UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012158 |
|---|---|
| Receipt number | R000014138 |
| Scientific Title | Internet cognitive behavioural therapy for major depressive disorder: a pilot randomized controlled trial |
| Date of disclosure of the study information | 2013/10/30 |
| Last modified on | 2016/04/15 16:42:10 |
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Basic information
Public title
Internet cognitive behavioural therapy for major depressive disorder: a pilot randomized controlled trial
Acronym
ICBT for major depression - a pilot RCT
Scientific Title
Internet cognitive behavioural therapy for major depressive disorder: a pilot randomized controlled trial
Scientific Title:Acronym
ICBT for major depression - a pilot RCT
Region
| Japan |
Condition
Condition
Major depressive disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine effectiveness of ICBT for Major depressive disorder
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
BDI-2(Beck Depression Inventory-Second Edition)
Key secondary outcomes
PHQ-9(Patient Health Questionnaire)
GAD-7(Generalized Anxiety Disorder)
EQ-5D(EuroQol-5D)
Base
Study type
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
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
| Maneuver |
Interventions/Control_1
Internet cognitive behavioural therapy
Interventions/Control_2
Usual care
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Primary diagnosis of Major Depressive Disorders
Subjects with BDI-2 score 14~28 at screening
Key exclusion criteria
psychotic disorder
active suicidality
organic brain disorder
antisocial personality disorder
other severe mental / physical condition
Target sample size
30
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, Department of Cognitive Behavioral Physiology
Zip code
Address
1-8-1,Inohana, Chuo-ku, Chiba-shi, Chiba ,260-8670,Japan
TEL
043-226-2027
eiji@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Remi Noguchi |
Organization
Chiba University Graduate School of Medicine
Division name
Research Center for Child Mental Development, Department of Cognitive Behavioral Physiology
Zip code
Address
1-8-1,Inohana, Chuo-ku, Chiba-shi, Chiba ,260-8670,Japan
TEL
043-226-2027
Homepage URL
remi_noguchi@chiba-u.jp
Sponsor or person
Institute
Department of Cognitive Behavioral Physiology ,Chiba University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Research Center for Child Mental Development
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
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
千葉大学医学研究院
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 10 | Month | 30 | 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
| 2013 | Year | 07 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 10 | Month | 15 | 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 | 10 | Month | 29 | Day |
Last modified on
| 2016 | Year | 04 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014138
