chiba, Japan
TEL
043-226-2027
recruit3@chiba-u.jp
Public contact
Name of contact person
| 1st name | Sayo |
| Middle name | |
| Last name | Hamatani |
Organization
Chiba University
Division name
Research center for child mental development
Zip code
260-8677
Address
1-8-1, Inohana, Chuouku, Chiba, Japan
TEL
043-226-2027
Homepage URL
ahna0286@chiba-u.jp
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
Funding Source
Organization
Japan society for the promotion of science
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
Chiba university
Address
1-8-1, Inohana, Chuouku, Chiba, Japan
Tel
0432262616
prc-jim@chiba-u.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
| 2020 | Year | 02 | Month | 14 | 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
Completed
Date of protocol fixation
| 2020 | Year | 01 | Month | 06 | Day |
Date of IRB
| 2020 | Year | 01 | Month | 06 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 06 | Day |
Last follow-up date
| 2020 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2020 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 05 | Month | 07 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 02 | Month | 14 | Day |
Last modified on
| 2021 | Year | 06 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045023
