UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030324 |
|---|---|
| Receipt number | R000034627 |
| Scientific Title | Study on the effectiveness of Group Psychoeducation Program for the patients with mood disorders |
| Date of disclosure of the study information | 2017/12/08 |
| Last modified on | 2021/06/11 11:19:03 |
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Basic information
Public title
Study on the effectiveness of Group Psychoeducation Program for the patients with mood disorders
Acronym
Study on the effectiveness of Group Psychoeducation Program for the patients with mood disorders
Scientific Title
Study on the effectiveness of Group Psychoeducation Program for the patients with mood disorders
Scientific Title:Acronym
Study on the effectiveness of Group Psychoeducation Program for the patients with mood disorders
Region
| Japan |
Condition
Condition
mood disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the degree of changes of depressive symptoms, cognitive function, feeling of recovery and subjective improvement in the patients with mood disorder who are treated with group psychoeducation program in addition to usual care.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change of the score of Hamilton Rating Scale for Depression, before program, after 3 sessions and after 5 sessions
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
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Group Psychoeducation Program, once a week, total 5 sessions
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) patients aged 20 years and older when at the time of informed consent
2) meet the ICD-10 diagnostic criteria for mood disorder (F3)
3) Written informed consent was obtained on a voluntary basis after full explain about this study
4) permission from the doctor in charge of the patient
Key exclusion criteria
1) patients aged 19 years and younger, or 80 years and older
2) Patients with schizophrenia, mental retardation, alcohol or drug dependence (substance abuse or dependence), dementia, epilepsy, head injury, cerebrovascular accident and so on.
3) Patients with difficulty for conducting cognitive function test
4) Patients who do not consent to join the study
5) Doctor in charge of the patient or a head of research deem the program unsuitable for patients
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Nobuhiro |
| Middle name | |
| Last name | Sugiyama |
Organization
Shinshu University
Division name
School of Health Sciences Department of Applied Occupational Therapy
Zip code
3908621
Address
3-1-1 Asahi Matsumoto Nagano JAPAN
TEL
0263-37-2402
nsugi@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Miku |
| Middle name | |
| Last name | Nakano |
Organization
Shinshu University
Division name
University Hospital Rehabilitation Center
Zip code
3908621
Address
3-1-1 Asahi Matsumoto Nagano JAPAN
TEL
0263-37-2836
Homepage URL
nakano-m5@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University
Institute
Department
Personal name
Funding Source
Organization
None
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
Shinshu University School of Medicine Medical Ethics Committee
Address
3-1-1 Asahi Matsumoto Nagano Japan
Tel
0263-37-2572
mdrinri@shinshu-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
| 2017 | Year | 12 | Month | 08 | 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
Terminated
Date of protocol fixation
| 2017 | Year | 12 | Month | 05 | Day |
Date of IRB
| 2017 | Year | 12 | Month | 07 | Day |
Anticipated trial start date
| 2017 | Year | 03 | Month | 17 | Day |
Last follow-up date
| 2021 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 12 | Month | 08 | Day |
Last modified on
| 2021 | Year | 06 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034627
| 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 |
