UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000023520
Receipt number 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 2020/03/07 16:05:57

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 or person

Institute

Hamamatsu University School of Medicene, Department of Psychiatry

Institute

Department

Personal name



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

Partially published


Result

URL related to results and publications

https://kaken.nii.ac.jp/ja/file/KAKENHI-PROJECT-15K04119/15K04119seika.pdf

Number of participants that the trial has enrolled

26

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

No longer 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

2020 Year 03 Month 07 Day



Link to view the page

Value
https://center6.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