UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000029646
Receipt number R000033872
Scientific Title An examination of the effective coping strategy of mental health for university students with major depressive episode: Randomized controlled trial -Hiroshima University GENKI project- (Hug-project)
Date of disclosure of the study information 2017/10/23
Last modified on 2022/06/14 17:32:18

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Basic information

Public title

An examination of the effective coping strategy of mental health for university students with major depressive episode: Randomized controlled trial -Hiroshima University GENKI project- (Hug-project)

Acronym

-Hiroshima University GENKI project-(Hug-project)

Scientific Title

An examination of the effective coping strategy of mental health for university students with major depressive episode: Randomized controlled trial -Hiroshima University GENKI project- (Hug-project)

Scientific Title:Acronym

-Hiroshima University GENKI project-(Hug-project)

Region

Japan


Condition

Condition

depression

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of study is to whether university students with major depressive episode receiving behavioral activation could demonstrate significant decreases in depressive symptom.
Also, the secondary objective of this study is to examine long-term (1 year) effect of depressive symptoms and significant change of brain function by carrying out behavioral activation.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Beck Depression Inventory (BDI)- II

Key secondary outcomes

1) Patient Health Questionnare-9 (PHQ-9)
2) (GRID-Hamilton Depression Rating Scale (GRID-HAM-D)
3) Behavioral Activation for Depression Scale (BADS)
4) Environmental Reward Observation Scale (EROS)
5) Euro Qol scale (EQ-5D)
6) Personal Values Questionnaire II (PVQ-II)
7) Valuing Questionnaire (VQ)
8) Generalized Self-Efficacy Scale (SE)
9) Eating Attitudes Test (EAT)
10) Bulimic Investigatory Test, Edinburgh (BITE)
11) fMRI
12) Behavior / physiological examination


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation


Institution consideration


Blocking


Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Behavior,custom

Interventions/Control_1

In experimental group, we carry out care as usual and behavioral activation.
Treatment of behavioral activation consisted of 10 weekly 60-min sessions.

Interventions/Control_2

In control group, we carry out care as usual.

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

24 years-old >=

Gender

Male and Female

Key inclusion criteria

1) University students in 18-24 years old in Hiroshima University.

2) University students who scored 18 or higher on the BDI-II.

3) University students were diagnosed with Major Depressive episode and judged to be able to receive counseling treatment.

4) University students who were meeting Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV) criteria for Major Depressive episode using by CIDI

5) University students who got informed consent of participation of study and recording session contents

6) University students who have been able to live a university life as usual by a psychiatrist's diagnosis

Key exclusion criteria

1) Apart from care as usual at the Health Service Center, University students who currently receiving medication and psychotherapy for treatment

2) University students who can not understand purpose of the study by serious mental state

3) University students who can not endure investigation by serious physical disease

4)University students who were meeting Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV) criteria for bipolar disorder

Target sample size

52


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yasumasa Okamoto

Organization

Graduate School of Biomedical and Health Sciences, Hiroshima University

Division name

Department of Psychiatry and Neurosciences, Hiroshima University

Zip code


Address

1-2-3 Kasumi, Minami-ku, Hiroshima

TEL

082-257-5208

Email

oy@hiroshima-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Koki Takagaki

Organization

Graduate School of Biomedical and Health Sciences, Hiroshima University

Division name

Department of Psychiatry and Neurosciences

Zip code


Address

1-2-3 Kasumi, Minami-ku, Hiroshima

TEL

082-257-5208

Homepage URL


Email

koki.takagaki@gmail.com


Sponsor or person

Institute

Department of Psychiatry and Neurosciences, Graduate School of Biomedical and Health Sciences, Hiroshima University

Institute

Department

Personal name



Funding Source

Organization

Japan Society for the Promotion of Science (JSPS), Grant-in-Aid for Scientific Research (KAKENHI)

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


Address


Tel


Email



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 10 Month 23 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 10 Month 11 Day

Date of IRB

2017 Year 09 Month 28 Day

Anticipated trial start date

2017 Year 11 Month 01 Day

Last follow-up date

2025 Year 03 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

2017 Year 10 Month 21 Day

Last modified on

2022 Year 06 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033872


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name