UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A Study on Effectiveness of Rational Emotive Education among college students
Title of the study (Brief title)	A Study on Effectiveness of Rational Emotive Education among college students
Region	Japan

Condition
Condition	non clinical depression
Classification by specialty	Adult Child
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the effects of a brief depression prevention program based on the principle of Cognitive Therapy (CT) and Rational Emotive Behavior Therapy (REBT) for college students.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	NIMH Center for Epidemiologic Studies - Depression Scale (CES-D) Evaluation was made at 1 month and 2 months after group education program implementation.
Key secondary outcomes	1. The Kessler 6 scale (K6) 2. Automatic Thoughts Questionnare - Revised (ATQ-R) 3. Japan Irrational Belief Test-20 (JIBT-20) Evaluation was made at 1 month and 2 months after group education program implementation.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	Group education based on cognitive therapy and REBT principle (1.5 hours). Home work tackled by individuals based on the contents of group education (2 months).
Interventions/Control_2	Participants in the control group watched an educational DVD on psychology in groups, then wrote impressions(1.5 hours). No home work was imposed.
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	Students who take the relevant College lessons.
Key exclusion criteria	None.
Target sample size	128

Research contact person
Name of lead principal investigator	Katsutoshi Tanaka
Organization	Kitasato University
Division name	Graduate School of Medical Sciences
Address	1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa 252-0373, Japan
TEL	042-778-9305
Email	k-tanaka@kitasato-u.ac.jp

Public contact
Name of contact person	Hikaru Araki
Organization	Kitasato University
Division name	Graduate School of Medical Sciences
Address	1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa 252-0373, Japan
TEL	042-778-9305
Homepage URL
Email	dm15002z@st.kitasato-u.ac.jp

Sponsor
Institute	Kitasato University
Institute
Department

Funding Source
Organization	Kitasato University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2018 Year 12 Month 11 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 08 Month 01 Day
Anticipated trial start date	2016 Year 09 Month 12 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2018 Year 12 Month 10 Day
Last modified on	2018 Year 12 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040111