UMIN-CTR Clinical Trial

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
Email	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
Email	nakano-m5@shinshu-u.ac.jp

Sponsor
Institute	Shinshu University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000034627