UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049934 |
|---|---|
| Receipt number | R000056872 |
| Scientific Title | A multicenter intervention study on the effectiveness of group psychoeducation using depression guidelines for patients to prevent relapse |
| Date of disclosure of the study information | 2022/12/28 |
| Last modified on | 2024/01/02 19:13:52 |
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Basic information
Public title
A multicenter intervention study on the effectiveness of group psychoeducation using depression guidelines for patients to prevent relapse
Acronym
Group psychoeducation study with depression guidelines for patients
Scientific Title
A multicenter intervention study on the effectiveness of group psychoeducation using depression guidelines for patients to prevent relapse
Scientific Title:Acronym
Group psychoeducation study with depression guidelines for patients
Region
| Japan |
Condition
Condition
Major Depressive Disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to conduct group psychoeducation for patients with depression using the "Easy-to-understand Depression Treatment Guide for Patients and Families" and to examine its impact on patients' understanding of the disease and their quality of life and well-being in the mid- to long-term, which are necessary for preventing relapse.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Patients' understanding of the disease, including prevention of relapse of depression
Key secondary outcomes
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
| Other |
Interventions/Control_1
Group Psychoeducation
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients whose attending physician determines that the current episode meets the criteria for major depressive disorder in the DSM-5
Patients who are judged by the attending physician to be in the recovery or maintenance phase of the current episode
Patients whose primary antidepressant has not been changed (dose reduction is allowed) nor whose primary psychotherapy has not been changed in the past 3 months
Key exclusion criteria
Patients with bipolar disorder
Patients with dementia
Patients with psychotic symptoms
Patients with alcohol or drug dependence
Patients with serious physical illnesses
Patients who are deemed unsuitable by the principal investigator or research coordinator
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Tsuboi |
Organization
Kyorin University School of Medicine
Division name
Department of Neuropsychiatry
Zip code
181-8611
Address
6-20-2, Shinkawa, Mitaka-shi, Tokyo
TEL
0422-47-5511
takashi.tsuboi.0821@gmail.com
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Tsuboi |
Organization
Kyorin University School of Medicine
Division name
Department of Neuropsychiatry
Zip code
181-8611
Address
6-20-2, Shinkawa, Mitaka-shi, Tokyo
TEL
0422-47-5511
Homepage URL
takashi.tsuboi.0821@gmail.com
Sponsor or person
Institute
Kyorin University
Institute
Department
Personal name
Funding Source
Organization
AMED
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 Osaka University Hospital
Address
2-2, Yamadaoka, Suita-shi, Osaka
Tel
06-6210-8296
rinri@hp-crc.med.osaka-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
| 2022 | Year | 12 | Month | 28 | 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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 12 | Month | 19 | Day |
Date of IRB
| 2023 | Year | 01 | Month | 04 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 12 | Month | 28 | Day |
Last modified on
| 2024 | Year | 01 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056872
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
