UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009178 |
|---|---|
| Receipt number | R000010771 |
| Scientific Title | Effectiveness Study of self-help Cognitive Behavioral Therapy for Depressive Disorders-an open-label pilot study- |
| Date of disclosure of the study information | 2012/10/26 |
| Last modified on | 2014/05/29 17:08:37 |
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Basic information
Public title
Effectiveness Study of self-help Cognitive Behavioral Therapy for Depressive Disorders-an open-label pilot study-
Acronym
Self-help CBT for Depressive Disorders-pilot study-
Scientific Title
Effectiveness Study of self-help Cognitive Behavioral Therapy for Depressive Disorders-an open-label pilot study-
Scientific Title:Acronym
Self-help CBT for Depressive Disorders-pilot study-
Region
| Japan |
Condition
Condition
Depressive Disorders
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine effectiveness and feasibility of self-help CBT for depressive disorders in Japanese work place setting
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
BDI-2(Beck Depression Inventory-Second Edition)
Key secondary outcomes
SIGH-D(Japanese version of structured interview guide for the Hamilton Depression Rating Scale)
PHQ-9(Patient Health Questionnaire)
GAD-7(Generalized Anxiety Disorder)
EQ-5D(EuroQol-5D)
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
self-help 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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Primary diagnosis of Depressive Disorders
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
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiromi Isoda |
Organization
Chiba University Graduate School of Medicine
Division name
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
hiromi.isoda@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
The Ministry of Health, Labor and Welfare,
The Ministry of Education, Culture, Sports,Science and Technology
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
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
千葉大学大学院医学研究院（千葉県）
Chiba University Graduate School of Medicine(Chiba)
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 10 | Month | 26 | 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
| 2012 | Year | 07 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
| 2013 | Year | 11 | Month | 29 | Day |
Date trial data considered complete
| 2014 | Year | 01 | Month | 16 | Day |
Date analysis concluded
| 2014 | Year | 02 | Month | 03 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 10 | Month | 23 | Day |
Last modified on
| 2014 | Year | 05 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010771
| Research Plan | |
|---|---|
| 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 |
