UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015521 |
|---|---|
| Receipt number | R000018003 |
| Scientific Title | Feasibility study of short-term self stigma reduction program for depression |
| Date of disclosure of the study information | 2014/12/01 |
| Last modified on | 2016/10/25 12:37:14 |
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Basic information
Public title
Feasibility study of short-term self stigma reduction program for depression
Acronym
Feasibility study of short-term self stigma reduction program for depression
Scientific Title
Feasibility study of short-term self stigma reduction program for depression
Scientific Title:Acronym
Feasibility study of short-term self stigma reduction program for depression
Region
| Japan |
Condition
Condition
Depressive Disorders(Major Depressive Disorder)
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, we aim to collect information that is useful for developing the short-term self-stigma reduction program. We interview outpatients, who are diagnosed with depressive disorders, to obtain information about perceived stigmatization. We also evaluate effectiveness of making a coping plan with stigmatization through cognitive behavioral technique.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Outcomes will be measured using the Japanese versions of the Devaluation-Discrimination Scale (DDS), Depression Self Stigma Scale (DSSS), and Rosenberg's Self Esteem Scale.
Key secondary outcomes
Subjective depression (measured with the BDI-2) and objective depression (measured with HAMD-17) score at post will be compared from the baseline.
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
| Behavior,custom |
Interventions/Control_1
Psychoeducational intervention for depression
Cognitive-behavioral intervention
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
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Outpatients with depressive symptoms diagnosed with Depressive Disorders (DSM-5) or Major Depressive Disorder (DSM-4).
2.Subjects who give full consent in the participation of the study.
Key exclusion criteria
No past treatment of GCBT or counseling.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Sakie Shimotsu |
Organization
Kobe Yamate University
Division name
Faculty for the study of Contemporary Society
Zip code
Address
6-5-2, Nakayamatedori, Chuo-ku, Kobe City, 650-0004
TEL
078-371-8000
ishimots@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Sakie Shimotsu |
Organization
Kobe Yamate University
Division name
Faculty for the study of Contemporary Society
Zip code
Address
6-5-2, Nakayamatedori, Chuo-ku, Kobe City, 650-0004
TEL
078-371-8000
Homepage URL
ishimots@gmail.com
Sponsor or person
Institute
Kobe Yamate University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
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
埼玉医科大学総合医療センター（埼玉県）、細見クリニック（宮崎県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 12 | 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 | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 12 | Month | 10 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 10 | Month | 24 | Day |
Last modified on
| 2016 | Year | 10 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018003
