UMIN-CTR Clinical Trial

Basic information
Public title	Randomized Controlled Trial of Behavioral Activation Group Therapy for Depression in Undergraduate Students
Acronym	Behavioral Activation Group Therapy for Depression in Undergraduate Students
Scientific Title	Randomized Controlled Trial of Behavioral Activation Group Therapy for Depression in Undergraduate Students
Scientific Title:Acronym	Behavioral Activation Group Therapy for Depression in Undergraduate Students
Region	Japan

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

Objectives
Narrative objectives1	The purpose of the present study is to examine the effect of behavioral activation group therapy for depression in undergraduate students .
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Patient Health Questionnaire 9
Key secondary outcomes	1)Beck Depression Inventory Second Edition 2)Behavioral Activation for Depression Scale(Short Form) 3)Reward Probability Index 4)Social Adaptation Self evaluation Scale 5)Work and Social Adjustment Scale 6)World Health Organization Quality of Life 26

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Behavior,custom
Interventions/Control_1	In experimental group, we conduct behavioral activation group therapy. Treatment of behavioral activation group therapy consists of 4 weekly 90-min sessions.
Interventions/Control_2	In control group, we do not conduct any intervention.
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)Undergraduate students in 18-24 years old in Chukyo University. 2) Undergraduate students who scored 5 or higher on the PHQ-9.
Key exclusion criteria	1)Undergraduate students with strong suicidal ideation. 2)Undergraduate students who currently receiving medication and psychotherapy for treatment 3)Undergraduate students who have met criteria for bipolar disorder.
Target sample size	50

Research contact person
Last name of lead principal investigator	1st name Makoto Middle name Last name Sakai
Organization	Chukyo University
Division name	School of Psychology
Zip code	466-8666
Address	101-2 Yagoto Honmachi, Showa-ku Nagoya-City, Aichi Pref., Japan
TEL	052-835-7160
Email	saka-ms@lets.chukyo-u.ac.jp

Public contact
1st name of contact person	1st name Tatsuya Middle name Last name Yamamoto
Organization	Chukyo University
Division name	School of Psychology
Zip code	466-8666
Address	101-2 Yagoto Honmachi, Showa-ku Nagoya-City, Aichi Pref., Japan
TEL	052-835-7160
Homepage URL
Email	tatsuya@lets.chukyo-u.ac.jp

Sponsor
Institute	School of Psychology, Chukyo 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	Research Ethics Committee of Chukyo University
Address	101-2 Yagoto Honmachi, Showa-ku Nagoya-City, Aichi Pref., Japan
Tel	052-835-7111
Email	kenkyurinri@mng.chukyo-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 11 Month 01 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	12
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	Completed
Date of protocol fixation	2018 Year 01 Month 16 Day
Date of IRB	2018 Year 01 Month 16 Day
Anticipated trial start date	2018 Year 04 Month 01 Day
Last follow-up date	2019 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 11 Month 01 Day
Last modified on	2019 Year 04 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034033