UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011120 |
|---|---|
| Receipt number | R000012998 |
| Scientific Title | Effectiveness Study of cognitive behavior therapy guided self-care with bulimia nervosa -an pilot study- |
| Date of disclosure of the study information | 2013/07/10 |
| Last modified on | 2019/01/07 12:48:11 |
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Basic information
Public title
Effectiveness Study of cognitive behavior therapy guided self-care with bulimia nervosa -an pilot study-
Acronym
Effectiveness Study of cognitive behavior therapy guided self-care with bulimia nervosa -an pilot study-
Scientific Title
Effectiveness Study of cognitive behavior therapy guided self-care with bulimia nervosa -an pilot study-
Scientific Title:Acronym
Effectiveness Study of cognitive behavior therapy guided self-care with bulimia nervosa -an pilot study-
Region
| Japan |
Condition
Condition
Bulimia nervosa, Eating disorder not otherwise specified
Classification by specialty
| Psychosomatic Internal Medicine | Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine effectiveness and feasibility of cognitive behavioral therapy guided self-care with bulimia nervosa and eating disorder not otherwise specified in Japanese clinical settings
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
abstinence rates from objective bingeing and vomiting
Key secondary outcomes
EDE-Q subscales (E, W, S, R, G)
BITE
PHQ-9
GAD-7
HADS
BMI
BDI
GAF
CGI
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
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
| 18 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Primary diagnosis of bulimia nervosa or eating disorder not otherwise specified
Key exclusion criteria
Individuals with who have histories of substance abuse, active suicidality, severe mental and physical condition, body mass index < 14, global assesment of functioning < 50, pervasive development disorder, intelligence quotient < 80, eating disorder examination questionnaire > 2.8 for health control, mood disorder (major depression, bipolar), and psychiatric disorders associated with substance abuse
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Eiji Shimizu |
Organization
Chiba University Graduate School of Medicine
Division name
Research Center for Child Mental Development
Zip code
Address
1-8-1,Inohana, Chuo-ku, Chiba-shi, Chiba ,260-8670,Japan
TEL
043-226-2975
kenichi.asano@chiba-u.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Michiko Nakazato |
Organization
Chiba University Graduate School of Medicine
Division name
Research Center for Child Mental Development
Zip code
Address
1-8-1, inohana, Chuo-ku, Chiba, 260-8675, Japan
TEL
043-226-2975
Homepage URL
nakazato@faculty.chiba-u.jp
Sponsor or person
Institute
Research Center for Child Mental Development, Chiba University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
The Ministry of Health, Labor and Welfare,
The Ministry of Education, Culture, Sports,Science and Technology
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
Address
Tel
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
| 2013 | Year | 07 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.ncbi.nlm.nih.gov/pubmed/29695260
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
| 2012 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 06 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 07 | Month | 04 | Day |
Last modified on
| 2019 | Year | 01 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012998
