UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015097 |
|---|---|
| Receipt number | R000017564 |
| Scientific Title | Effects of a 5minutes internet-based cognitive behavioral therapy (iCBT) and easy mindfulness exercise intervention on depressive mood : a large scale randomized controlled trial |
| Date of disclosure of the study information | 2014/10/01 |
| Last modified on | 2016/04/15 16:39:38 |
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Basic information
Public title
Effects of a 5minutes internet-based cognitive behavioral therapy (iCBT) and easy mindfulness exercise intervention on depressive mood : a large scale randomized controlled trial
Acronym
Effects of a 5minutes internet-based cognitive behavioral therapy (iCBT) and easy mindfulness exercise intervention on depressive mood : RCT
Scientific Title
Effects of a 5minutes internet-based cognitive behavioral therapy (iCBT) and easy mindfulness exercise intervention on depressive mood : a large scale randomized controlled trial
Scientific Title:Acronym
Effects of a 5minutes internet-based cognitive behavioral therapy (iCBT) and easy mindfulness exercise intervention on depressive mood : RCT
Region
| Japan |
Condition
Condition
depressive mood
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine effectiveness of 5minutes ICBT and easy mindfulness exercise for depressive mood
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Center for Epidemiologis Studies Depression Scale
Key secondary outcomes
Patient Health Questionnaire 9
Generalized Anxiety Disoder-7
Base
Study type
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Maneuver |
Interventions/Control_1
5 minute ICBT
Interventions/Control_2
Easy mindfulness exesise
Interventions/Control_3
Waiting
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
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Subjects with CES-D score over the 16 at screening.
Subjects with PHQ-9 score over the 5 at screening.
Key exclusion criteria
Relevant reason decided by the CREC investigators.
Strong suicidal ideation.
Target sample size
1000
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
Chiba University Graduate School of Medicine
Research Center for Child Mental Development, Department of Cognitive Behavioral Physiology d
Institute
Department
Personal name
Funding Source
Organization
Reseach Institute of Economy, Trade and Industry (RIETI)
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
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 10 | 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
Completed
Date of protocol fixation
| 2014 | Year | 07 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 10 | 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
| 2014 | Year | 09 | Month | 09 | 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=R000017564
