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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000023520
Receipt No. R000027029
Scientific Title Effect reserch and program development of group behavioral activation for depression
Date of disclosure of the study information 2016/08/06
Last modified on 2019/08/19

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Basic information
Public title Effect reserch and program development of group behavioral activation for depression
Acronym Group behavioral activation for depression
Scientific Title Effect reserch and program development of group behavioral activation for depression
Scientific Title:Acronym Group behavioral activation for depression
Region
Japan

Condition
Condition depression
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study is to inspect the effect of the group behavior activation therapy for the depression patient who does not recover by normal outpatient department treatment enough. By various symptom evaluations and a psychological evaluation, the effect of this therapy is examined.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Hamilton Rating Scale for Depression (HRSD; Hamilton,1967 ).
This scale is carried out at the time of start of therapy and the end of 12 times of sessions.
Key secondary outcomes Montgomery Asberg Depression Rating Scale .
Behavioral Inhibition System / Behavioral Activation System Scale.
Environmental Reward Observation Scale.
Behavioral Activation for Depression Scale.
These scales are carried out at the time of start of therapy and the end of 12 times of sessions.

Beck Depression Inventory-2.
this scale is carried out before 12 times of sessions every time.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 As for the group behavioral activation, it will be carried out 12 sessions. The frequency is 1 session from 90 minutes to 120 minutes once a week.
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
16 years-old <=
Age-upper limit
65 years-old >
Gender Male and Female
Key inclusion criteria 1. The age of subjects is 16 years old to 65 years old.
2. Subjects meet diagnostic criteria of the depression based on DSM-5, and the improvement of the symptom is not seen even if normal outpatients department treatment have been provided more than six months.
3. The subject's score of Hamilton Rating Scale for Depression is 5 point to 20 point.
Key exclusion criteria 1. Subject's score of the Hamilton Rating Scale for Depression is less than five points or is more than 20.
2. Subject has a strong suicide feeling.
3. Subject has comorbidity of the mental disease except depression in diagnostic criteria of DSM-5.
4. Subject receives psychotherapy or counseling other than the medical examination of doctor.
5. Subject is infected with a severe physical disease or is pregnant.
6. The symptom that subject hits is sudden; turn worse, and the chief doctor changes pharmacotherapy.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Yosuke
Middle name
Last name Mochizuki
Organization Hamamatsu University School of Medicine
Division name Department of Psychiatry
Zip code 431-3192
Address 1-20-1, Handayama, Higasi-ku, Hamamatsu city, Shizuoka, 431-3192, Japan.
TEL 053-435-2295
Email yosuke-m@hama-med.ac.jp

Public contact
Name of contact person
1st name Yosuke
Middle name
Last name Mochizuki
Organization Hamamatsu University School of Medicine
Division name Department of Psychiatry
Zip code 431-3192
Address 1-20-1, Handayama, Higasi-ku, Hamamatsu city, Shizuoka, 431-3192, Japan.
TEL 053-435-2295
Homepage URL
Email yosuke-m@hama-med.ac.jp

Sponsor
Institute Hamamatsu University School of Medicene, Department of Psychiatry
Institute
Department

Funding Source
Organization Japan Science and Technology Agency
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 Hamamatsu University School of Medicene
Address 1-20-1, Handayama, Higasi-ku, Hamamatsu city, Shizuoka, 431-3192, Japan.
Tel 053-435-2295
Email rinri@hama-med.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 浜松医科大学医学部附属病院(静岡県)
静岡市こころの健康センター(静岡県)

Other administrative information
Date of disclosure of the study information
2016 Year 08 Month 06 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
2015 Year 08 Month 01 Day
Date of IRB
2016 Year 09 Month 29 Day
Anticipated trial start date
2016 Year 04 Month 01 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
2021 Year 03 Month 31 Day
Date trial data considered complete
2021 Year 03 Month 31 Day
Date analysis concluded
2022 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2016 Year 08 Month 06 Day
Last modified on
2019 Year 08 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027029

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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