UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018840 |
|---|---|
| Receipt number | R000021791 |
| Scientific Title | The effect of family psychoeducation in depression |
| Date of disclosure of the study information | 2015/10/01 |
| Last modified on | 2020/04/03 16:18:29 |
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Basic information
Public title
The effect of family psychoeducation in depression
Acronym
The effect of family psychoeducation in depression
Scientific Title
The effect of family psychoeducation in depression
Scientific Title:Acronym
The effect of family psychoeducation in depression
Region
| Japan |
Condition
Condition
Depression
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Confirm that the effect of family psychoeducation on improvement of prognosis of depression
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
the rate of recurrence of the depression during 9 moths
Key secondary outcomes
BDI (Beck Depression Inventory)
HAM-D (Hamilton Rating Scale for Depression)
CGI (Clinical Global Impressions)
FMSS (Five Minute Speech Sample)
FAS (Family Attitude Scale)
GHQ-12(General Health Questionnaire)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Group of Family Psychoeducation
Interventions/Control_2
Group of non Family Psychoeducation (Control)
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients diagnosed by DSM-V
Patients and their family
Key exclusion criteria
None
Target sample size
125
Research contact person
Name of lead principal investigator
| 1st name | Hirokazu |
| Middle name | |
| Last name | Fujita |
Organization
Kochi Medical School
Division name
Center to Promote Creativity in Medical Education
Zip code
7838505
Address
Kohasu, Oko-cho, Nankoku, Kochi
TEL
088-880-2291
fujitah@kochi-u.ac.jp
Public contact
Name of contact person
| 1st name | Hirokazu |
| Middle name | |
| Last name | Fujita |
Organization
Kochi Medical School
Division name
Center to Promote Creativity in Medical Education
Zip code
7838505
Address
Kohasu, Oko-cho, Nankoku, Kochi
TEL
088-880-2291
Homepage URL
fujitah@kochi-u.ac.jp
Sponsor or person
Institute
Kochi Medical School
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the promotion of science
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
Ethical Review Board of Kochi Medical School
Address
Kohasu, Oko-cho, Nankoku, Kochi
Tel
088-866-5811
rinri21@kochi-u.ac.jp
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
| 2015 | 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
| 2015 | Year | 09 | Month | 30 | Day |
Date of IRB
| 2015 | Year | 10 | Month | 27 | Day |
Anticipated trial start date
| 2015 | Year | 10 | Month | 27 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 08 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 08 | Month | 28 | Day |
Last modified on
| 2020 | Year | 04 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021791
