UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003331 |
|---|---|
| Receipt number | R000004021 |
| Scientific Title | Biological predictors of responsiveness to cognitive behaviour therapy for anxiety disorders, depression and bulimia nervosa: a randomised controlled trial. |
| Date of disclosure of the study information | 2010/04/01 |
| Last modified on | 2015/06/24 15:47:14 |
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Basic information
Public title
Biological predictors of responsiveness to cognitive behaviour therapy for anxiety disorders, depression and bulimia nervosa: a randomised controlled trial.
Acronym
A randomised controlled trial of cognitive behaviour therapy and biological predictors.
Scientific Title
Biological predictors of responsiveness to cognitive behaviour therapy for anxiety disorders, depression and bulimia nervosa: a randomised controlled trial.
Scientific Title:Acronym
A randomised controlled trial of cognitive behaviour therapy and biological predictors.
Region
| Japan |
Condition
Condition
anxiety disorders, obsessive compulsive disorders, eating disorders, depression and related disorders
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study was to compare the efficacy and cost-effectiveness of cognitive behaviour therapy (CBT) and treatment as usual (TAU) in patients with anxiety disorders, obsessive compulsive disorders, bulimia nervosa, depressive disorders and related disorders.
Basic objectives2
Others
Basic objectives -Others
The aim of this study was to investigate biomarkers of predictors for the responders to CBT.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Body mass index(BMI), frequency of binge-eating and purging behaviours,BITE,EDEQ,HADS,YBOCS
Key secondary outcomes
Wisconsin Card Sorting Test (WCST), Trail Making Test,Iowa Gambling Task(IGT),NIRS,p-50,serum brain-derived neurotrophic factor (BDNF), serum amino acids
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom | Maneuver |
Interventions/Control_1
Participants were randomly assigned to waiting list or individual CBT guided self-care supported by therapists. Therapists were regularly supervised by professional CBT psychiatrists or psychologists.
Interventions/Control_2
Participants assigned to waiting list received treatment as usual (TAU).
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
| 7 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Participants were recruited at the Department of Psychiatry, Department of Child Psychiatry, Chiba University Hospital. Written informed consent was sought from participants. They were 7-75 years of age, met DSM-IV criteria for anxiety disorders, obsessive compulsive disorders, bulimia nervosa, depressive disorders and related disorders.
Key exclusion criteria
We excluded patients with a body mass index below 15, patients suffering from severe mental illness, or substance dependence, pervasive developmental disorders, learning disability, severe physical illness, at risk for self-injury or suicidal attempt, patients with GAF score below 50, mental retardation and mental disability (IQ<80).
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masaomi Iyo |
Organization
Chiba University Graduate School of Medicine, Chiba
Division name
Department of Psychiatry
Zip code
Address
1-8-1 Inohana, Chuo-ku, Chiba 2608677 JAPAN
TEL
043-226-2297
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Michiko Nakaztao |
Organization
Chiba University Hospital
Division name
Department of Child Psychiatry
Zip code
Address
1-8-1 Inohana, Chuo-ku, Chiba 2608677 JAPAN
TEL
043-226-2297
Homepage URL
nakazato@faculty.chiba-u.jp
Sponsor or person
Institute
Department of Psychiatry, Chiba University Graduate School of Medicine, Chiba
Institute
Department
Personal name
Funding Source
Organization
Department of Psychiatry, Chiba University Graduate School of Medicine, Chiba
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Department of Integrative Neurophysiology
Chiba University Graduate School of Medicine
Name of secondary funder(s)
Division of Clinical Neuroscience, ChibaUniversity Center for Forensic Mental Health
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
千葉大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 04 | Month | 01 | 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
Terminated
Date of protocol fixation
| 2010 | Year | 03 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2015 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2015 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2016 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 03 | Month | 13 | Day |
Last modified on
| 2015 | 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=R000004021
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
